<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02978781</url>
  </required_header>
  <id_info>
    <org_study_id>217-ETD-201</org_study_id>
    <nct_id>NCT02978781</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate SAGE-217 in Participants With Essential Tremor</brief_title>
  <official_title>A Phase 2a, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of SAGE-217 in the Treatment of Subjects With Essential Tremor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sage Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sage Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety,&#xD;
      tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part A of the study was an open-label design with morning dosing of SAGE-217 for 7 days and&#xD;
      included 16 participants, 8 of whom qualified for, and entered, Part B.&#xD;
&#xD;
      Part B had a double-blind, placebo-controlled, randomized withdrawal design with morning&#xD;
      dosing for 7 days.&#xD;
&#xD;
      Part C was an open-label design with morning and evening dosing for 14 days and included a&#xD;
      different set of 18 participants.&#xD;
&#xD;
      Parts A and B were stopped early (in advance of the planned sample size).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 24, 2017</start_date>
  <completion_date type="Actual">December 5, 2017</completion_date>
  <primary_completion_date type="Actual">November 22, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part A: Change From Baseline in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 7</measure>
    <time_frame>Baseline (Day 1) and Day 7 (8 hours postdose)</time_frame>
    <description>The accelerometer-based Kinesia kinetic tremor combined score is the sum of Kinesia kinetic tremor scores across both sides of the body. Tremor is measured using a motion sensor that transmits raw data to a computer where it converts the tremor amplitude to a Kinesia score of 0 to 4 based on validated algorithms; the total score ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part B: Change From Randomization in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 14</measure>
    <time_frame>Randomization (Day 8, predose) and Day 14 (predose)</time_frame>
    <description>The accelerometer-based Kinesia kinetic tremor combined score is the sum of Kinesia kinetic tremor scores across both sides of the body. Tremor is measured using a motion sensor that transmits raw data to a computer where it converts the tremor amplitude to a Kinesia score of 0 to 4 based on validated algorithms; the total score ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part C: Change From Baseline in the Accelerometer-based Kinesia Upper Limb Tremor Combined Score at Day 15</measure>
    <time_frame>Baseline (Day 1) and Day 15</time_frame>
    <description>The accelerometer-based Kinesia upper limb total score is the sum of the individual item scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part A: Change From Baseline in Kinesia Upper Limb Total Score at Day 7</measure>
    <time_frame>Baseline (Day 1) and Day 7 (8 hours postdose)</time_frame>
    <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Change From Baseline in Kinesia Upper Limb Individual Item Score at Day 7</measure>
    <time_frame>Baseline (Day 1) and Day 7 (8 hours [hr] postdose [pd])</time_frame>
    <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4, with higher scores indicating more tremors/greater tremor amplitude. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Change From Baseline in the Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Total Score at Day 7</measure>
    <time_frame>Baseline (Day 1) and Day 7 (8 hours postdose)</time_frame>
    <description>The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. The TETRAS individual item score included TETRAS Performance Subscale item 4a, 4b and 4c scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT) scores and 4c: Kinetic tremor (KT) score] from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the TETRAS Upper Limb Individual Items (Performance Subscale Items 4a, 4b, or 4c) Scores at Day 7</measure>
    <time_frame>Baseline (Day 1) and Day 7 (8 hours postdose)</time_frame>
    <description>The TETRAS individual item score is the sum of the TETRAS Performance Subscale items 4a, 4b, or 4c scores [4a: forward outstretched postural tremor (FOPT), 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT), 4c: kinetic tremor] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16; higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Change From Baseline in TETRAS Performance Subscale Score (Items 6, 7, and 8) at Day 7</measure>
    <time_frame>Baseline (Day 1) and Day 7 (predose)</time_frame>
    <description>The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Change From Randomization in the Kinesia Upper Limb Total Score at Day 14</measure>
    <time_frame>Randomization (Day 8, predose) and Day 14 (predose)</time_frame>
    <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Randomization indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Change From Randomization in the Kinesia Upper Limb Individual Item Score at Day 14</measure>
    <time_frame>Randomization (Day 8, predose) and Day 14 (predose)</time_frame>
    <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Randomization indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Change From Randomization in the TETRAS Upper Limb Total Score at Day 14</measure>
    <time_frame>Randomization (Day 8, predose) and Day 14 (predose)</time_frame>
    <description>The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. The TETRAS individual item score included TETRAS Performance Subscale item 4a, 4b and 4c scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT) scores and 4c: Kinetic tremor (KT) score] from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Change From Randomization in the TETRAS Upper Limb Individual Item (Performance Subscale Items 4a and 4b) Score at Day 14</measure>
    <time_frame>Randomization (Day 8, predose) and Day 14 (predose)</time_frame>
    <description>The TETRAS individual item score is the sum of the TETRAS Performance Subscale item 4a and 4b scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT) scores] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Change From Randomization in the TETRAS Performance Subscale Item 4c (Kinetic Tremor) Combined Score at Day 14</measure>
    <time_frame>Randomization (Day 8, predose) and Day 14 (predose)</time_frame>
    <description>The TETRAS kinetic tremor combined score is the sum of the TETRAS Performance Subscale item 4c (kinetic tremor) scores from both sides of the body. The TETRAS kinetic tremor score ranges from 0 to 4, the total score for both sides of the body ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Change From Baseline in TETRAS Performance Subscale (Items 6, 7, and 8) Score at Day 14</measure>
    <time_frame>Baseline (Day 1) and Day 14 (predose)</time_frame>
    <description>The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Change From Baseline in the Kinesia Upper Limb Individual Item Score at Day 15</measure>
    <time_frame>Baseline (Day 1) and Day 15</time_frame>
    <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Change From Baseline in the TETRAS Upper Limb Total Score at Day 15</measure>
    <time_frame>Baseline (Day 1) and Day 15</time_frame>
    <description>The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Change From Baseline in the TETRAS Upper Limb Individual Item (Performance Subscale Items 4a and 4b) Score at Day 15</measure>
    <time_frame>Baseline (Day 1) and Day 15</time_frame>
    <description>The TETRAS individual item score is the sum of the TETRAS Performance Subscale item 4a and 4b scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT) scores] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16, higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Change From Baseline in TETRAS Performance Subscale (Items 6, 7, and 8) Scores at Day 15</measure>
    <time_frame>Baseline (Day 1) and Day 15</time_frame>
    <description>The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A, B and C: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) or Serious Adverse Event (SAE)</measure>
    <time_frame>From first dose of study drug through 14 days after the last dose (Up to 28 days)</time_frame>
    <description>An Adverse Event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Adverse events that occurred after the first administration of study drug were denoted as TEAEs. A Serious Adverse Event (SAE) was an AE occurring during any study phase and at any dose of the study drug, comparator, or placebo, that fulfilled the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A, B and C: Number of Participants With Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score</measure>
    <time_frame>Baseline and post-baseline (up to 28 days)</time_frame>
    <description>The C-SSRS consists of a baseline and post-baseline (PB) evaluation that assesses the lifetime experience of the participants with suicidal ideation and behavior. The data for suicidal ideation were summarized for participants who answered 'Yes'. Suicide ideation was categorized as 1) wish to be dead and 2) non-specific active suicidal thoughts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Vital Signs</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Vital signs included heart rate, respiratory rate, temperature, and blood pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Laboratory Parameters</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Laboratory parameters included hematology, blood chemistry, and urinalysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Electrocardiogram (ECG) Values</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>A 12-lead ECG was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A and B: Change From Baseline in Stanford Sleepiness Scale (SSS)</measure>
    <time_frame>Baseline (Day 1), Day 7 (predose) for Part A, Day 14 (predose) for Part B</time_frame>
    <description>The SSS was designed to quickly assess how alert a subject is feeling. Degrees of sleepiness and alertness are rated on a scale of 1 to 7, where the lowest score of 1 indicates the subject is &quot;feeling active, vital, alert, or wide awake&quot; and the highest score of 7 indicates the participant is &quot;no longer fighting sleep, sleep onset soon; having dream-like thoughts&quot;. Greater changes from baseline indicate greater sedation. A positive change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A, B and C: Change From Baseline in Bond-Lader Visual Analogue Scale (VAS) Score</measure>
    <time_frame>Baseline (Day 1), Day 7 (predose) for Part A, Day 14 (predose) for Part B and Day 15 for Part C</time_frame>
    <description>Mood was assessed using the Bond-Lader VAS score. This is a 16-part self-administered questionnaire that employs a 100-mm VAS to explore different aspects of self-reported mood. Three factor scores for (alertness, contentedness, and calmness) were calculated using following equations based on normalized VAS scores:&#xD;
Alertness = 0.827X1 + 0.618X3 + 0.755X4 + 0.642X5 + 0.776X6 + 0.635X9 + 0.792X11 + 0.593X12 + 0.614X15;&#xD;
Contentedness = 0.677X7 + 0.697X8 + 0.823X13 + 0.738X14 + 0.594X16; and&#xD;
Calmness = 0.845X2 + 0.677X10,&#xD;
where Xi represents a subject's item score after normalization, and i represents the item number from the entire scale (in order from 1-16). A negative change from baseline (CFB) indicated more alertness, more contentedness, and more calmness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A, B and C: Participant's Feeling After Taking the Study Drug as Assessed by Drug Effects Questionnaire (DEQ-5) Score</measure>
