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

Aptinyx

Status and phase: Completed; Phase 2

Conditions: Post-Traumatic Stress Disorder

Treatments: Drug: Placebo oral capsule; Drug: NYX-783

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04044664

NYX-783-2004

Details and patient eligibility

About

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

Full description

The study will be a 10 to 12-week study, including a 1 to 3-week screening Period, followed by a double-blind, randomized, placebo-controlled, parallel-group Treatment Period, and a 1-week follow-up Period. Subjects eligible for the study will be randomized to receive either NYX-783 (4-weeks) or placebo (4 or 8-weeks).

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo oral capsule

NYX-783 Low Dose (10 mg QD)

Experimental group

Treatment:

Drug: NYX-783

NYX-783 High Dose (50 mg QD)

Experimental group

Treatment:

Drug: NYX-783