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

April 6, 2023 updated by: Aptinyx

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)

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35404
        • Aptinyx Clinical Site
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Aptinyx Clinical Site
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Aptinyx Clinical Site
    • California
      • Bellflower, California, United States, 90706
        • Aptinyx Clinical Site
      • Glendale, California, United States, 91206
        • Aptinyx Clinical Site
      • La Jolla, California, United States, 92037
        • Aptinyx Clinical Site
      • Oceanside, California, United States, 92056
        • Aptinyx Clinical Site
      • Riverside, California, United States, 92506
        • Aptinyx Clinical Site
      • Santa Ana, California, United States, 92705
        • Aptinyx Clinical Site
      • Temecula, California, United States, 92591
        • Aptinyx Clinical Site
      • Torrance, California, United States, 90502
        • Aptinyx Clinical Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Aptinyx Clinical Site
      • Denver, Colorado, United States, 80209
        • Aptinyx Clinical Site
    • Florida
      • Hialeah, Florida, United States, 33012
        • Aptinyx Clinical Site
      • Hollywood, Florida, United States, 33020
        • Aptinyx Clinical Site
      • Jacksonville, Florida, United States, 32256
        • Aptinyx Clinical Site
      • Jupiter, Florida, United States, 33458
        • Aptinyx Clinical Site
      • Miami, Florida, United States, 33125
        • Aptinyx Clinical Site
      • Miami, Florida, United States, 33174
        • Aptinyx Clinical Site
      • Miami Lakes, Florida, United States, 33014
        • Aptinyx Clinical Site
      • Okeechobee, Florida, United States, 34972
        • Aptinyx Clinical Site
      • Orlando, Florida, United States, 32801
        • Aptinyx Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Aptinyx Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Aptinyx Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Aptinyx Clinical Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Aptinyx Clinical Site
    • New York
      • New York, New York, United States, 10036
        • Aptinyx Clinical Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Aptinyx Clinical Site
      • Dayton, Ohio, United States, 45432
        • Aptinyx Clinical Site
      • Kettering, Ohio, United States, 45439
        • Aptinyx Clinical Site
      • North Canton, Ohio, United States, 44720
        • Aptinyx Clinical Site
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Aptinyx Clinical Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Aptinyx Clinical Site
    • Texas
      • Austin, Texas, United States, 78737
        • Aptinyx Clinical Site
      • Fort Worth, Texas, United States, 76104
        • Aptinyx Clinical Site
      • Houston, Texas, United States, 77090
        • Aptinyx Clinical Site
      • Plano, Texas, United States, 75093
        • Aptinyx Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo QD
Drug: Placebo
Placebo for 50 mg NYX-783
Experimental: 50 mg NYX-783 QD
Drug: NYX-783
NYX-783

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition)
Time Frame: study endpoint, up to 10 weeks
Change from Baseline in CAPS-5
study endpoint, up to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGI-S (Clinician Global Impression - Severity)
Time Frame: study endpoint, up to 10 weeks
Change from Baseline in CGI-S
study endpoint, up to 10 weeks
PGI-S (Patient Global Impression - Severity)
Time Frame: study endpoint, up to 10 weeks
Change from Baseline in PGI-S
study endpoint, up to 10 weeks
SDS (Sheehan Disability Scale)
Time Frame: study endpoint, up to 10 weeks
Change from Baseline in SDS
study endpoint, up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aptinyx

Collaborators

Worldwide Clinical Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2021

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NYX-783-2009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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