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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044664
• Other study ID #: NYX-783-2004
• Status: Completed
• Phase: Phase 2
• Start date: January 25, 2019
• Est. completion date: August 5, 2020

Study information

• Verified date: May 2022
• Source: Aptinyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Placebo oral capsule
Matching placebo capsules.
• NYX-783
NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

Locations

Country	Name	City	State
United States	Aptinyx	Atlanta	Georgia
United States	Aptinyx Clinical Site	Atlanta	Georgia
United States	Aptinyx Clinical Site	Austin	Texas
United States	Aptinyx Clinical Site	Bellevue	Washington
United States	Aptinyx Clinical Site	Bellflower	California
United States	Aptinyx Clinical Site	Berlin	New Jersey
United States	Aptinyx Clinical Site	Boston	Massachusetts
United States	Aptinyx Clinical Site	Canton	Ohio
United States	Aptinyx Clinical Site	Cedarhurst	New York
United States	Aptinyx Clinical Site	Cincinnati	Ohio
United States	Aptinyx Clinical Site	Colorado Springs	Colorado
United States	Aptinyx Clinical Site	Glendale	California
United States	Aptinyx Clinical Site	Hoffman Estates	Illinois
United States	Aptinyx Clinical Site	Imperial	California
United States	Aptinyx Clinical Site	Jacksonville	Florida
United States	Aptinyx Clinical Site	Las Vegas	Nevada
United States	Aptinyx Clinical Site	Lauderhill	Florida
United States	Aptinyx Clinical Site	Little Rock	Arkansas
United States	Aptinyx Clinical Site	Memphis	Tennessee
United States	Aptinyx Clinical Site	New York	New York
United States	Aptinyx Clinical Site	Norwich	Connecticut
United States	Aptinyx Clinical Site	Oakland	California
United States	Aptinyx Clinical Site	Oceanside	California
United States	Aptinyx Clinical Site	Oklahoma City	Oklahoma
United States	Aptinyx Clinical Site	Orange	California
United States	Aptinyx Clinical Site	Orlando	Florida
United States	Aptinyx Clinical Site	Phoenix	Arizona
United States	Aptinyx Clinical Site	Riverside	California
United States	Aptinyx Clinical Site	Salisbury	North Carolina
United States	Aptinyx Clinical Site	San Antonio	Texas
United States	Aptinyx Clinical Site	San Diego	California
United States	Aptinyx Clinical Site	San Marcos	California
United States	Aptinyx Clinical Site	Santa Ana	California
United States	Aptinyx Clinical Site	Staten Island	New York
United States	Aptinyx Clinical Site	Temecula	California
United States	Aptinyx Clinical Site	Torrance	California
United States	Aptinyx Clinical Site	Tuscaloosa	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
Aptinyx	Massachusetts General Hospital, Premier Research Group plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)