    <time_frame>Baseline (Day 1), Day 7 (2 hours postdose) for Part A, Day 14 (2 hours postdose) for Part B and Day 15 for Part C</time_frame>
    <description>Participants responded to 5 DEQs based on how they are feeling after taking the study drug. DEQ-5 were as follows; Q1: Do you FEEL a drug effect right now? Q2: Are you HIGH right now? Q3: Do you DISLIKE any of the effects that you are feeling right now? Q4: Do you LIKE any of the effects that you are feeling right now? Q5: Would you like MORE of the drug you took, right now? The answers were recorded on a 100-mm VAS, with the answer for each being &quot;Not at all&quot; (0 mm) and &quot;Extremely&quot; (100 mm) at the extremes. There were options to record &quot;Not applicable&quot; for questions 3 and 4 if no drug effects were felt and for question 5 prior to administration of study medication, and these participants were excluded from the data summarization. Higher score on Q1 indicates a drug effect; on Q2 indicates feeling high; on Q3 indicates disliking the drug; and on Q4 and Q5 indicates liking the drug.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Essential Tremor</condition>
  <arm_group>
    <arm_group_label>Part A: SAGE-217 Oral Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received SAGE-217 10 mg oral solution on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 with food in the morning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: SAGE-217 Capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: SAGE-217 Capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C: SAGE-217 Capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAGE-217</intervention_name>
    <description>SAGE-217 Oral Solution</description>
    <arm_group_label>Part A: SAGE-217 Oral Solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAGE-217</intervention_name>
    <description>SAGE-217 Capsules</description>
    <arm_group_label>Part A: SAGE-217 Capsules</arm_group_label>
    <arm_group_label>Part B: SAGE-217 Capsules</arm_group_label>
    <arm_group_label>Part C: SAGE-217 Capsules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>SAGE-217 matching placebo capsules</description>
    <arm_group_label>Part B: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral&#xD;
             postural tremor and kinetic tremor, involving hands and forearms, that is visible and&#xD;
             persistent and the duration is &gt;5 years prior to screening.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Participant has presence of abnormal neurological signs other than tremor or Froment's&#xD;
             sign.&#xD;
&#xD;
          -  Participant has presence of known causes of enhanced physiological tremor.&#xD;
&#xD;
          -  Participant has concurrent or recent exposure (14 days prior to admission visit) to&#xD;
             tremorogenic drugs.&#xD;
&#xD;
          -  Participant has had direct or indirect trauma to the nervous system within 3 months&#xD;
             before the onset of tremor.&#xD;
&#xD;
          -  Participant has historical or clinical evidence of tremor with psychogenic origin.&#xD;
&#xD;
          -  Participant has convincing evidence of sudden tremor onset or evidence of stepwise&#xD;
             deterioration of tremor.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Silber, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sage Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Cerritos</city>
        <state>California</state>
        <zip>90703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Lauderdale Lakes</city>
        <state>Florida</state>
        <zip>33319</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.sagerx.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>November 21, 2020</results_first_submitted>
  <results_first_submitted_qc>January 29, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 17, 2021</results_first_posted>
  <disposition_first_submitted>November 21, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>January 29, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 17, 2021</disposition_first_posted>
  <last_update_submitted>January 20, 2022</last_update_submitted>
  <last_update_submitted_qc>January 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tremor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tremor</mesh_term>
    <mesh_term>Essential Tremor</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT02978781/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT02978781/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 34 participants were enrolled in the study from 11 investigation sites in United States.</recruitment_details>
      <pre_assignment_details>A total of 34 participants enrolled in the study. 16 participants received either SAGE-217 oral solution (N=2) or capsules (N=14) in Part A; 8 participants who tolerated a dose ≥10 mg in Part A and achieved response on Day 8 were randomized (1:1) in Part B to Placebo or SAGE-217 capsules.18 participants received SAGE-217 capsules in Part C.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part A: SAGE-217 Oral Solution</title>
          <description>Participants received SAGE-217 10 mg oral solution on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 with food in the morning.</description>
        </group>
        <group group_id="P2">
          <title>Part A: SAGE-217 Capsules</title>
          <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.</description>
        </group>
        <group group_id="P3">
          <title>Part B: Placebo</title>
          <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response (≥30% reduction in kinetic tremor) on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.</description>
        </group>
        <group group_id="P4">
          <title>Part B: SAGE-217 Capsules</title>
          <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive maximum tolerated SAGE-217 in Part A for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.</description>
        </group>
        <group group_id="P5">
          <title>Part C: SAGE-217 Capsules</title>
          <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part A</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part B</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4">Include participants who tolerated a dose ≥10 mg in Part A and achieved response on Day 8.</participants>
                <participants group_id="P4" count="4">Include participants who tolerated a dose ≥10 mg in Part A and achieved response on Day 8.</participants>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part C</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Tremor not improved due to Topamax discontinuation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety population included participants who received at least one dose of study drug in Part A and Part C. Participants who were randomized in Part B are not displayed here, as they are the same participants who tolerated study drug and were in the safety population for Part A. Part B participants are captured in the efficacy population.</population>
      <group_list>
        <group group_id="B1">
          <title>Part A: SAGE-217 Oral Solution</title>
          <description>Participants received SAGE-217 10 mg on Day 1, 20 mg on Day 2 and 30 mg daily on Days 3 to 7 as an oral solution with food in the morning.</description>
        </group>
        <group group_id="B2">
          <title>Part A: SAGE-217 Capsules</title>
          <description>Participants received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.</description>
        </group>
        <group group_id="B3">
          <title>Part C: SAGE-217 Capsules</title>
          <description>Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="18"/>
            <count group_id="B4" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.5" spread="0.71"/>
                    <measurement group_id="B2" value="62.4" spread="8.34"/>
                    <measurement group_id="B3" value="65.8" spread="8.21"/>
                    <measurement group_id="B4" value="64.7" spread="8.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Part A: Change From Baseline in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 7</title>
        <description>The accelerometer-based Kinesia kinetic tremor combined score is the sum of Kinesia kinetic tremor scores across both sides of the body. Tremor is measured using a motion sensor that transmits raw data to a computer where it converts the tremor amplitude to a Kinesia score of 0 to 4 based on validated algorithms; the total score ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (Day 1) and Day 7 (8 hours postdose)</time_frame>
        <population>Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Change From Baseline in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 7</title>
          <description>The accelerometer-based Kinesia kinetic tremor combined score is the sum of Kinesia kinetic tremor scores across both sides of the body. Tremor is measured using a motion sensor that transmits raw data to a computer where it converts the tremor amplitude to a Kinesia score of 0 to 4 based on validated algorithms; the total score ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
          <population>Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.36" spread="1.199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 7 (8 hours postdose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="1.115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part B: Change From Randomization in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 14</title>
        <description>The accelerometer-based Kinesia kinetic tremor combined score is the sum of Kinesia kinetic tremor scores across both sides of the body. Tremor is measured using a motion sensor that transmits raw data to a computer where it converts the tremor amplitude to a Kinesia score of 0 to 4 based on validated algorithms; the total score ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.</description>
        <time_frame>Randomization (Day 8, predose) and Day 14 (predose)</time_frame>
        <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Placebo</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
          <group group_id="O2">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Change From Randomization in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 14</title>
          <description>The accelerometer-based Kinesia kinetic tremor combined score is the sum of Kinesia kinetic tremor scores across both sides of the body. Tremor is measured using a motion sensor that transmits raw data to a computer where it converts the tremor amplitude to a Kinesia score of 0 to 4 based on validated algorithms; the total score ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.</description>
          <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Randomization (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.33" spread="0.714"/>
                    <measurement group_id="O2" value="4.13" spread="1.438"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Randomization at Day 14 (predose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.271"/>
                    <measurement group_id="O2" value="0.15" spread="0.191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Randomization at Day 14 (predose)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9143</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.227</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.44</ci_lower_limit>
            <ci_upper_limit>0.49</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Randomization (SAGE-217 - placebo)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part C: Change From Baseline in the Accelerometer-based Kinesia Upper Limb Tremor Combined Score at Day 15</title>
