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

NCT05260541 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-12-01

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2022-08-01
Completion
2022-09-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05260541 on ClinicalTrials.gov