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40 mg PRAX-114 for Trauma and Stressor Related Disorders

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
  • Post-Traumatic Stress Disorder
  • Stress Disorders
  • Psychiatric Disorder

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

Side effects data

From 2022 Phase 2 trial • 24 Patients • NCT05021978
35%
Constipation
35%
Dizziness
24%
Cognitive disorder
18%
Insomnia
18%
Fatigue
12%
Paraesthesia
6%
Balance disorder
6%
Cyst
6%
Hallucinations, mixed
6%
Anal pruritus
6%
Disturbance in attention
6%
Somnolence
6%
Dizziness postural
6%
Dry mouth
6%
Migraine
6%
Speech disorder
6%
Erythema
6%
Nausea
6%
Confusional state
6%
Headache
6%
Blood creatinine increased
6%
Swelling face
6%
Hot flush
6%
Hypoaesthesia
6%
Nystagmus
6%
Hypotension
6%
Anxiety
6%
Arthralgia
6%
Head discomfort
6%
Photosensitivity reaction
6%
Muscle fatigue
6%
Increased appetite
6%
Photophobia
6%
Gait disturbance
6%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part B: PRAX-944 20mg to 120mg OLT
Part B: Placebo RWD
Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT)
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
~3 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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