        <description>The accelerometer-based Kinesia upper limb total score is the sum of the individual item scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (Day 1) and Day 15</time_frame>
        <population>The Efficacy Population consisted of all participants who completed at least 1 dose of study drug in Part C and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening).</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Change From Baseline in the Accelerometer-based Kinesia Upper Limb Tremor Combined Score at Day 15</title>
          <description>The accelerometer-based Kinesia upper limb total score is the sum of the individual item scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.</description>
          <population>The Efficacy Population consisted of all participants who completed at least 1 dose of study drug in Part C and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.68" spread="3.822"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.22" spread="2.956"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Day 15</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0529</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.74</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.815</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.50</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Change From Baseline in Kinesia Upper Limb Total Score at Day 7</title>
        <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (Day 1) and Day 7 (8 hours postdose)</time_frame>
        <population>Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Change From Baseline in Kinesia Upper Limb Total Score at Day 7</title>
          <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.</description>
          <population>Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given timepoint.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.50" spread="4.395"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 7 (8 hours postdose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.40" spread="3.395"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Change From Baseline in Kinesia Upper Limb Individual Item Score at Day 7</title>
        <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4, with higher scores indicating more tremors/greater tremor amplitude. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (Day 1) and Day 7 (8 hours [hr] postdose [pd])</time_frame>
        <population>Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Change From Baseline in Kinesia Upper Limb Individual Item Score at Day 7</title>
          <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4, with higher scores indicating more tremors/greater tremor amplitude. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.</description>
          <population>Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given timepoint.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FOPT at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.51" spread="1.749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in FOPT at Day 7 (8 hr pd)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.74" spread="1.339"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LWBPT at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.63" spread="1.695"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in LWBPT at Day 7 (8 hr pd)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.97" spread="1.312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kinetic tremor at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.36" spread="1.199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Change From Baseline in the Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Total Score at Day 7</title>
        <description>The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. The TETRAS individual item score included TETRAS Performance Subscale item 4a, 4b and 4c scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT) scores and 4c: Kinetic tremor (KT) score] from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change indicates improvement.</description>
        <time_frame>Baseline (Day 1) and Day 7 (8 hours postdose)</time_frame>
        <population>Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Change From Baseline in the Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Total Score at Day 7</title>
          <description>The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. The TETRAS individual item score included TETRAS Performance Subscale item 4a, 4b and 4c scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT) scores and 4c: Kinetic tremor (KT) score] from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change indicates improvement.</description>
          <population>Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.86" spread="2.373"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.42" spread="2.964"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the TETRAS Upper Limb Individual Items (Performance Subscale Items 4a, 4b, or 4c) Scores at Day 7</title>
        <description>The TETRAS individual item score is the sum of the TETRAS Performance Subscale items 4a, 4b, or 4c scores [4a: forward outstretched postural tremor (FOPT), 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT), 4c: kinetic tremor] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16; higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (Day 1) and Day 7 (8 hours postdose)</time_frame>
        <population>Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the TETRAS Upper Limb Individual Items (Performance Subscale Items 4a, 4b, or 4c) Scores at Day 7</title>
          <description>The TETRAS individual item score is the sum of the TETRAS Performance Subscale items 4a, 4b, or 4c scores [4a: forward outstretched postural tremor (FOPT), 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT), 4c: kinetic tremor] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16; higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
          <population>Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FOPT at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.14" spread="0.989"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in FOPT at Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.46" spread="1.070"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LWBPT at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.18" spread="0.932"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in LWBPT at Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.31" spread="1.011"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kinetic Tremor at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.54" spread="0.720"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in Kinetic Tremor at Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.65" spread="1.179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Change From Baseline in TETRAS Performance Subscale Score (Items 6, 7, and 8) at Day 7</title>
        <description>The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (Day 1) and Day 7 (predose)</time_frame>
        <population>Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Change From Baseline in TETRAS Performance Subscale Score (Items 6, 7, and 8) at Day 7</title>
          <description>The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
          <population>Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AS at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="1.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in AS at Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Handwriting at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in Handwriting at Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAT at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.46" spread="0.692"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in DAT at Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.96" spread="0.967"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Change From Randomization in the Kinesia Upper Limb Total Score at Day 14</title>
        <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Randomization indicates improvement.</description>
        <time_frame>Randomization (Day 8, predose) and Day 14 (predose)</time_frame>
        <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Placebo</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
          <group group_id="O2">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Change From Randomization in the Kinesia Upper Limb Total Score at Day 14</title>
          <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Randomization indicates improvement.</description>
          <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Randomization (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.33" spread="2.373"/>
                    <measurement group_id="O2" value="9.13" spread="7.236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Randomization at Day 14 (predose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="2.380"/>
                    <measurement group_id="O2" value="0.55" spread="0.520"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Randomization at Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7795</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.326</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.47</ci_lower_limit>
            <ci_upper_limit>2.70</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Randomization (SAGE-217 - placebo)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Change From Randomization in the Kinesia Upper Limb Individual Item Score at Day 14</title>
        <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Randomization indicates improvement.</description>
        <time_frame>Randomization (Day 8, predose) and Day 14 (predose)</time_frame>
        <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Placebo</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
          <group group_id="O2">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Change From Randomization in the Kinesia Upper Limb Individual Item Score at Day 14</title>
          <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Randomization indicates improvement.</description>
          <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FOPT at Randomization (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.60" spread="1.098"/>
                    <measurement group_id="O2" value="1.85" spread="2.983"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Randomization in FOPT at Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.580"/>
                    <measurement group_id="O2" value="0.38" spread="0.591"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LWBPT at Randomization (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.40" spread="0.876"/>
                    <measurement group_id="O2" value="3.15" spread="3.032"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Randomization in LWBPT at Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" spread="1.553"/>
                    <measurement group_id="O2" value="0.03" spread="0.263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Randomization in Forward outstretched postural tremor (FOPT) at Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4846</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>0.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.473</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.65</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Randomization (SAGE-217 - placebo)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Randomization in Lateral &quot;wing beating&quot; postural tremor (LWBPT) at Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4567</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.67</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.845</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.70</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Randomization (SAGE-217 - placebo)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Change From Randomization in the TETRAS Upper Limb Total Score at Day 14</title>
