Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
NCT ID: NCT04044664
Last Updated: 2022-05-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2019-01-25
2020-08-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo oral capsule
Matching placebo capsules.
NYX-783 Low Dose (10 mg QD)
NYX-783
NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
NYX-783 High Dose (50 mg QD)
NYX-783
NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Interventions
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Placebo oral capsule
Matching placebo capsules.
NYX-783
NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Eligibility Criteria
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Inclusion Criteria
* PCL-5 (PTSD Checklist for DSM-5) ≥38 at screening.
* CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total score ≥30 at screening.
Exclusion Criteria
* Trauma focused psychotherapies.
* Primary traumatic event occurred prior to 2001.
* Primary traumatic event was followed by further major traumatic life episodes.
* Other psychiatric disorders that is the primary focus of treatment or followed/worsened since exposure to the trauma (except for major depressive disorder or anxiety disorders that followed exposure to the trauma or an anxiety disorder that showed a worsening after trauma)
* Current use of medications with primarily central nervous system activities
* Other clinically significant medical histories that may interfere with completing the study.
18 Years
65 Years
ALL
No
Sponsors
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Premier Research Group plc
UNKNOWN
Massachusetts General Hospital
OTHER
Aptinyx
INDUSTRY
Responsible Party
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Locations
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Aptinyx Clinical Site
Tuscaloosa, Alabama, United States
Aptinyx Clinical Site
Phoenix, Arizona, United States
Aptinyx Clinical Site
Little Rock, Arkansas, United States
Aptinyx Clinical Site
Bellflower, California, United States
Aptinyx Clinical Site
Glendale, California, United States
Aptinyx Clinical Site
Imperial, California, United States
Aptinyx Clinical Site
Oakland, California, United States
Aptinyx Clinical Site
Oceanside, California, United States
Aptinyx Clinical Site
Orange, California, United States
Aptinyx Clinical Site
Riverside, California, United States
Aptinyx Clinical Site
San Diego, California, United States
Aptinyx Clinical Site
San Marcos, 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
Colorado Springs, Colorado, United States
Aptinyx Clinical Site
Norwich, Connecticut, United States
Aptinyx Clinical Site
Jacksonville, Florida, United States
Aptinyx Clinical Site
Lauderhill, Florida, United States
Aptinyx Clinical Site
Orlando, Florida, United States
Aptinyx
Atlanta, Georgia, United States
Aptinyx Clinical Site
Atlanta, Georgia, United States
Aptinyx Clinical Site
Hoffman Estates, Illinois, United States
Aptinyx Clinical Site
Boston, Massachusetts, United States
Aptinyx Clinical Site
Las Vegas, Nevada, United States
Aptinyx Clinical Site
Berlin, New Jersey, United States
Aptinyx Clinical Site
Cedarhurst, New York, United States
Aptinyx Clinical Site
New York, New York, United States
Aptinyx Clinical Site
Staten Island, New York, United States
Aptinyx Clinical Site
Salisbury, North Carolina, United States
Aptinyx Clinical Site
Canton, Ohio, United States
Aptinyx Clinical Site
Cincinnati, Ohio, United States
Aptinyx Clinical Site
Oklahoma City, Oklahoma, United States
Aptinyx Clinical Site
Memphis, Tennessee, United States
Aptinyx Clinical Site
Austin, Texas, United States
Aptinyx Clinical Site
San Antonio, Texas, United States
Aptinyx Clinical Site
Bellevue, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NYX-783-2004
Identifier Type: -
Identifier Source: org_study_id
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