Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD
- Registration Number
- NCT05181995
- Lead Sponsor
- Aptinyx
- Brief Summary
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants with Post-Traumatic Stress Disorder (PTSD)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 121
Inclusion Criteria
- PTSD (DSM-5 criteria)
- Stable allowed medications with no planned changes from 30 days prior to screening through study participation
- Willing to use highly effective birth control
- Willing to comply with protocol visits and procedures
Exclusion Criteria
- Moderate to severe traumatic brain injury
- Other psychiatric disorders (based on SCID-5-CT) or neurodegenerative disorders
- Substance use disorder or alcohol use disorder within 6 months prior to screening
- Psychotherapy or cognitive based therapy within 30 days prior to screening
- Use of investigational drug within 30 days prior to screening
- Prior participation in study of NYX-783, NYX-2925 or NYX-458.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 50 mg NYX-783 QD NYX-783 50 mg NYX-783 QD Placebo Placebo Placebo QD
- Primary Outcome Measures
Name Time Method CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition) study endpoint, up to 10 weeks Change from Baseline in CAPS-5
- Secondary Outcome Measures
Name Time Method CGI-S (Clinician Global Impression - Severity) study endpoint, up to 10 weeks Change from Baseline in CGI-S
SDS (Sheehan Disability Scale) study endpoint, up to 10 weeks Change from Baseline in SDS
PGI-S (Patient Global Impression - Severity) study endpoint, up to 10 weeks Change from Baseline in PGI-S
Trial Locations
- Locations (1)
Aptinyx Clinical Site
🇺🇸Plano, Texas, United States