        <description>The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. The TETRAS individual item score included TETRAS Performance Subscale item 4a, 4b and 4c scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT) scores and 4c: Kinetic tremor (KT) score] from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.</description>
        <time_frame>Randomization (Day 8, predose) and Day 14 (predose)</time_frame>
        <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Placebo</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
          <group group_id="O2">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Change From Randomization in the TETRAS Upper Limb Total Score at Day 14</title>
          <description>The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. The TETRAS individual item score included TETRAS Performance Subscale item 4a, 4b and 4c scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT) scores and 4c: Kinetic tremor (KT) score] from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.</description>
          <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Randomization (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.88" spread="1.436"/>
                    <measurement group_id="O2" value="7.63" spread="4.956"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Randomization at Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.38" spread="1.109"/>
                    <measurement group_id="O2" value="0.63" spread="0.250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Randomization at Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3771</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.76</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.850</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.48</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Randomization (SAGE-217 - placebo)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Change From Randomization in the TETRAS Upper Limb Individual Item (Performance Subscale Items 4a and 4b) Score at Day 14</title>
        <description>The TETRAS individual item score is the sum of the TETRAS Performance Subscale item 4a and 4b scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT) scores] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.</description>
        <time_frame>Randomization (Day 8, predose) and Day 14 (predose)</time_frame>
        <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Placebo</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
          <group group_id="O2">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Change From Randomization in the TETRAS Upper Limb Individual Item (Performance Subscale Items 4a and 4b) Score at Day 14</title>
          <description>The TETRAS individual item score is the sum of the TETRAS Performance Subscale item 4a and 4b scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT) scores] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.</description>
          <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FOPT at Randomization (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.75" spread="0.500"/>
                    <measurement group_id="O2" value="2.63" spread="1.702"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Randomization in FOPT at Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.629"/>
                    <measurement group_id="O2" value="0.00" spread="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LWBPT at Randomization (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.63" spread="0.479"/>
                    <measurement group_id="O2" value="2.63" spread="2.056"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Randomization in LWBPT at Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="0.629"/>
                    <measurement group_id="O2" value="0.25" spread="0.645"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Randomization in Forward outstretched postural tremor (FOPT) at Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7302</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.415</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.97</ci_lower_limit>
            <ci_upper_limit>0.69</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Randomization (SAGE-217 - placebo)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Randomization in Lateral &quot;wing beating&quot; postural tremor (LWBPT) at Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7916</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.467</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.10</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Randomization (SAGE-217 - placebo)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Change From Randomization in the TETRAS Performance Subscale Item 4c (Kinetic Tremor) Combined Score at Day 14</title>
        <description>The TETRAS kinetic tremor combined score is the sum of the TETRAS Performance Subscale item 4c (kinetic tremor) scores from both sides of the body. The TETRAS kinetic tremor score ranges from 0 to 4, the total score for both sides of the body ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.</description>
        <time_frame>Randomization (Day 8, predose) and Day 14 (predose)</time_frame>
        <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Placebo</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
          <group group_id="O2">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Change From Randomization in the TETRAS Performance Subscale Item 4c (Kinetic Tremor) Combined Score at Day 14</title>
          <description>The TETRAS kinetic tremor combined score is the sum of the TETRAS Performance Subscale item 4c (kinetic tremor) scores from both sides of the body. The TETRAS kinetic tremor score ranges from 0 to 4, the total score for both sides of the body ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.</description>
          <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Randomization (Day 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" spread="0.577"/>
                    <measurement group_id="O2" value="2.38" spread="1.250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Randomization at Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.88" spread="0.479"/>
                    <measurement group_id="O2" value="0.38" spread="0.479"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Randomization at Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1807</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.340</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.17</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Randomization (SAGE-217 - placebo)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Change From Baseline in TETRAS Performance Subscale (Items 6, 7, and 8) Score at Day 14</title>
        <description>The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (Day 1) and Day 14 (predose)</time_frame>
        <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Placebo</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
          <group group_id="O2">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Change From Baseline in TETRAS Performance Subscale (Items 6, 7, and 8) Score at Day 14</title>
          <description>The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
          <population>The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AS at Baseline (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="0.82"/>
                    <measurement group_id="O2" value="5.3" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in AS at Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="0.96"/>
                    <measurement group_id="O2" value="-1.0" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Handwriting at Baseline (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="0.96"/>
                    <measurement group_id="O2" value="3.0" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in Handwriting at Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="1.00"/>
                    <measurement group_id="O2" value="-0.5" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAT at Baseline (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.63" spread="0.629"/>
                    <measurement group_id="O2" value="4.50" spread="1.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in DAT at Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.25" spread="0.866"/>
                    <measurement group_id="O2" value="-1.38" spread="1.250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in Archimedes Spirals (AS) at Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8709</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.72</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.7</ci_lower_limit>
            <ci_upper_limit>1.9</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline(SAGE-217 - placebo)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in Handwriting at Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7843</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.65</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>1.4</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217 - placebo)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in Dot approximation task (DAT) at Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7604</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.984</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.72</ci_lower_limit>
            <ci_upper_limit>2.10</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217 - placebo</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Change From Baseline in the Kinesia Upper Limb Individual Item Score at Day 15</title>
        <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (Day 1) and Day 15</time_frame>
        <population>The Efficacy Population consisted of all participants who completed at least 1 dose of study drug in the capsule formulation in Part C and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening).</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Change From Baseline in the Kinesia Upper Limb Individual Item Score at Day 15</title>
          <description>The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral &quot;wing beating&quot; postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.</description>
          <population>The Efficacy Population consisted of all participants who completed at least 1 dose of study drug in the capsule formulation in Part C and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FOPT at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.98" spread="1.626"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in FOPT at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.53" spread="1.156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LWBPT at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.41" spread="1.548"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in LWBPT at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.93" spread="1.497"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kinetic tremor at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.28" spread="1.275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in Kinetic tremor at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.51" spread="1.229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in Forward outstretched postural tremor (FOPT) at Day 15</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1333</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.301</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.13</ci_lower_limit>
