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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Post-traumatic Stress Disorder, Post Traumatic Stress Disorder, Stress Disorder, Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Mental Disorder

In brief

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.

Key facts

Study ID

NCT05260541

Run by

Praxis Precision Medicines

People needed

11

Starts

2022-01-25

Expected to finish

2022-09-23

Last updated by the study team

2022-12-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Praxis Research Site — Phoenix, Arizona, United States
• Praxis Research Site — Little Rock, Arkansas, United States
• Praxis Research Site — Rogers, Arkansas, United States
• Praxis Research Site — Lemon Grove, California, United States
• Praxis Research Site — Westlake Village, California, United States
• Praxis Research Site — Fort Myers, Florida, United States
• Praxis Research Site — Decatur, Georgia, United States
• Praxis Research Site — Boston, Massachusetts, United States
• Praxis Research Site — Las Vegas, Nevada, United States
• Praxis Research Site — Cincinnati, Ohio, United States
• Praxis Research Site — Dayton, Ohio, United States
• Praxis Research Site — Oklahoma City, Oklahoma, United States
• Praxis Research Site — Allentown, Pennsylvania, United States
• Praxis Research Site — Media, Pennsylvania, United States
• Praxis Research Site — Austin, Texas, United States
• Praxis Research Site — Dallas, Texas, United States
• Praxis Research Site — Everett, Washington, United States

Full record on ClinicalTrials.gov

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