Study Stopped
company decision
Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD
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)
1 other identifier
interventional
121
1 country
37
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2021
Shorter than P25 for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2021
CompletedFirst Submitted
Initial submission to the registry
December 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedApril 7, 2023
April 1, 2023
1.3 years
December 15, 2021
April 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition)
Change from Baseline in CAPS-5
study endpoint, up to 10 weeks
Secondary Outcomes (3)
CGI-S (Clinician Global Impression - Severity)
study endpoint, up to 10 weeks
PGI-S (Patient Global Impression - Severity)
study endpoint, up to 10 weeks
SDS (Sheehan Disability Scale)
study endpoint, up to 10 weeks
Study Arms (2)
50 mg NYX-783 QD
EXPERIMENTAL50 mg NYX-783 QD
Placebo
PLACEBO COMPARATORPlacebo QD
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aptinyxlead
- Worldwide Clinical Trialscollaborator
Study Sites (37)
Aptinyx Clinical Site
Tuscaloosa, Alabama, 35404, United States
Aptinyx Clinical Site
Phoenix, Arizona, 85012, United States
Aptinyx Clinical Site
Bentonville, Arkansas, 72712, United States
Aptinyx Clinical Site
Bellflower, California, 90706, United States
Aptinyx Clinical Site
Glendale, California, 91206, United States
Aptinyx Clinical Site
La Jolla, California, 92037, United States
Aptinyx Clinical Site
Oceanside, California, 92056, United States
Aptinyx Clinical Site
Riverside, California, 92506, United States
Aptinyx Clinical Site
Santa Ana, California, 92705, United States
Aptinyx Clinical Site
Temecula, California, 92591, United States
Aptinyx Clinical Site
Torrance, California, 90502, United States
Aptinyx Clinical Site
Colorado Springs, Colorado, 80910, United States
Aptinyx Clinical Site
Denver, Colorado, 80209, United States
Aptinyx Clinical Site
Hialeah, Florida, 33012, United States
Aptinyx Clinical Site
Hollywood, Florida, 33020, United States
Aptinyx Clinical Site
Jacksonville, Florida, 32256, United States
Aptinyx Clinical Site
Jupiter, Florida, 33458, United States
Aptinyx Clinical Site
Miami, Florida, 33125, United States
Aptinyx Clinical Site
Miami, Florida, 33174, United States
Aptinyx Clinical Site
Miami Lakes, Florida, 33014, United States
Aptinyx Clinical Site
Okeechobee, Florida, 34972, United States
Aptinyx Clinical Site
Orlando, Florida, 32801, United States
Aptinyx Clinical Site
Atlanta, Georgia, 30331, United States
Aptinyx Clinical Site
Boston, Massachusetts, 02131, United States
Aptinyx Clinical Site
Las Vegas, Nevada, 89102, United States
Aptinyx Clinical Site
Albuquerque, New Mexico, 87102, United States
Aptinyx Clinical Site
New York, New York, 10036, United States
Aptinyx Clinical Site
Cincinnati, Ohio, 45219, United States
Aptinyx Clinical Site
Dayton, Ohio, 45432, United States
Aptinyx Clinical Site
Kettering, Ohio, 45439, United States
Aptinyx Clinical Site
North Canton, Ohio, 44720, United States
Aptinyx Clinical Site
Media, Pennsylvania, 19063, United States
Aptinyx Clinical Site
Memphis, Tennessee, 38119, United States
Aptinyx Clinical Site
Austin, Texas, 78737, United States
Aptinyx Clinical Site
Fort Worth, Texas, 76104, United States
Aptinyx Clinical Site
Houston, Texas, 77090, United States
Aptinyx Clinical Site
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2021
First Posted
January 10, 2022
Study Start
December 13, 2021
Primary Completion
March 30, 2023
Study Completion
March 30, 2023
Last Updated
April 7, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share