            <ci_upper_limit>0.17</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in Lateral &quot;wing beating&quot; postural tremor (LWBPT) at Day 15</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0572</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.81</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.389</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.64</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in Kinetic tremor (KT) at Day 15</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0707</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.50</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.255</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.05</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Change From Baseline in the TETRAS Upper Limb Total Score at Day 15</title>
        <description>The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change indicates improvement.</description>
        <time_frame>Baseline (Day 1) and Day 15</time_frame>
        <population>The Efficacy Population consisted of all participants who completed at least 1 dose of study drug in the capsule formulation in Part C and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening).</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Change From Baseline in the TETRAS Upper Limb Total Score at Day 15</title>
          <description>The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change indicates improvement.</description>
          <population>The Efficacy Population consisted of all participants who completed at least 1 dose of study drug in the capsule formulation in Part C and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.82" spread="1.952"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.60" spread="2.436"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Day 15</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0278</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.53</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.628</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.87</ci_lower_limit>
            <ci_upper_limit>-0.19</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Change From Baseline in the TETRAS Upper Limb Individual Item (Performance Subscale Items 4a and 4b) Score at Day 15</title>
        <description>The TETRAS individual item score is the sum of the TETRAS Performance Subscale item 4a and 4b scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT) scores] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16, higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (Day 1) and Day 15</time_frame>
        <population>The Efficacy Population consisted of all participants who completed at least 1 dose of study drug in the capsule formulation in Part C and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening).</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Change From Baseline in the TETRAS Upper Limb Individual Item (Performance Subscale Items 4a and 4b) Score at Day 15</title>
          <description>The TETRAS individual item score is the sum of the TETRAS Performance Subscale item 4a and 4b scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral &quot;wing beating&quot; postural tremor (LWBPT) scores] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16, higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
          <population>The Efficacy Population consisted of all participants who completed at least 1 dose of study drug in the capsule formulation in Part C and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FOPT at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.79" spread="0.867"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in FOPT at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="1.060"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LWBPT at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.47" spread="0.695"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in LWBPT at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.80" spread="0.902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kinetic tremor at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.56" spread="0.726"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in Kinetic tremor at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.67" spread="0.838"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in Forward outstretched postural tremor (FOPT) at Day 15</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9579</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.258</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.57</ci_lower_limit>
            <ci_upper_limit>0.54</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in Lateral &quot;wing beating&quot; postural tremor (LWBPT) at Day 15</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0039</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.234</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.31</ci_lower_limit>
            <ci_upper_limit>-0.30</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in Kinetic tremor (KT) at Day 15</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0099</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.67</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.223</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.14</ci_lower_limit>
            <ci_upper_limit>-0.19</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Change From Baseline in TETRAS Performance Subscale (Items 6, 7, and 8) Scores at Day 15</title>
        <description>The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (Day 1) and Day 15</time_frame>
        <population>The Efficacy Population consisted of all participants who completed at least 1 dose of study drug in the capsule formulation in Part C and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening).</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Change From Baseline in TETRAS Performance Subscale (Items 6, 7, and 8) Scores at Day 15</title>
          <description>The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.</description>
          <population>The Efficacy Population consisted of all participants who completed at least 1 dose of study drug in the capsule formulation in Part C and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AS at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in AS at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Handwriting at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in Handwriting at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAT at Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.25" spread="0.640"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline in DAT at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.23" spread="0.594"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in Archimedes spirals (AS) at Day 15</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1595</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.5</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in Handwriting at Day 15</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0126</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in Dot approximation task (DAT) at Day 15</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1536</p_value>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.151</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.55</ci_lower_limit>
            <ci_upper_limit>0.10</ci_upper_limit>
            <estimate_desc>Least squares mean difference from Baseline (SAGE-217)</estimate_desc>
            <other_analysis_desc>MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A, B and C: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) or Serious Adverse Event (SAE)</title>
        <description>An Adverse Event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Adverse events that occurred after the first administration of study drug were denoted as TEAEs. A Serious Adverse Event (SAE) was an AE occurring during any study phase and at any dose of the study drug, comparator, or placebo, that fulfilled the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.</description>
        <time_frame>From first dose of study drug through 14 days after the last dose (Up to 28 days)</time_frame>
        <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Oral Solution</title>
            <description>Participants received SAGE-217 10 mg oral solution on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 with food in the morning.</description>
          </group>
          <group group_id="O2">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.</description>
          </group>
          <group group_id="O3">
            <title>Part B: Placebo</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
          <group group_id="O4">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
          <group group_id="O5">
            <title>Part C: SAGE-217 Capsules</title>
            <description>Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening).</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A, B and C: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) or Serious Adverse Event (SAE)</title>
          <description>An Adverse Event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Adverse events that occurred after the first administration of study drug were denoted as TEAEs. A Serious Adverse Event (SAE) was an AE occurring during any study phase and at any dose of the study drug, comparator, or placebo, that fulfilled the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.</description>
          <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Least One TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A, B and C: Number of Participants With Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score</title>
        <description>The C-SSRS consists of a baseline and post-baseline (PB) evaluation that assesses the lifetime experience of the participants with suicidal ideation and behavior. The data for suicidal ideation were summarized for participants who answered 'Yes'. Suicide ideation was categorized as 1) wish to be dead and 2) non-specific active suicidal thoughts.</description>
        <time_frame>Baseline and post-baseline (up to 28 days)</time_frame>
        <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Oral Solution</title>
            <description>Participants received SAGE-217 10 mg on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 as an oral solution with food in the morning.</description>
          </group>
          <group group_id="O2">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants in Part A received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.</description>
          </group>
          <group group_id="O3">
            <title>Part B: Placebo</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. Participants received placebo capsules to match their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
          <group group_id="O4">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who tolerated a ≥10 mg dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive SAGE-217 for 7 days beginning on Day 8 with food in the morning. Participants received their maximum tolerated SAGE-217 dose as determined in Part A.</description>
          </group>
          <group group_id="O5">
            <title>Part C: SAGE-217 Capsules</title>
            <description>Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A, B and C: Number of Participants With Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score</title>
