<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/NCT03284931</url>
  </required_header>
  <id_info>
    <org_study_id>217-EXM-101</org_study_id>
    <nct_id>NCT03284931</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model</brief_title>
  <official_title>A Randomized, Double-Blind, Multiple Dose, 3-way Crossover, Exploratory Study to Assess the Pharmacodynamic Effects of SAGE-217 Capsules in Healthy Adults Using a 5-hour Phase Advance Model of Insomnia</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 will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy&#xD;
      adult subjects using an insomnia model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects are expected to complete Treatment Periods 1, 2 and 3, followed by an optional&#xD;
      open-label administration of SAGE-217 for pharmacokinetic purposes (Treatment Period 4).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Actual">December 18, 2017</completion_date>
  <primary_completion_date type="Actual">December 4, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep efficiency, as determined by polysomnography (PSG)</measure>
    <time_frame>16 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability, as assessed by adverse events</measure>
    <time_frame>36 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability, as assessed by vital signs</measure>
    <time_frame>29 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability, as assessed by clinical laboratory data</measure>
    <time_frame>29 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability, as assessed by ECG</measure>
    <time_frame>29 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>29 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>SAGE-217 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAGE-217</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAGE-217 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAGE-217</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAGE-217 high dose</intervention_name>
    <description>high dose</description>
    <arm_group_label>SAGE-217 high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAGE-217 low dose</intervention_name>
    <description>low dose</description>
    <arm_group_label>SAGE-217 low dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is willing and able to participate in the study, including all assessments,&#xD;
             planned inpatient stays and all follow-up visits&#xD;
&#xD;
          -  Subject is a healthy, ambulatory volunteer&#xD;
&#xD;
          -  Subject meets sleep Qualification criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a medical history of suicidal behavior, epilepsy, eating disorders, sleep&#xD;
             disorders, or circadian rhythm disorders&#xD;
&#xD;
          -  Subject has worked a night shift or flown &gt;1 time zone within 30 days prior to&#xD;
             Screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jim Doherty, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Sage Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>January 17, 2018</last_update_submitted>
  <last_update_submitted_qc>January 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03284931
org study id: 217-EXM-101
nct id: NCT03284931
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy
      adult subjects using an insomnia model.
Subjects are expected to complete Treatment Periods 1, 2 and 3, followed by an optional
      open-label administration of SAGE-217 for pharmacokinetic purposes (Treatment Period 4).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Sleep efficiency, as determined by polysomnography (PSG)
time frame: 16 days
measure: Safety and tolerability, as assessed by adverse events
time frame: 36 days
measure: Safety and tolerability, as assessed by vital signs
time frame: 29 days
measure: Safety and tolerability, as assessed by clinical laboratory data
time frame: 29 days
measure: Safety and tolerability, as assessed by ECG
time frame: 29 days
measure: Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: 29 days
arm group label: SAGE-217 high dose
arm group type: Experimental
description: SAGE-217
arm group label: SAGE-217 low dose
arm group type: Experimental
description: SAGE-217
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: SAGE-217 high dose
description: high dose
arm group label: SAGE-217 high dose
intervention type: Drug
intervention name: Placebo
description: placebo
arm group label: Placebo
intervention type: Drug
intervention name: SAGE-217 low dose
description: low dose
arm group label: SAGE-217 low dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jim Doherty, PhD
role: Study Director
affiliation: Sage Therapeutics
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No