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

• Status: Completed
• Trial end date: 2020-08-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• A primary diagnosis of PTSD (DSM-5 criteria, APA 2013) with the primary traumatic event occurring ≥12 months prior to screening.

• PCL-5 ≥38 at screening.

• CAPS-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.