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

NCT ID: NCT05181995

Last Updated: 2023-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-13

Study Completion Date

2023-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PTSD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

50 mg NYX-783 QD

50 mg NYX-783 QD

Group Type EXPERIMENTAL

NYX-783

Intervention Type DRUG

NYX-783

Placebo

Placebo QD

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for 50 mg NYX-783

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NYX-783

NYX-783

Intervention Type DRUG

Placebo

Placebo for 50 mg NYX-783

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Worldwide Clinical Trials

OTHER

Sponsor Role collaborator

Aptinyx

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aptinyx Clinical Site

Tuscaloosa, Alabama, United States

Site Status

Aptinyx Clinical Site

Phoenix, Arizona, United States

Site Status

Aptinyx Clinical Site

Bentonville, Arkansas, United States

Site Status

Aptinyx Clinical Site

Bellflower, California, United States

Site Status

Aptinyx Clinical Site

Glendale, California, United States

Site Status

Aptinyx Clinical Site

La Jolla, California, United States

Site Status

Aptinyx Clinical Site

Oceanside, California, United States

Site Status

Aptinyx Clinical Site

Riverside, California, United States

Site Status

Aptinyx Clinical Site

Santa Ana, California, United States

Site Status

Aptinyx Clinical Site

Temecula, California, United States

Site Status

Aptinyx Clinical Site

Torrance, California, United States

Site Status

Aptinyx Clinical Site

Colorado Springs, Colorado, United States

Site Status

Aptinyx Clinical Site

Denver, Colorado, United States

Site Status

Aptinyx Clinical Site

Hialeah, Florida, United States

Site Status

Aptinyx Clinical Site

Hollywood, Florida, United States

Site Status

Aptinyx Clinical Site

Jacksonville, Florida, United States

Site Status

Aptinyx Clinical Site

Jupiter, Florida, United States

Site Status

Aptinyx Clinical Site

Miami, Florida, United States

Site Status

Aptinyx Clinical Site

Miami, Florida, United States

Site Status

Aptinyx Clinical Site

Miami Lakes, Florida, United States

Site Status

Aptinyx Clinical Site

Okeechobee, Florida, United States

Site Status

Aptinyx Clinical Site

Orlando, Florida, United States

Site Status

Aptinyx Clinical Site

Atlanta, Georgia, United States

Site Status

Aptinyx Clinical Site

Boston, Massachusetts, United States

Site Status

Aptinyx Clinical Site

Las Vegas, Nevada, United States

Site Status

Aptinyx Clinical Site

Albuquerque, New Mexico, United States

Site Status

Aptinyx Clinical Site

New York, New York, United States

Site Status

Aptinyx Clinical Site

Cincinnati, Ohio, United States

Site Status

Aptinyx Clinical Site

Dayton, Ohio, United States

Site Status

Aptinyx Clinical Site

Kettering, Ohio, United States

Site Status

Aptinyx Clinical Site

North Canton, Ohio, United States

Site Status

Aptinyx Clinical Site

Media, Pennsylvania, United States

Site Status

Aptinyx Clinical Site

Memphis, Tennessee, United States

Site Status

Aptinyx Clinical Site

Austin, Texas, United States

Site Status

Aptinyx Clinical Site

Fort Worth, Texas, United States

Site Status

Aptinyx Clinical Site

Houston, Texas, United States

Site Status

Aptinyx Clinical Site

Plano, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NYX-783-2009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.