We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    nyx-783
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05181995
Recruitment Status : Recruiting
First Posted : January 10, 2022
Last Update Posted : December 1, 2022
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Aptinyx

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
PTSD Drug: NYX-783 Drug: Placebo Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 13, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. CGI-S (Clinician Global Impression - Severity) [ Time Frame: study endpoint, up to 10 weeks ]
    Change from Baseline in CGI-S

  2. PGI-S (Patient Global Impression - Severity) [ Time Frame: study endpoint, up to 10 weeks ]
    Change from Baseline in PGI-S

  3. SDS (Sheehan Disability Scale) [ Time Frame: study endpoint, up to 10 weeks ]
    Change from Baseline in SDS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05181995


Contacts
Layout table for location contacts
Contact: Aptinyx Clinical Development 847-871-0377 ext 1 clinicalstudies@aptinyx.com

Locations
Layout table for location information
United States, Alabama
Aptinyx Clinical Site Recruiting
Tuscaloosa, Alabama, United States, 35404
United States, Arizona
Aptinyx Clinical Site Recruiting
Phoenix, Arizona, United States, 85012
United States, Arkansas
Aptinyx Clinical Site Recruiting
Bentonville, Arkansas, United States, 72712
United States, California
Aptinyx Clinical Site Recruiting
Bellflower, California, United States, 90706
Aptinyx Clinical Site Recruiting
Glendale, California, United States, 91206
Aptinyx Clinical Site Recruiting
La Jolla, California, United States, 92037
Aptinyx Clinical Site Recruiting
Oceanside, California, United States, 92056
Aptinyx Clinical Site Recruiting
Riverside, California, United States, 92506
Aptinyx Clinical Site Recruiting
Santa Ana, California, United States, 92705
Aptinyx Clinical Site Recruiting
Temecula, California, United States, 92591
Aptinyx Clinical Site Recruiting
Torrance, California, United States, 90502
United States, Colorado
Aptinyx Clinical Site Recruiting
Colorado Springs, Colorado, United States, 80910
Aptinyx Clinical Site Recruiting
Denver, Colorado, United States, 80209
United States, Florida
Aptinyx Clinical Site Recruiting
Hialeah, Florida, United States, 33012
Aptinyx Clinical Site Recruiting
Hollywood, Florida, United States, 33020
Aptinyx Clinical Site Recruiting
Jacksonville, Florida, United States, 32256
Aptinyx Clinical Site Recruiting
Jupiter, Florida, United States, 33458
Aptinyx Clinical Site Recruiting
Miami Lakes, Florida, United States, 33014
Aptinyx Clinical Site Recruiting
Miami, Florida, United States, 33125
Aptinyx Clinical Site Recruiting
Miami, Florida, United States, 33186
Aptinyx Clinical Site Recruiting
Okeechobee, Florida, United States, 34972
Aptinyx Clinical Site Recruiting
Orlando, Florida, United States, 32801
United States, Georgia
Aptinyx Clinical Site Recruiting
Atlanta, Georgia, United States, 30331
United States, Massachusetts
Aptinyx Clinical Site Recruiting
Boston, Massachusetts, United States, 02131
United States, Nevada
Aptinyx Clinical Site Recruiting
Las Vegas, Nevada, United States, 89102
United States, New York
Aptinyx Clinical Site Recruiting
New York, New York, United States, 10036
United States, Ohio
Aptinyx Clinical Site Recruiting
Cincinnati, Ohio, United States, 45219
Aptinyx Clinical Site Recruiting
Dayton, Ohio, United States, 45432
Aptinyx Clinical Site Recruiting
Kettering, Ohio, United States, 45439
Aptinyx Clinical Site Recruiting
North Canton, Ohio, United States, 44720
United States, Pennsylvania
Aptinyx Clinical Site Recruiting
Media, Pennsylvania, United States, 19063
United States, Tennessee
Aptinyx Clinical Site Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Aptinyx Clinical Site Recruiting
Austin, Texas, United States, 78737
Aptinyx Clinical Site Recruiting
Fort Worth, Texas, United States, 76104
Aptinyx Clinical Site Recruiting
Plano, Texas, United States, 75093
Sponsors and Collaborators
Aptinyx
Worldwide Clinical Trials
Layout table for additonal information
Responsible Party: Aptinyx
ClinicalTrials.gov Identifier: NCT05181995    
Other Study ID Numbers: NYX-783-2009
First Posted: January 10, 2022    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No