Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: PTSD

In brief

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)

Key facts

Study ID

NCT05181995

Run by

Aptinyx

People needed

121

Starts

2021-12-13

Expected to finish

2023-03-30

Last updated by the study team

2023-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Aptinyx Clinical Site — Tuscaloosa, Alabama, United States
• Aptinyx Clinical Site — Phoenix, Arizona, United States
• Aptinyx Clinical Site — Bentonville, Arkansas, United States
• Aptinyx Clinical Site — Bellflower, California, United States
• Aptinyx Clinical Site — Glendale, California, United States
• Aptinyx Clinical Site — La Jolla, California, United States
• Aptinyx Clinical Site — Oceanside, California, United States
• Aptinyx Clinical Site — Riverside, California, United States
• Aptinyx Clinical Site — Santa Ana, California, United States
• Aptinyx Clinical Site — Temecula, California, United States
• Aptinyx Clinical Site — Torrance, California, United States
• Aptinyx Clinical Site — Colorado Springs, Colorado, United States
• Aptinyx Clinical Site — Denver, Colorado, United States
• Aptinyx Clinical Site — Hialeah, Florida, United States
• Aptinyx Clinical Site — Hollywood, Florida, United States
• Aptinyx Clinical Site — Jacksonville, Florida, United States
• Aptinyx Clinical Site — Jupiter, Florida, United States
• Aptinyx Clinical Site — Miami, Florida, United States
• Aptinyx Clinical Site — Miami, Florida, United States
• Aptinyx Clinical Site — Miami Lakes, Florida, United States
• Aptinyx Clinical Site — Okeechobee, Florida, United States
• Aptinyx Clinical Site — Orlando, Florida, United States
• Aptinyx Clinical Site — Atlanta, Georgia, United States
• Aptinyx Clinical Site — Boston, Massachusetts, United States
• Aptinyx Clinical Site — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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