We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04044664
Recruitment Status : Completed
First Posted : August 5, 2019
Results First Posted : May 13, 2022
Last Update Posted : May 17, 2022
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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 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
Actual Primary Completion Date : August 5, 2020
Actual Study Completion Date : August 5, 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 (10 mg QD) Drug: NYX-783
NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

Experimental: NYX-783 High Dose (50 mg QD) 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: Change from baseline to week 4 (Stage 1) ]
    CAPS-5 [Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] is a structured interview for diagnosis and assessment of PTSD. The assessor combines information about frequency and intensity of an item into a severity rating (0-4). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: intrusions (items 1-5, minimum score 0, maximum score 20), avoidance (items 6-7, minimum score 0, maximum score 8), negative alterations in cognitions and mood (items 8-14, minimum score 0, maximum score 28), and alterations in arousal and reactivity (items 15-20, minimum score 0, maximum score 24). CAPS-5 Total Scores range from 0 to 80. A higher score corresponds to more severe PTSD.


Secondary Outcome Measures :
  1. PCL-5 (PTSD-Checklist for DSM-5) [ Time Frame: Change from baseline to week 4 (Stage 1) ]
    Assess the effect of NYX-783 compared to placebo in changes of symptoms as measured by PCL-5. The PCL-5 ranges from 0 to 80; a higher score corresponds to more severe PTSD.

  2. PSQI (Pittsburgh Sleep Quality Index) Global Score [ Time Frame: Change from baseline to week 4 (Stage 1) ]
    Assess the effects of NYX-783 compared to placebo in changes in sleep quality as measure by the PSQI Global Score. The PSQI is a questionnaire to assess sleep quality and disturbances. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score >5 indicates significant sleep disturbance.

  3. PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score [ Time Frame: Change from baseline to week 4 (Stage 1) ]
    Assess the effects of NYX-783 compared to placebo in changes in sleep quality as measure by the PSQI-A Global Score. The PSQI-A score ranges from 0-21; lower scores represent less disruptive behavior.

  4. BAC (Brief Assessment of Cognition) Symbol Coding [ Time Frame: Change from baseline to week 4 (Stage 1) ]
    Assess the effect of NYX-783 compared to placebo in changes in cognitive function as measured by the BAC Symbol Coding. BAC symbol coding score is a count which ranges from 0 to 110; higher scores represent higher function.

  5. CGI-S (Clinical Global Impression - Severity) [ Time Frame: Change from baseline to week 4 (Stage 1) ]
    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. The Clinical Global Impressions-Severity (CGI-S) score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects).

  6. HADS-A (Hospital Anxiety and Depression Scale) [ Time Frame: From baseline to week 4 (Stage 1) ]
    The HADS is a self-assessment tool consisting of two subscales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a Depression score (HADS-D), or can be added to produce a total score (HADS-T). Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0-42 and sub scores for anxiety or depression ranging from 0-21 for each subscale. Higher scores represent more severe anxiety or depression. HADS-A is presented here.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 [Post Traumatic Stress Disorder, according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders)] with the primary traumatic event occurring ≥12 months prior to screening.
  • PCL-5 (PTSD Checklist for DSM-5) ≥38 at screening.
  • CAPS-5 (Clinician-Administered PTSD Scale for DSM-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


Locations
Layout table for location information
United States, Alabama
Aptinyx Clinical Site
Tuscaloosa, Alabama, United States, 35404
United States, Arizona
Aptinyx Clinical Site
Phoenix, Arizona, United States, 85012
United States, Arkansas
Aptinyx Clinical Site
Little Rock, Arkansas, United States, 30322
United States, California
Aptinyx Clinical Site
Bellflower, California, United States, 90706
Aptinyx Clinical Site
Glendale, California, United States, 91206
Aptinyx Clinical Site
Imperial, California, United States, 92251
Aptinyx Clinical Site
Oakland, California, United States, 94607
Aptinyx Clinical Site
Oceanside, California, United States, 92056
Aptinyx Clinical Site
Orange, California, United States, 92868
Aptinyx Clinical Site
Riverside, California, United States, 92503
Aptinyx Clinical Site
San Diego, California, United States, 92103
Aptinyx Clinical Site
San Marcos, California, United States, 92078
Aptinyx Clinical Site
Santa Ana, California, United States, 92705
Aptinyx Clinical Site
Temecula, California, United States, 32591
Aptinyx Clinical Site
Torrance, California, United States, 90502
United States, Colorado
Aptinyx Clinical Site
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Aptinyx Clinical Site
Norwich, Connecticut, United States, 06360
United States, Florida
Aptinyx Clinical Site
Jacksonville, Florida, United States, 32256
Aptinyx Clinical Site
Lauderhill, Florida, United States, 33319
Aptinyx Clinical Site
Orlando, Florida, United States, 32801
United States, Georgia
Aptinyx
Atlanta, Georgia, United States, 30329
Aptinyx Clinical Site
Atlanta, Georgia, United States, 30331
United States, Illinois
Aptinyx Clinical Site
Hoffman Estates, Illinois, United States, 60619
United States, Massachusetts
Aptinyx Clinical Site
Boston, Massachusetts, United States, 02131
United States, Nevada
Aptinyx Clinical Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Aptinyx Clinical Site
Berlin, New Jersey, United States, 08009
United States, New York
Aptinyx Clinical Site
Cedarhurst, New York, United States, 11516
Aptinyx Clinical Site
New York, New York, United States, 10036
Aptinyx Clinical Site
Staten Island, New York, United States, 10312
United States, North Carolina
Aptinyx Clinical Site
Salisbury, North Carolina, United States, 28144
United States, Ohio
Aptinyx Clinical Site
Canton, Ohio, United States, 44720
Aptinyx Clinical Site
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Aptinyx Clinical Site
Oklahoma City, Oklahoma, United States, 73107
United States, Tennessee
Aptinyx Clinical Site
Memphis, Tennessee, United States, 38119
United States, Texas
Aptinyx Clinical Site
Austin, Texas, United States, 78737
Aptinyx Clinical Site
San Antonio, Texas, United States, 78229
United States, Washington
Aptinyx Clinical Site
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Aptinyx
Premier Research Group plc
Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Aptinyx:
Study Protocol  [PDF] May 1, 2020
Statistical Analysis Plan  [PDF] September 18, 2020

Layout table for additonal information
Responsible Party: Aptinyx
ClinicalTrials.gov Identifier: NCT04044664    
Other Study ID Numbers: NYX-783-2004
First Posted: August 5, 2019    Key Record Dates
Results First Posted: May 13, 2022
Last Update Posted: May 17, 2022
Last Verified: May 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders