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40 mg PRAX-114 for 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
CAPS-5 total score ≥30 at Screening and Baseline.
Body mass index (BMI) of 18 to 38 kg/m2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
Awards & highlights

Study Summary

This trial is a 4-week study of a new drug for PTSD, with an 8-week extension for those who want to continue.

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a DSM-5 diagnosis of PTSD with duration >6 months, as confirmed by psychiatric evaluation.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score at Day 29
Secondary outcome measures
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

Side effects data

From 2022 Phase 2 trial • 24 Patients • NCT05021978
57%
Dizziness
43%
Headache
14%
Asthenopia
14%
Thirst
14%
Psychomotor hyperactivity
14%
Faeces hard
14%
Nausea
14%
Anxiety
14%
Essential tremor
14%
Initial Insomnia
14%
Dyspnoea
14%
Throat irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT)
Part B: PRAX-944 20mg to 120mg OLT
Part B: Placebo RWD
Part B: PRAX-944 120mg Randomized Withdrawal Phase (RWD)

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the requirements to be a participant in this research?

"Eligible patients for this clinical trial should present with moral injury and be between 18-65 years old. There are only 11 spots available."

Answered by AI

Can patients who are over the age of 50 participate in this trial?

"This particular study is only open to people who are 18-65. Out of the 1323 clinical trials, 371 are for people under 18 and 1052 are for people over 65."

Answered by AI

Are there numerous test facilities in Canada for this research project?

"17 clinical trial sites are presently running this study. They are located in cities such as Little Rock, Allentown, and Phoenix. If you are interested in participating, it would be best to select the trial site nearest you to avoid excessive travel."

Answered by AI

40 mg PRAX-114 is an FDA-approved medication, correct?

"PRAX-114's safety was given a score of 2. This is due to it being a Phase 2 medication, so while there is data suggesting it is safe, there is none yet affirming that it is an effective treatment."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Arkansas
West Virginia
How old are they?
65+
18 - 65
What site did they apply to?
Praxis Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder
2022. "A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05260541.
~3 spots leftby Apr 2025
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