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

A Study to Evaluate the Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder

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

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Drug: Placebo oral capsule; Drug: NYX-783

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).

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35404
      • Aptinyx Clinical Site
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Aptinyx Clinical Site
  • Arkansas
    • Little Rock, Arkansas, United States, 30322
      • Aptinyx Clinical Site
  • California
    • 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
      • Aptinyx Clinical Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • Aptinyx Clinical Site
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Aptinyx Clinical Site
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Aptinyx Clinical Site
    • Lauderhill, Florida, United States, 33319
      • Aptinyx Clinical Site
    • Orlando, Florida, United States, 32801
      • Aptinyx Clinical Site
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Aptinyx
    • Atlanta, Georgia, United States, 30331
      • Aptinyx Clinical Site
  • Illinois
    • Hoffman Estates, Illinois, United States, 60619
      • Aptinyx Clinical Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Aptinyx Clinical Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Aptinyx Clinical Site
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Aptinyx Clinical Site
  • New York
    • 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
      • Aptinyx Clinical Site
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • Aptinyx Clinical Site
  • Ohio
    • Canton, Ohio, United States, 44720
      • Aptinyx Clinical Site
    • Cincinnati, Ohio, United States, 45219
      • Aptinyx Clinical Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73107
      • Aptinyx Clinical Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Aptinyx Clinical Site
  • Texas
    • Austin, Texas, United States, 78737
      • Aptinyx Clinical Site
    • San Antonio, Texas, United States, 78229
      • Aptinyx Clinical Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Aptinyx Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores	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.	Change from baseline to week 4 (Stage 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCL-5 (PTSD-Checklist for DSM-5)	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.	Change from baseline to week 4 (Stage 1)
PSQI (Pittsburgh Sleep Quality Index) Global Score	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.	Change from baseline to week 4 (Stage 1)
PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score	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.	Change from baseline to week 4 (Stage 1)
BAC (Brief Assessment of Cognition) Symbol Coding	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.	Change from baseline to week 4 (Stage 1)
CGI-S (Clinical Global Impression - Severity)	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).	Change from baseline to week 4 (Stage 1)
HADS-A (Hospital Anxiety and Depression Scale)	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.	From baseline to week 4 (Stage 1)

Collaborators and Investigators

• Sponsor: Aptinyx
• Collaborators: Massachusetts General Hospital; Premier Research Group plc

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): August 5, 2020
• Study Completion (Actual): August 5, 2020

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: NYX-783-2004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No