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

Praxis Precision Medicines

Status and phase: Terminated; Phase 2

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

Treatments: Drug: 40 mg PRAX-114; Drug: 60 mg PRAX-114 or 40 mg PRAX-114; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05260541

PRAX-114-221

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. DSM-5 diagnosis of PTSD with duration >6 months, as confirmed by psychiatric evaluation.
2. CAPS-5 total score ≥30 at Screening and Baseline.
3. Body mass index (BMI) of 18 to 38 kg/m2.

Exclusion criteria

1. Experienced the index traumatic event before age 16.
2. Has an active legal, worker's compensation, or disability claim for PTSD.
3. 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.
4. HAM-D17 score of >18 at Screening or Baseline.
5. Any current psychiatric disorder (other than PTSD).
6. Lifetime history of seizures, including febrile seizures.
7. Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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11 participants in 3 patient groups, including a placebo group

Double-blind PRAX-114

Experimental group

Description:

Double-blind period - 40 or 60 mg PRAX-114 once daily in the evening

Treatment:

Drug: 60 mg PRAX-114 or 40 mg PRAX-114

Double-blind Placebo

Placebo Comparator group

Description:

Double-blind period - placebo once daily in the evening

Treatment:

Drug: Placebo

Open-label Extension PRAX-114

Experimental group

Description:

Open-label extension period - 40 mg PRAX-114 once daily in the evening

Treatment:

Drug: 40 mg PRAX-114