Status:
TERMINATED
A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder
Lead Sponsor:
Praxis Precision Medicines
Conditions:
Post-traumatic Stress Disorder
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 effica...
Eligibility Criteria
Inclusion
- DSM-5 diagnosis of PTSD with duration \>6 months, as confirmed by psychiatric evaluation.
- CAPS-5 total score ≥30 at Screening and Baseline.
- Body mass index (BMI) of 18 to 38 kg/m2.
Exclusion
- Experienced the index traumatic event before age 16.
- Has an active legal, worker's compensation, or disability claim for PTSD.
- Lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive-compulsive disorder or a history of a psychotic mood episode in last 2 years.
- HAM-D17 score of \>18 at Screening or Baseline.
- Any current psychiatric disorder (other than PTSD).
- Lifetime history of seizures, including febrile seizures.
- Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05260541
Start Date
January 25 2022
End Date
September 23 2022
Last Update
December 1 2022
Active Locations (17)
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1
Praxis Research Site
Phoenix, Arizona, United States, 85012
2
Praxis Research Site
Little Rock, Arkansas, United States, 72211
3
Praxis Research Site
Rogers, Arkansas, United States, 72758
4
Praxis Research Site
Lemon Grove, California, United States, 91945