          <description>The C-SSRS consists of a baseline and post-baseline (PB) evaluation that assesses the lifetime experience of the participants with suicidal ideation and behavior. The data for suicidal ideation were summarized for participants who answered 'Yes'. Suicide ideation was categorized as 1) wish to be dead and 2) non-specific active suicidal thoughts.</description>
          <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Wish to be Dead (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wish to be Dead (PB)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Specific Active Suicidal Thoughts (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Specific Active Suicidal Thoughts (PB)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Vital Signs</title>
        <description>Vital signs included heart rate, respiratory rate, temperature, and blood pressure.</description>
        <time_frame>Up to 28 days</time_frame>
        <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Oral Solution</title>
            <description>Participants received SAGE-217 10 mg on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 as an oral solution with food in the morning.</description>
          </group>
          <group group_id="O2">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants in Part A received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.</description>
          </group>
          <group group_id="O3">
            <title>Part B: Placebo</title>
            <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning.</description>
          </group>
          <group group_id="O4">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning.</description>
          </group>
          <group group_id="O5">
            <title>Part C: SAGE-217 Capsules</title>
            <description>Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Vital Signs</title>
          <description>Vital signs included heart rate, respiratory rate, temperature, and blood pressure.</description>
          <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Laboratory Parameters</title>
        <description>Laboratory parameters included hematology, blood chemistry, and urinalysis.</description>
        <time_frame>Up to 28 days</time_frame>
        <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Oral Solution</title>
            <description>Participants received SAGE-217 10 mg on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 as an oral solution with food in the morning.</description>
          </group>
          <group group_id="O2">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants in Part A received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.</description>
          </group>
          <group group_id="O3">
            <title>Part B: Placebo</title>
            <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning.</description>
          </group>
          <group group_id="O4">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning.</description>
          </group>
          <group group_id="O5">
            <title>Part C: SAGE-217 Capsules</title>
            <description>Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Laboratory Parameters</title>
          <description>Laboratory parameters included hematology, blood chemistry, and urinalysis.</description>
          <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Electrocardiogram (ECG) Values</title>
        <description>A 12-lead ECG was performed.</description>
        <time_frame>Up to 28 days</time_frame>
        <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Oral Solution</title>
            <description>Participants received SAGE-217 10 mg on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 as an oral solution with food in the morning.</description>
          </group>
          <group group_id="O2">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants in Part A received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.</description>
          </group>
          <group group_id="O3">
            <title>Part B: Placebo</title>
            <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning.</description>
          </group>
          <group group_id="O4">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning.</description>
          </group>
          <group group_id="O5">
            <title>Part C: SAGE-217 Capsules</title>
            <description>Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Electrocardiogram (ECG) Values</title>
          <description>A 12-lead ECG was performed.</description>
          <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A and B: Change From Baseline in Stanford Sleepiness Scale (SSS)</title>
        <description>The SSS was designed to quickly assess how alert a subject is feeling. Degrees of sleepiness and alertness are rated on a scale of 1 to 7, where the lowest score of 1 indicates the subject is &quot;feeling active, vital, alert, or wide awake&quot; and the highest score of 7 indicates the participant is &quot;no longer fighting sleep, sleep onset soon; having dream-like thoughts&quot;. Greater changes from baseline indicate greater sedation. A positive change from baseline indicates improvement.</description>
        <time_frame>Baseline (Day 1), Day 7 (predose) for Part A, Day 14 (predose) for Part B</time_frame>
        <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B). Number analyzed is the number of participants with data available for analysis at the given time point. SSS was not evaluated in Part C.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217</title>
            <description>Participants received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Change From Baseline in Stanford Sleepiness Scale (SSS)</title>
          <description>The SSS was designed to quickly assess how alert a subject is feeling. Degrees of sleepiness and alertness are rated on a scale of 1 to 7, where the lowest score of 1 indicates the subject is &quot;feeling active, vital, alert, or wide awake&quot; and the highest score of 7 indicates the participant is &quot;no longer fighting sleep, sleep onset soon; having dream-like thoughts&quot;. Greater changes from baseline indicate greater sedation. A positive change from baseline indicates improvement.</description>
          <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B). Number analyzed is the number of participants with data available for analysis at the given time point. SSS was not evaluated in Part C.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="1.41"/>
                    <measurement group_id="O2" value="1.5" spread="0.58"/>
                    <measurement group_id="O3" value="2.3" spread="1.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 7 or 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="1.42"/>
                    <measurement group_id="O2" value="-0.5" spread="0.58"/>
                    <measurement group_id="O3" value="-0.5" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A, B and C: Change From Baseline in Bond-Lader Visual Analogue Scale (VAS) Score</title>
        <description>Mood was assessed using the Bond-Lader VAS score. This is a 16-part self-administered questionnaire that employs a 100-mm VAS to explore different aspects of self-reported mood. Three factor scores for (alertness, contentedness, and calmness) were calculated using following equations based on normalized VAS scores:&#xD;
Alertness = 0.827X1 + 0.618X3 + 0.755X4 + 0.642X5 + 0.776X6 + 0.635X9 + 0.792X11 + 0.593X12 + 0.614X15;&#xD;
Contentedness = 0.677X7 + 0.697X8 + 0.823X13 + 0.738X14 + 0.594X16; and&#xD;
Calmness = 0.845X2 + 0.677X10,&#xD;
where Xi represents a subject's item score after normalization, and i represents the item number from the entire scale (in order from 1-16). A negative change from baseline (CFB) indicated more alertness, more contentedness, and more calmness.</description>
        <time_frame>Baseline (Day 1), Day 7 (predose) for Part A, Day 14 (predose) for Part B and Day 15 for Part C</time_frame>
        <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B). Number analyzed is the number of participants with data available for analysis at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning.</description>
          </group>
          <group group_id="O4">
            <title>Part C: SAGE-217 Capsules</title>
            <description>Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A, B and C: Change From Baseline in Bond-Lader Visual Analogue Scale (VAS) Score</title>
          <description>Mood was assessed using the Bond-Lader VAS score. This is a 16-part self-administered questionnaire that employs a 100-mm VAS to explore different aspects of self-reported mood. Three factor scores for (alertness, contentedness, and calmness) were calculated using following equations based on normalized VAS scores:&#xD;
Alertness = 0.827X1 + 0.618X3 + 0.755X4 + 0.642X5 + 0.776X6 + 0.635X9 + 0.792X11 + 0.593X12 + 0.614X15;&#xD;
Contentedness = 0.677X7 + 0.697X8 + 0.823X13 + 0.738X14 + 0.594X16; and&#xD;
Calmness = 0.845X2 + 0.677X10,&#xD;
where Xi represents a subject's item score after normalization, and i represents the item number from the entire scale (in order from 1-16). A negative change from baseline (CFB) indicated more alertness, more contentedness, and more calmness.</description>
          <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B). Number analyzed is the number of participants with data available for analysis at the given time point.</population>
          <units>log(units on a scale)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alertness: Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.737" spread="3.8640"/>
                    <measurement group_id="O2" value="18.345" spread="3.2388"/>
                    <measurement group_id="O3" value="21.308" spread="2.7694"/>
                    <measurement group_id="O4" value="18.1248" spread="4.62487"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alertness: CFB at Day 7, 14 or 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.148" spread="6.4794"/>
                    <measurement group_id="O2" value="-2.857" spread="1.6712"/>
                    <measurement group_id="O3" value="-1.038" spread="4.6404"/>
                    <measurement group_id="O4" value="1.3095" spread="5.87702"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Contentedness: Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.281" spread="2.7813"/>
                    <measurement group_id="O2" value="11.284" spread="0.2150"/>
                    <measurement group_id="O3" value="12.545" spread="1.7398"/>
                    <measurement group_id="O4" value="9.8911" spread="3.53165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Contentedness: CFB at Day 7, 14 or 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.121" spread="3.1249"/>
                    <measurement group_id="O2" value="-1.896" spread="2.2236"/>
                    <measurement group_id="O3" value="-0.471" spread="2.5222"/>
                    <measurement group_id="O4" value="0.0881" spread="3.16922"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calmness: Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.589" spread="1.2740"/>
                    <measurement group_id="O2" value="5.446" spread="0.7720"/>
                    <measurement group_id="O3" value="5.344" spread="0.7802"/>
                    <measurement group_id="O4" value="5.6157" spread="0.89826"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calmness: CFB at Day 7, 14 or 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.304" spread="1.4579"/>
                    <measurement group_id="O2" value="-0.613" spread="0.4106"/>
                    <measurement group_id="O3" value="-0.601" spread="1.4341"/>
                    <measurement group_id="O4" value="-0.5116" spread="1.23403"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A, B and C: Participant's Feeling After Taking the Study Drug as Assessed by Drug Effects Questionnaire (DEQ-5) Score</title>
