Clinical trial NCT05181995: Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: PTSD
Lead sponsor: Aptinyx
Sponsor class: INDUSTRY
Collaborators: name: Worldwide Clinical Trials
First posted: 2022-01-10
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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.

Primary outcomes:
measure: CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition)
timeFrame: study endpoint, up to 10 weeks
Secondary outcomes:
measure: CGI-S (Clinician Global Impression - Severity)
timeFrame: study endpoint, up to 10 weeks
measure: PGI-S (Patient Global Impression - Severity)
timeFrame: study endpoint, up to 10 weeks
measure: SDS (Sheehan Disability Scale)
timeFrame: study endpoint, up to 10 weeks
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Aptinyx Clinical Site
state: Alabama
city: Phoenix
country: United States
facility: Aptinyx Clinical Site
state: Arizona
city: Bentonville
country: United States
facility: Aptinyx Clinical Site
state: Arkansas
city: Bellflower
country: United States
facility: Aptinyx Clinical Site
state: California
city: Glendale
country: United States
facility: Aptinyx Clinical Site
state: California
city: La Jolla
country: United States
facility: Aptinyx Clinical Site
state: California
city: Oceanside
country: United States
facility: Aptinyx Clinical Site
state: California
city: Riverside
country: United States
facility: Aptinyx Clinical Site
state: California
city: Santa Ana
country: United States
facility: Aptinyx Clinical Site
state: California
city: Temecula
country: United States
facility: Aptinyx Clinical Site
state: California
city: Torrance
country: United States
facility: Aptinyx Clinical Site
state: California
city: Colorado Springs
country: United States
facility: Aptinyx Clinical Site
state: Colorado
city: Denver
country: United States
facility: Aptinyx Clinical Site
state: Colorado
city: Hialeah
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Hollywood
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Jacksonville
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Jupiter
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Miami Lakes
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Miami
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Miami
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Okeechobee
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Orlando
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Aptinyx Clinical Site
state: Georgia
city: Boston
country: United States
facility: Aptinyx Clinical Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Aptinyx Clinical Site
state: Nevada
city: Albuquerque
country: United States
facility: Aptinyx Clinical Site
state: New Mexico
city: New York
country: United States
facility: Aptinyx Clinical Site
state: New York
city: Cincinnati
country: United States
facility: Aptinyx Clinical Site
state: Ohio
city: Dayton
country: United States
facility: Aptinyx Clinical Site
state: Ohio
city: Kettering
country: United States
facility: Aptinyx Clinical Site
state: Ohio
city: North Canton
country: United States
facility: Aptinyx Clinical Site
state: Ohio
city: Media
country: United States
facility: Aptinyx Clinical Site
state: Pennsylvania
city: Memphis
country: United States
facility: Aptinyx Clinical Site
state: Tennessee
city: Austin
country: United States
facility: Aptinyx Clinical Site
state: Texas
city: Fort Worth
country: United States
facility: Aptinyx Clinical Site
state: Texas
city: Houston
country: United States
facility: Aptinyx Clinical Site
state: Texas
city: Plano
country: United States
facility: Aptinyx Clinical Site
state: Texas
Study officials:
References: