NCT05260541

A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder

A Phase 2, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of PRAX-114 in Participants With Post-Traumatic Stress Disorder

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Praxis Precision Medicines · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial is comprised of a 4-week randomized, double-blind, placebo-controlled treatment period followed by an optional 8-week open-label extension (OLE) period. This trial will evaluate the efficacy and safety of oral PRAX-114 flexibly dosed at 40 to 60 mg for 4 weeks compared to placebo in adults with PTSD. The OLE period consisting of treatment with 40 mg PRAX-114 for 8 weeks will provide additional efficacy and safety data.

Conditions

• Post-traumatic Stress Disorder
• Post Traumatic Stress Disorder
• Stress Disorder
• Stress Disorders, Post-Traumatic
• Trauma and Stressor Related Disorders
• Mental Disorder

Interventions

Type	Name	Description
DRUG	60 mg PRAX-114 or 40 mg PRAX-114	Once daily oral treatment for 4 weeks
DRUG	Placebo	Once daily oral treatment for 4 weeks
DRUG	40 mg PRAX-114	Once daily oral treatment for 8 weeks

Timeline

• Start date: 2022-01-25
• Primary completion: 2022-08-01
• Completion: 2022-09-23
• First posted: 2022-03-02
• Last updated: 2022-12-01

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study