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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-25

Study Completion Date

2022-09-23

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Double-blind PRAX-114

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

Group Type EXPERIMENTAL

60 mg PRAX-114 or 40 mg PRAX-114

Intervention Type DRUG

Once daily oral treatment for 4 weeks

Double-blind Placebo

Double-blind period - placebo once daily in the evening

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily oral treatment for 4 weeks

Open-label Extension PRAX-114

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

Group Type EXPERIMENTAL

40 mg PRAX-114

Intervention Type DRUG

Once daily oral treatment for 8 weeks

Interventions

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60 mg PRAX-114 or 40 mg PRAX-114

Once daily oral treatment for 4 weeks

Intervention Type DRUG

Placebo

Once daily oral treatment for 4 weeks

Intervention Type DRUG

40 mg PRAX-114

Once daily oral treatment for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No