Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD
Sponsor
Aptinyx (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05181995
Collaborator
Worldwide Clinical Trials (Other)
300
30
2
23.6
10
0.4
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date
:
Dec 13, 2021
Anticipated Primary Completion Date
:
Dec 1, 2023
Anticipated Study Completion Date
:
Dec 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 50 mg NYX-783 QD 50 mg NYX-783 QD |
Drug: NYX-783
NYX-783
|
| Placebo Comparator: Placebo Placebo QD |
Drug: Placebo
Placebo for 50 mg NYX-783
|
Outcome Measures
Primary Outcome Measures
- 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
- CGI-S (Clinician Global Impression - Severity) [study endpoint, up to 10 weeks]
Change from Baseline in CGI-S
- PGI-S (Patient Global Impression - Severity) [study endpoint, up to 10 weeks]
Change from Baseline in PGI-S
- SDS (Sheehan Disability Scale) [study endpoint, up to 10 weeks]
Change from Baseline in SDS
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
| 5 | Aptinyx Clinical Site | Glendale | California | United States | 91206 |
| 6 | Aptinyx Clinical Site | Oceanside | California | United States | 92056 |
| 7 | Aptinyx Clinical Site | Riverside | California | United States | 92506 |
| 8 | Aptinyx Clinical Site | Santa Ana | California | United States | 92705 |
| 9 | Aptinyx Clinical Site | Temecula | California | United States | 92591 |
| 10 | Aptinyx Clinical Site | Torrance | California | United States | 90502 |
| 11 | Aptinyx Clinical Site | Colorado Springs | Colorado | United States | 80910 |
| 12 | Aptinyx Clinical Site | Denver | Colorado | United States | 80209 |
| 13 | Aptinyx Clinical Site | Hialeah | Florida | United States | 33012 |
| 14 | Aptinyx Clinical Site | Jacksonville | Florida | United States | 32256 |
| 15 | Aptinyx Clinical Site | Miami Lakes | Florida | United States | 33014 |
| 16 | Aptinyx Clinical Site | Miami | Florida | United States | 33125 |
| 17 | Aptinyx Clinical Site | Okeechobee | Florida | United States | 34972 |
| 18 | Aptinyx Clinical Site | Orlando | Florida | United States | 32801 |
| 19 | Aptinyx Clinical Site | Atlanta | Georgia | United States | 30331 |
| 20 | Aptinyx Clinical Site | Boston | Massachusetts | United States | 02131 |
| 21 | Aptinyx Clinical Site | Las Vegas | Nevada | United States | 89102 |
| 22 | Aptinyx Clinical Site | New York | New York | United States | 10036 |
| 23 | Aptinyx Clinical Site | Cincinnati | Ohio | United States | 45221 |
| 24 | Aptinyx Clinical Site | Kettering | Ohio | United States | 45439 |
| 25 | Aptinyx Clinical Site | North Canton | Ohio | United States | 44720 |
| 26 | Aptinyx Clinical Site | Media | Pennsylvania | United States | 19063 |
| 27 | Aptinyx Clinical Site | Memphis | Tennessee | United States | 38119 |
| 28 | Aptinyx Clinical Site | Austin | Texas | United States | 78737 |
| 29 | Aptinyx Clinical Site | Fort Worth | Texas | United States | 76104 |
| 30 | Aptinyx Clinical Site | Plano | Texas | United States | 75093 |
Sponsors and Collaborators
- Aptinyx
- Worldwide Clinical Trials
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Aptinyx
ClinicalTrials.gov Identifier:
NCT05181995
Other Study ID Numbers:
- NYX-783-2009
First Posted:
Jan 10, 2022
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No