<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/NCT03787758</url>
  </required_header>
  <id_info>
    <org_study_id>718-CLP-102 B</org_study_id>
    <nct_id>NCT03787758</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B</brief_title>
  <official_title>A Phase 1, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Healthy Adults With an Open-label Cohort of Patients With Huntington's Disease</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 phase 1, double-blind, placebo-controlled, multiple ascending dose study to&#xD;
      determine the safety, tolerability, and pharmacokinetics of SAGE-718 oral solution in healthy&#xD;
      adults (Part A) with an open-label cohort of patients with Huntington's disease (Part B)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This posting addresses Part B&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2019</start_date>
  <completion_date type="Actual">October 7, 2019</completion_date>
  <primary_completion_date type="Actual">October 7, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.</measure>
    <time_frame>21 Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with change from baseline in vital signs.</measure>
    <time_frame>21 Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities</measure>
    <time_frame>21 Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with change from baseline in clinical laboratory parameters.</measure>
    <time_frame>21 Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS).</measure>
    <time_frame>21 Days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by area under the curve [AUC].</measure>
    <time_frame>17 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by maximum observed concentration [Cmax].</measure>
    <time_frame>17 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by time of occurrence of Cmax [tmax].</measure>
    <time_frame>17 Days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Huntington Disease</condition>
  <arm_group>
    <arm_group_label>SAGE-718</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAGE-718</intervention_name>
    <description>SAGE-718</description>
    <arm_group_label>SAGE-718</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is positive for mutant HTT (documented CAG repeats ≥ 40 units).&#xD;
&#xD;
          2. Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at&#xD;
             screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has any clinically significant abnormal finding on the physical exam at&#xD;
             screening or admission.&#xD;
&#xD;
          2. Subject has a history or presence of a neurologic disease or condition (other than&#xD;
             Huntington's disease), including but not limited to severe chorea, epilepsy, closed&#xD;
             head trauma with clinically significant sequelae, or a prior seizure.&#xD;
&#xD;
          3. Subject has a family history of epilepsy.&#xD;
&#xD;
          4. Subject has a positive screening test for alcohol or drugs of abuse (including&#xD;
             marijuana) at screening or admission.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_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 31, 2022</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>Huntington Disease</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>
  <!-- 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/NCT03787758
org study id: 718-CLP-102 B
nct id: NCT03787758
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is a phase 1, double-blind, placebo-controlled, multiple ascending dose study to
      determine the safety, tolerability, and pharmacokinetics of SAGE-718 oral solution in healthy
      adults (Part A) with an open-label cohort of patients with Huntington's disease (Part B)
This posting addresses Part B
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.
time frame: 21 Days
measure: Percentage of participants with change from baseline in vital signs.
time frame: 21 Days
measure: Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities
time frame: 21 Days
measure: Percentage of participants with change from baseline in clinical laboratory parameters.
time frame: 21 Days
measure: Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS).
time frame: 21 Days
measure: PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by area under the curve [AUC].
time frame: 17 Days
measure: PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by maximum observed concentration [Cmax].
time frame: 17 Days
measure: PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by time of occurrence of Cmax [tmax].
time frame: 17 Days
arm group label: SAGE-718
arm group type: Experimental
intervention type: Drug
intervention name: SAGE-718
description: SAGE-718
arm group label: SAGE-718
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Huntington Disease
sharing ipd: No
ipd description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.