Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder

NCT04044664 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: NYX-783-2004
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 37

Brief Summary

To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic Stress Disorder population.

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores

  CAPS-5 \[Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)\] is a structured interview for diagnosis and assessment of PTSD. The assessor combines information about frequency and intensity of an item into a severity rating (0-4). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: intrusions (items 1-5, minimum score 0, maximum score 20), avoidance (items 6-7, minimum score 0, maximum score 8), negative alterations in cognitions and mood (items 8-14, minimum score 0, maximum score 28), and alterations in arousal and reactivity (items 15-20, minimum score 0, maximum score 24). CAPS-5 Total Scores range from 0 to 80. A higher score corresponds to more severe PTSD.

  Change from baseline to week 4 (Stage 1)

Secondary Outcomes (6)

• PCL-5 (PTSD-Checklist for DSM-5)

  Change from baseline to week 4 (Stage 1)

• PSQI (Pittsburgh Sleep Quality Index) Global Score

  Change from baseline to week 4 (Stage 1)

• PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score

  Change from baseline to week 4 (Stage 1)

• BAC (Brief Assessment of Cognition) Symbol Coding

  Change from baseline to week 4 (Stage 1)

• CGI-S (Clinical Global Impression - Severity)

  Change from baseline to week 4 (Stage 1)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo oral capsule

NYX-783 Low Dose (10 mg QD)

EXPERIMENTAL

Drug: NYX-783

NYX-783 High Dose (50 mg QD)

EXPERIMENTAL

Drug: NYX-783

Interventions

Placebo oral capsule DRUG

Matching placebo capsules.

Placebo

NYX-783 DRUG

NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

NYX-783 High Dose (50 mg QD); NYX-783 Low Dose (10 mg QD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A primary diagnosis of PTSD \[Post Traumatic Stress Disorder, according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders)\] with the primary traumatic event occurring ≥12 months prior to screening.
• PCL-5 (PTSD Checklist for DSM-5) ≥38 at screening.
• CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total score ≥30 at screening.

You may not qualify if:

• Complex PTSD.
• 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.

Sponsors & Collaborators

• Aptinyx: lead
• Premier Research: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (37)

Aptinyx Clinical Site

Tuscaloosa, Alabama, 35404, United States

Location

Aptinyx Clinical Site

Phoenix, Arizona, 85012, United States

Location

Aptinyx Clinical Site

Little Rock, Arkansas, 30322, United States

Location

Aptinyx Clinical Site

Bellflower, California, 90706, United States

Location

Aptinyx Clinical Site

Glendale, California, 91206, United States

Location

Aptinyx Clinical Site

Imperial, California, 92251, United States

Location

Aptinyx Clinical Site

Oakland, California, 94607, United States

Location

Aptinyx Clinical Site

Oceanside, California, 92056, United States

Location

Aptinyx Clinical Site

Orange, California, 92868, United States

Location

Aptinyx Clinical Site

Riverside, California, 92503, United States

Location

Aptinyx Clinical Site

San Diego, California, 92103, United States

Location

Aptinyx Clinical Site

San Marcos, California, 92078, United States

Location

Aptinyx Clinical Site

Santa Ana, California, 92705, United States

Location

Aptinyx Clinical Site

Temecula, California, 32591, United States

Location

Aptinyx Clinical Site

Torrance, California, 90502, United States

Location

Aptinyx Clinical Site

Colorado Springs, Colorado, 80910, United States

Location

Aptinyx Clinical Site

Norwich, Connecticut, 06360, United States

Location

Aptinyx Clinical Site

Jacksonville, Florida, 32256, United States

Location

Aptinyx Clinical Site

Lauderhill, Florida, 33319, United States

Location

Aptinyx Clinical Site

Orlando, Florida, 32801, United States

Location

Aptinyx

Atlanta, Georgia, 30329, United States

Location

Aptinyx Clinical Site

Atlanta, Georgia, 30331, United States

Location

Aptinyx Clinical Site

Hoffman Estates, Illinois, 60619, United States

Location

Aptinyx Clinical Site

Boston, Massachusetts, 02131, United States

Location

Aptinyx Clinical Site

Las Vegas, Nevada, 89102, United States

Location

Aptinyx Clinical Site

Berlin, New Jersey, 08009, United States

Location

Aptinyx Clinical Site

Cedarhurst, New York, 11516, United States

Location

Aptinyx Clinical Site

New York, New York, 10036, United States

Location

Aptinyx Clinical Site

Staten Island, New York, 10312, United States

Location

Aptinyx Clinical Site

Salisbury, North Carolina, 28144, United States

Location

Aptinyx Clinical Site

Canton, Ohio, 44720, United States

Location

Aptinyx Clinical Site

Cincinnati, Ohio, 45219, United States

Location

Aptinyx Clinical Site

Oklahoma City, Oklahoma, 73107, United States

Location

Aptinyx Clinical Site

Memphis, Tennessee, 38119, United States

Location

Aptinyx Clinical Site

Austin, Texas, 78737, United States

Location

Aptinyx Clinical Site

San Antonio, Texas, 78229, United States

Location

Aptinyx Clinical Site

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Aptinyx Clinical Development
• Organization: Aptinyx

clinicalstudies@aptinyx.com

847-871-0377

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to receive placebo or NYX-783.

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: August 5, 2019
• Study Start: January 25, 2019
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: May 17, 2022
• Results First Posted: May 13, 2022

Record last verified: 2022-05

Locations

US (37)