Status:
TERMINATED
Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD
Lead Sponsor:
Aptinyx
Collaborating Sponsors:
Worldwide Clinical Trials
Conditions:
PTSD
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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)
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT05181995
Start Date
December 13 2021
End Date
March 30 2023
Last Update
April 7 2023
Active Locations (37)
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1
Aptinyx Clinical Site
Tuscaloosa, Alabama, United States, 35404
2
Aptinyx Clinical Site
Phoenix, Arizona, United States, 85012
3
Aptinyx Clinical Site
Bentonville, Arkansas, United States, 72712
4
Aptinyx Clinical Site
Bellflower, California, United States, 90706