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

PTSD Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05181995
• Other study ID #: NYX-783-2009
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: December 13, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: April 2023
• Source: Aptinyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 121
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• PTSD

Intervention

Drug:
• NYX-783
NYX-783
• Placebo
Placebo for 50 mg NYX-783

Locations

Country	Name	City	State
United States	Aptinyx Clinical Site	Albuquerque	New Mexico
United States	Aptinyx Clinical Site	Atlanta	Georgia
United States	Aptinyx Clinical Site	Austin	Texas
United States	Aptinyx Clinical Site	Bellflower	California
United States	Aptinyx Clinical Site	Bentonville	Arkansas
United States	Aptinyx Clinical Site	Boston	Massachusetts
United States	Aptinyx Clinical Site	Cincinnati	Ohio
United States	Aptinyx Clinical Site	Colorado Springs	Colorado
United States	Aptinyx Clinical Site	Dayton	Ohio
United States	Aptinyx Clinical Site	Denver	Colorado
United States	Aptinyx Clinical Site	Fort Worth	Texas
United States	Aptinyx Clinical Site	Glendale	California
United States	Aptinyx Clinical Site	Hialeah	Florida
United States	Aptinyx Clinical Site	Hollywood	Florida
United States	Aptinyx Clinical Site	Houston	Texas
United States	Aptinyx Clinical Site	Jacksonville	Florida
United States	Aptinyx Clinical Site	Jupiter	Florida
United States	Aptinyx Clinical Site	Kettering	Ohio
United States	Aptinyx Clinical Site	La Jolla	California
United States	Aptinyx Clinical Site	Las Vegas	Nevada
United States	Aptinyx Clinical Site	Media	Pennsylvania
United States	Aptinyx Clinical Site	Memphis	Tennessee
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	New York	New York
United States	Aptinyx Clinical Site	North Canton	Ohio
United States	Aptinyx Clinical Site	Oceanside	California
United States	Aptinyx Clinical Site	Okeechobee	Florida
United States	Aptinyx Clinical Site	Orlando	Florida
United States	Aptinyx Clinical Site	Phoenix	Arizona
United States	Aptinyx Clinical Site	Plano	Texas
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	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Aptinyx	Worldwide Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CGI-S (Clinician Global Impression - Severity)	Change from Baseline in CGI-S	study endpoint, up to 10 weeks
Secondary	PGI-S (Patient Global Impression - Severity)	Change from Baseline in PGI-S	study endpoint, up to 10 weeks
Secondary	SDS (Sheehan Disability Scale)	Change from Baseline in SDS	study endpoint, up to 10 weeks