        <description>Participants responded to 5 DEQs based on how they are feeling after taking the study drug. DEQ-5 were as follows; Q1: Do you FEEL a drug effect right now? Q2: Are you HIGH right now? Q3: Do you DISLIKE any of the effects that you are feeling right now? Q4: Do you LIKE any of the effects that you are feeling right now? Q5: Would you like MORE of the drug you took, right now? The answers were recorded on a 100-mm VAS, with the answer for each being &quot;Not at all&quot; (0 mm) and &quot;Extremely&quot; (100 mm) at the extremes. There were options to record &quot;Not applicable&quot; for questions 3 and 4 if no drug effects were felt and for question 5 prior to administration of study medication, and these participants were excluded from the data summarization. Higher score on Q1 indicates a drug effect; on Q2 indicates feeling high; on Q3 indicates disliking the drug; and on Q4 and Q5 indicates liking the drug.</description>
        <time_frame>Baseline (Day 1), Day 7 (2 hours postdose) for Part A, Day 14 (2 hours postdose) for Part B and Day 15 for Part C</time_frame>
        <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B). Number analyzed is the number of participants with data available for analysis at the given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 Capsules</title>
            <description>Participants received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE-217 Capsules</title>
            <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning.</description>
          </group>
          <group group_id="O4">
            <title>Part C: SAGE-217 Capsules</title>
            <description>Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A, B and C: Participant's Feeling After Taking the Study Drug as Assessed by Drug Effects Questionnaire (DEQ-5) Score</title>
          <description>Participants responded to 5 DEQs based on how they are feeling after taking the study drug. DEQ-5 were as follows; Q1: Do you FEEL a drug effect right now? Q2: Are you HIGH right now? Q3: Do you DISLIKE any of the effects that you are feeling right now? Q4: Do you LIKE any of the effects that you are feeling right now? Q5: Would you like MORE of the drug you took, right now? The answers were recorded on a 100-mm VAS, with the answer for each being &quot;Not at all&quot; (0 mm) and &quot;Extremely&quot; (100 mm) at the extremes. There were options to record &quot;Not applicable&quot; for questions 3 and 4 if no drug effects were felt and for question 5 prior to administration of study medication, and these participants were excluded from the data summarization. Higher score on Q1 indicates a drug effect; on Q2 indicates feeling high; on Q3 indicates disliking the drug; and on Q4 and Q5 indicates liking the drug.</description>
          <population>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B). Number analyzed is the number of participants with data available for analysis at the given time point.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Q1: Day 7, 14 or 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.8" spread="27.56"/>
                    <measurement group_id="O2" value="22.5" spread="18.84"/>
                    <measurement group_id="O3" value="33.0" spread="28.23"/>
                    <measurement group_id="O4" value="27.9" spread="24.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q2: Day 7, 14 or 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4" spread="22.56"/>
                    <measurement group_id="O2" value="18.0" spread="21.65"/>
                    <measurement group_id="O3" value="24.5" spread="21.44"/>
                    <measurement group_id="O4" value="13.3" spread="19.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q3: Day 7, 14 or 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.5" spread="30.63"/>
                    <measurement group_id="O2" value="12.0" spread="7.83"/>
                    <measurement group_id="O3" value="46.3" spread="24.85"/>
                    <measurement group_id="O4" value="35.2" spread="37.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q4: Day 7, 14 or 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0" spread="19.65"/>
                    <measurement group_id="O2" value="33.5" spread="32.25"/>
                    <measurement group_id="O3" value="33.0" spread="17.44"/>
                    <measurement group_id="O4" value="38.3" spread="32.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q5: Day 7, 14 or 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.5" spread="26.13"/>
                    <measurement group_id="O2" value="17.8" spread="18.61"/>
                    <measurement group_id="O3" value="23.0" spread="20.12"/>
                    <measurement group_id="O4" value="34.6" spread="31.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>TEAEs were collected from the first dose of study drug through 14 days after the last dose (up to 28 days).</time_frame>
      <desc>The Safety Population consisted of all participants who were administered at least 1 dose of open-label study drug (Parts A and C) or double-blind study drug (Part B).</desc>
      <group_list>
        <group group_id="E1">
          <title>Part A: SAGE-217 Oral Solution</title>
          <description>Participants received SAGE-217 10 mg on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 as an oral solution with food in the morning.</description>
        </group>
        <group group_id="E2">
          <title>Part A: SAGE-217 Capsules</title>
          <description>Participants in Part A received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.</description>
        </group>
        <group group_id="E3">
          <title>Part B: Placebo</title>
          <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning.</description>
        </group>
        <group group_id="E4">
          <title>Part B: SAGE-217 Capsules</title>
          <description>Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning.</description>
        </group>
        <group group_id="E5">
          <title>Part C: SAGE-217 Capsules</title>
          <description>Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Gastric infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Bradykinesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Muscle contractions involuntary</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Somnambulism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Nervousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Parts A and B were stopped early (in advance of the planned sample size).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Medical Monitor</name_or_title>
      <organization>Sage Therapeutics</organization>
      <phone>(617) 299-8380</phone>
      <email>info@sagerx.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02978781
org study id: 217-ETD-201
nct id: NCT02978781
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety,
      tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.
Part A of the study was an open-label design with morning dosing of SAGE-217 for 7 days and
      included 16 participants, 8 of whom qualified for, and entered, Part B.

      Part B had a double-blind, placebo-controlled, randomized withdrawal design with morning
      dosing for 7 days.

      Part C was an open-label design with morning and evening dosing for 14 days and included a
      different set of 18 participants.

      Parts A and B were stopped early (in advance of the planned sample size).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Part A: Change From Baseline in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 7
time frame: Baseline (Day 1) and Day 7 (8 hours postdose)
description: The accelerometer-based Kinesia kinetic tremor combined score is the sum of Kinesia kinetic tremor scores across both sides of the body. Tremor is measured using a motion sensor that transmits raw data to a computer where it converts the tremor amplitude to a Kinesia score of 0 to 4 based on validated algorithms; the total score ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.
measure: Part B: Change From Randomization in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 14
time frame: Randomization (Day 8, predose) and Day 14 (predose)
description: The accelerometer-based Kinesia kinetic tremor combined score is the sum of Kinesia kinetic tremor scores across both sides of the body. Tremor is measured using a motion sensor that transmits raw data to a computer where it converts the tremor amplitude to a Kinesia score of 0 to 4 based on validated algorithms; the total score ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.
measure: Part C: Change From Baseline in the Accelerometer-based Kinesia Upper Limb Tremor Combined Score at Day 15
time frame: Baseline (Day 1) and Day 15
description: The accelerometer-based Kinesia upper limb total score is the sum of the individual item scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral "wing beating" postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.
measure: Part A: Change From Baseline in Kinesia Upper Limb Total Score at Day 7
time frame: Baseline (Day 1) and Day 7 (8 hours postdose)
description: The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral "wing beating" postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.
measure: Part A: Change From Baseline in Kinesia Upper Limb Individual Item Score at Day 7
time frame: Baseline (Day 1) and Day 7 (8 hours [hr] postdose [pd])
description: The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral "wing beating" postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4, with higher scores indicating more tremors/greater tremor amplitude. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.
measure: Part A: Change From Baseline in the Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Total Score at Day 7
time frame: Baseline (Day 1) and Day 7 (8 hours postdose)
description: The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. The TETRAS individual item score included TETRAS Performance Subscale item 4a, 4b and 4c scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral "wing beating" postural tremor (LWBPT) scores and 4c: Kinetic tremor (KT) score] from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change indicates improvement.
measure: Change From Baseline in the TETRAS Upper Limb Individual Items (Performance Subscale Items 4a, 4b, or 4c) Scores at Day 7
time frame: Baseline (Day 1) and Day 7 (8 hours postdose)
description: The TETRAS individual item score is the sum of the TETRAS Performance Subscale items 4a, 4b, or 4c scores [4a: forward outstretched postural tremor (FOPT), 4b: lateral "wing beating" postural tremor (LWBPT), 4c: kinetic tremor] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16; higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.
measure: Part A: Change From Baseline in TETRAS Performance Subscale Score (Items 6, 7, and 8) at Day 7
time frame: Baseline (Day 1) and Day 7 (predose)
description: The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.
measure: Part B: Change From Randomization in the Kinesia Upper Limb Total Score at Day 14
time frame: Randomization (Day 8, predose) and Day 14 (predose)
description: The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral "wing beating" postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Randomization indicates improvement.
measure: Part B: Change From Randomization in the Kinesia Upper Limb Individual Item Score at Day 14
time frame: Randomization (Day 8, predose) and Day 14 (predose)
description: The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral "wing beating" postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Randomization indicates improvement.
