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Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT04044664
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
Premier Research Group plc
Massachusetts General Hospital
Information provided by (Responsible Party):
Aptinyx

Brief Summary:
To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic Stress Disorder population.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Drug: Placebo oral capsule Drug: NYX-783 Phase 2

Detailed Description:
The study will be a 10 to 12-week study, including a 1 to 3-week screening Period, followed by a double-blind, randomized, placebo-controlled, parallel-group Treatment Period, and a 1-week follow-up Period. Subjects eligible for the study will be randomized to receive either NYX-783 (4-weeks) or placebo (4 or 8-weeks).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to receive placebo or NYX-783.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
Actual Study Start Date : January 25, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo oral capsule
Matching placebo capsules.

Experimental: NYX-783 Low Dose Drug: NYX-783
NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

Experimental: NYX-783 High Dose Drug: NYX-783
NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).




Primary Outcome Measures :
  1. CAPS-5 (Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)) Total Score and Subscores [ Time Frame: From baseline to week 4 and Week 4 to Week 8 ]
    Change in CAPS-5 total score and Subscores


Secondary Outcome Measures :
  1. PCL-5 (PTSD-Checklist for DSM-5) [ Time Frame: From baseline to week 4 and Week 4 to Week 8 ]
    Assess the effect of NYX-783 compared to placebo in changes of symptoms as measured by PCL-5

  2. PSQI (Pittsburgh Sleep Quality Index) Global Score [ Time Frame: From baseline to week 4 and Week 4 to Week 8 ]
    Assess the effects of NYX-783 compared to placebo in changes in sleep quality as measure by the PSQI Global Score

  3. PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score [ Time Frame: From baseline to week 4 and Week 4 to Week 8 ]
    Assess the effects of NYX-783 compared to placebo in changes in sleep quality as measure by the PSQI-A Global Score

  4. BAC Symbol Coding (Brief Assessment of Cognition) [ Time Frame: From baseline to week 4 and Week 4 to Week 8 ]
    Assess the effect of NYX-783 compared to placebo in changes in cognitive function as measured by the BAC Symbol Coding

  5. CGI-S (Clinical Global Impression - Severity) [ Time Frame: From baseline to week 4 and Week 4 to Week 8 ]
    Assess the effect of NYX-783 compared to placebo in the change in global clinical severity of PTSD symptoms as measured by the CGI-S

  6. HADS (Hospital Anxiety and Depression Scale) [ Time Frame: From baseline to week 4 and Week 4 to Week 8 ]
    Compare NYX-783 vs. placebo in the changes in levels of anxiety and depression as measured by the HADS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A primary diagnosis of PTSD (DSM-5 criteria, APA 2013) with the primary traumatic event occurring ≥12 months prior to screening.
  • PCL-5 ≥38 at screening.
  • CAPS-5 total score ≥30 at screening.

Exclusion Criteria:

  • Complex PTSD.
  • Trauma focused psychotherapies.
  • Primary traumatic event occurred prior to 2001.
  • Primary traumatic event was followed by further major traumatic life episodes.
  • Other psychiatric disorders that is the primary focus of treatment or followed/worsened since exposure to the trauma (except for major depressive disorder or anxiety disorders that followed exposure to the trauma or an anxiety disorder that showed a worsening after trauma)
  • Current use of medications with primarily central nervous system activities
  • Other clinically significant medical histories that may interfere with completing the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044664


Contacts
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Contact: Ferenc Martenyi, MD, PhD 847-871-0377 ext 1 clinicalstudies@aptinyx.com
Contact: Kerrin Young, BS 847-871-0377 ext 1

Locations
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United States, Arizona
Aptinyx Clinical Site Recruiting
Phoenix, Arizona, United States, 85012
United States, Arkansas
Aptinyx Clinical Site Recruiting
Little Rock, Arkansas, United States, 30322
United States, California
Aptinyx Clinical Site Recruiting
Glendale, California, United States, 91206
Aptinyx Clinical Site Recruiting
Oakland, California, United States, 94607
Aptinyx Clinical Site Recruiting
Oceanside, California, United States, 92056
Aptinyx Clinical Site Recruiting
Orange, California, United States, 92868
Aptinyx Clinical Site Recruiting
Riverside, California, United States, 92503
Aptinyx Clinical Site Recruiting
San Diego, California, United States, 92103
Aptinyx Clinical Site Recruiting
San Marcos, California, United States, 92078
Aptinyx Clinical Site Recruiting
Torrance, California, United States, 90502
United States, Colorado
Aptinyx Clinical Site Recruiting
Colorado Springs, Colorado, United States, 80910
United States, Florida
Aptinyx Clinical Site Recruiting
Jacksonville, Florida, United States, 32256
Aptinyx Clinical Site Recruiting
Lauderhill, Florida, United States, 33319
Aptinyx Clinical Site Recruiting
Orlando, Florida, United States, 32801
United States, Massachusetts
Aptinyx Clinical Site Recruiting
Boston, Massachusetts, United States, 02131
United States, Nevada
Aptinyx Clinical Site Recruiting
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Aptinyx Clinical Site Recruiting
Berlin, New Jersey, United States, 08009
United States, New York
Aptinyx Clinical Site Recruiting
Cedarhurst, New York, United States, 11516
Aptinyx Clinical Site Recruiting
Staten Island, New York, United States, 10312
United States, Ohio
Aptinyx Clinical Site Recruiting
Canton, Ohio, United States, 44720
United States, Tennessee
Aptinyx Clinical Site Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Aptinyx Clinical Site Recruiting
San Antonio, Texas, United States, 78229
United States, Washington
Aptinyx Clinical Site Recruiting
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Aptinyx
Premier Research Group plc
Massachusetts General Hospital

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Responsible Party: Aptinyx
ClinicalTrials.gov Identifier: NCT04044664     History of Changes
Other Study ID Numbers: NYX-783-2004
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders