NCT04044664

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

A Study to Evaluate the Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Aptinyx · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Placebo oral capsule	Matching placebo capsules.
DRUG	NYX-783	NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

Timeline

• Start date: 2019-01-25
• Primary completion: 2020-08-05
• Completion: 2020-08-05
• First posted: 2019-08-05
• Last updated: 2022-05-17
• Results posted: 2022-05-13

Locations

37 sites across 1 country: United States

Regulatory

• FDA-regulated drug study