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

Phase 2
Waitlist Available
Research Sponsored by Praxis Precision Medicines
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days

Summary

This trial tests a pill called PRAX-114 on adults with post-traumatic stress disorder to see if it can help improve mood and reduce anxiety.

Eligible Conditions
  • Trauma and Stressor Related Disorders
  • PTSD
  • Post-Traumatic Stress Disorder
  • Psychiatric Disorder
  • Stress Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score at Day 29
Secondary study objectives
Change from baseline in Clinical Global Impression-Improvement (CGI-I) score at Day 29, Day 15, and Day 43
Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 29, Day 15, and Day 43
Change from baseline in the CAPS-5 symptom cluster scores at Day 29, Day 15, and Day 43
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-label Extension PRAX-114Experimental Treatment1 Intervention
Open-label extension period - 40 mg PRAX-114 once daily in the evening
Group II: Double-blind PRAX-114Experimental Treatment1 Intervention
Double-blind period - 40 or 60 mg PRAX-114 once daily in the evening
Group III: Double-blind PlaceboPlacebo Group1 Intervention
Double-blind period - placebo once daily in the evening
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
40 mg PRAX-114
2021
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Praxis Precision MedicinesLead Sponsor
9 Previous Clinical Trials
1,168 Total Patients Enrolled
~3 spots leftby Dec 2025
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