measure: Part B: Change From Randomization in the TETRAS Upper Limb Total Score at Day 14
time frame: Randomization (Day 8, predose) and Day 14 (predose)
description: The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. The TETRAS individual item score included TETRAS Performance Subscale item 4a, 4b and 4c scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral "wing beating" postural tremor (LWBPT) scores and 4c: Kinetic tremor (KT) score] from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.
measure: Part B: Change From Randomization in the TETRAS Upper Limb Individual Item (Performance Subscale Items 4a and 4b) Score at Day 14
time frame: Randomization (Day 8, predose) and Day 14 (predose)
description: The TETRAS individual item score is the sum of the TETRAS Performance Subscale item 4a and 4b scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral "wing beating" postural tremor (LWBPT) scores] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.
measure: Part B: Change From Randomization in the TETRAS Performance Subscale Item 4c (Kinetic Tremor) Combined Score at Day 14
time frame: Randomization (Day 8, predose) and Day 14 (predose)
description: The TETRAS kinetic tremor combined score is the sum of the TETRAS Performance Subscale item 4c (kinetic tremor) scores from both sides of the body. The TETRAS kinetic tremor score ranges from 0 to 4, the total score for both sides of the body ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.
measure: Part B: Change From Baseline in TETRAS Performance Subscale (Items 6, 7, and 8) Score at Day 14
time frame: Baseline (Day 1) and Day 14 (predose)
description: The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.
measure: Part C: Change From Baseline in the Kinesia Upper Limb Individual Item Score at Day 15
time frame: Baseline (Day 1) and Day 15
description: The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral "wing beating" postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.
measure: Part C: Change From Baseline in the TETRAS Upper Limb Total Score at Day 15
time frame: Baseline (Day 1) and Day 15
description: The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change indicates improvement.
measure: Part C: Change From Baseline in the TETRAS Upper Limb Individual Item (Performance Subscale Items 4a and 4b) Score at Day 15
time frame: Baseline (Day 1) and Day 15
description: The TETRAS individual item score is the sum of the TETRAS Performance Subscale item 4a and 4b scores [4a: forward outstretched postural tremor (FOPT) and 4b: lateral "wing beating" postural tremor (LWBPT) scores] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16, higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.
measure: Part C: Change From Baseline in TETRAS Performance Subscale (Items 6, 7, and 8) Scores at Day 15
time frame: Baseline (Day 1) and Day 15
description: The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.
measure: Parts A, B and C: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) or Serious Adverse Event (SAE)
time frame: From first dose of study drug through 14 days after the last dose (Up to 28 days)
description: An Adverse Event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Adverse events that occurred after the first administration of study drug were denoted as TEAEs. A Serious Adverse Event (SAE) was an AE occurring during any study phase and at any dose of the study drug, comparator, or placebo, that fulfilled the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
measure: Part A, B and C: Number of Participants With Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score
time frame: Baseline and post-baseline (up to 28 days)
description: The C-SSRS consists of a baseline and post-baseline (PB) evaluation that assesses the lifetime experience of the participants with suicidal ideation and behavior. The data for suicidal ideation were summarized for participants who answered 'Yes'. Suicide ideation was categorized as 1) wish to be dead and 2) non-specific active suicidal thoughts.
measure: Number of Participants With Clinically Significant Vital Signs
time frame: Up to 28 days
description: Vital signs included heart rate, respiratory rate, temperature, and blood pressure.
measure: Number of Participants With Clinically Significant Laboratory Parameters
time frame: Up to 28 days
description: Laboratory parameters included hematology, blood chemistry, and urinalysis.
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Values
time frame: Up to 28 days
description: A 12-lead ECG was performed.
measure: Parts A and B: Change From Baseline in Stanford Sleepiness Scale (SSS)
time frame: Baseline (Day 1), Day 7 (predose) for Part A, Day 14 (predose) for Part B
description: The SSS was designed to quickly assess how alert a subject is feeling. Degrees of sleepiness and alertness are rated on a scale of 1 to 7, where the lowest score of 1 indicates the subject is "feeling active, vital, alert, or wide awake" and the highest score of 7 indicates the participant is "no longer fighting sleep, sleep onset soon; having dream-like thoughts". Greater changes from baseline indicate greater sedation. A positive change from baseline indicates improvement.
measure: Parts A, B and C: Change From Baseline in Bond-Lader Visual Analogue Scale (VAS) Score
time frame: Baseline (Day 1), Day 7 (predose) for Part A, Day 14 (predose) for Part B and Day 15 for Part C
description: Mood was assessed using the Bond-Lader VAS score. This is a 16-part self-administered questionnaire that employs a 100-mm VAS to explore different aspects of self-reported mood. Three factor scores for (alertness, contentedness, and calmness) were calculated using following equations based on normalized VAS scores:
Alertness = 0.827X1 + 0.618X3 + 0.755X4 + 0.642X5 + 0.776X6 + 0.635X9 + 0.792X11 + 0.593X12 + 0.614X15;
Contentedness = 0.677X7 + 0.697X8 + 0.823X13 + 0.738X14 + 0.594X16; and
Calmness = 0.845X2 + 0.677X10,
where Xi represents a subject's item score after normalization, and i represents the item number from the entire scale (in order from 1-16). A negative change from baseline (CFB) indicated more alertness, more contentedness, and more calmness.
measure: Parts A, B and C: Participant's Feeling After Taking the Study Drug as Assessed by Drug Effects Questionnaire (DEQ-5) Score
time frame: Baseline (Day 1), Day 7 (2 hours postdose) for Part A, Day 14 (2 hours postdose) for Part B and Day 15 for Part C
description: Participants responded to 5 DEQs based on how they are feeling after taking the study drug. DEQ-5 were as follows; Q1: Do you FEEL a drug effect right now? Q2: Are you HIGH right now? Q3: Do you DISLIKE any of the effects that you are feeling right now? Q4: Do you LIKE any of the effects that you are feeling right now? Q5: Would you like MORE of the drug you took, right now? The answers were recorded on a 100-mm VAS, with the answer for each being "Not at all" (0 mm) and "Extremely" (100 mm) at the extremes. There were options to record "Not applicable" for questions 3 and 4 if no drug effects were felt and for question 5 prior to administration of study medication, and these participants were excluded from the data summarization. Higher score on Q1 indicates a drug effect; on Q2 indicates feeling high; on Q3 indicates disliking the drug; and on Q4 and Q5 indicates liking the drug.
arm group label: Part A: SAGE-217 Oral Solution
arm group type: Experimental
description: Participants received SAGE-217 10 mg oral solution on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 with food in the morning.
arm group label: Part A: SAGE-217 Capsules
arm group type: Experimental
description: Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning.
arm group label: Part B: Placebo
arm group type: Placebo Comparator
description: Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning.
arm group label: Part B: SAGE-217 Capsules
arm group type: Experimental
description: Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning.
arm group label: Part C: SAGE-217 Capsules
arm group type: Experimental
description: Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening).
intervention type: Drug
intervention name: SAGE-217
description: SAGE-217 Oral Solution
arm group label: Part A: SAGE-217 Oral Solution
intervention type: Drug
intervention name: SAGE-217
description: SAGE-217 Capsules
arm group label: Part A: SAGE-217 Capsules
arm group label: Part B: SAGE-217 Capsules
arm group label: Part C: SAGE-217 Capsules
intervention type: Drug
intervention name: Placebo
description: SAGE-217 matching placebo capsules
arm group label: Part B: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Christopher Silber, MD
role: Study Director
affiliation: Sage Therapeutics
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country: United States
url: http://www.sagerx.com
description: Related Info
responsible party type: Sponsor
mesh term: Tremor
mesh term: Essential Tremor
sharing ipd: No
ipd description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Parts A and B were stopped early (in advance of the planned sample size).
point of contact: 