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

Phase 2

Terminated

• Conditions: Post-traumatic Stress Disorder; Stress Disorder; Mental Disorder; Post Traumatic Stress Disorder; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders
• Interventions: Drug: 60 mg PRAX-114 or 40 mg PRAX-114; Drug: Placebo; Drug: 40 mg PRAX-114

• Registration Number: NCT05260541
• Lead Sponsor: Praxis Precision Medicines

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-25
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-03-02
• Primary Completion: 2022-08-01
• Study Completion: 2022-09-23
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double-blind PRAX-114	60 mg PRAX-114 or 40 mg PRAX-114	Double-blind period - 40 or 60 mg PRAX-114 once daily in the evening
Double-blind Placebo	Placebo	Double-blind period - placebo once daily in the evening
Open-label Extension PRAX-114	40 mg PRAX-114	Open-label extension period - 40 mg PRAX-114 once daily in the evening

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score at Day 29	29 days	The CAPS-5 is a clinician-rated PTSD rating scale consisting of 30 items; the total score is calculated as the sum of 20 items assessing the 20 DSM-5 PTSD symptoms. These symptom items are scored on a 5-point scale from 0 (absent) to 4 (extreme/incapacitating). The total score of the 20 items ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. Therefore, a decrease in the total score indicates symptom improvement.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression-Improvement (PGI-I) score at Day 29, Day 15 and all other time points	8 days, 15 days, 22 days, 29 days, 35 days, and 43 days	The PGI-I scale is a global self-assessment used to rate the response of a participant's condition to therapy or intervention. It consists of 1 question that asks the participant to rate their current condition compared to how it was prior to beginning treatment on a scale of 1 (very much better) to 7 (very much worse).
Change from baseline in the Insomnia Severity Index (ISI) at Day 29, Day 15, and all other timepoints	8 days, 15 days, 22 days, 29 days, 35 days, and 43 days	The ISI is a patient-reported measure of insomnia consisting of 7 items assessing the nature, severity, and impact of insomnia. These items are scored on a 5-point scale from 0 (no problem) to 4 (very severe problem). The total score ranges from 0 to 28 with higher scores indicating more severe insomnia. Therefore, a decrease in the total score indicates symptom improvement.
Change from baseline in the CAPS-5 total score at Day 15 and 43	15 days and 43 days	The CAPS-5 is a clinician-rated PTSD rating scale consisting of 30 items; the total score is calculated as the sum of 20 items assessing the 20 DSM-5 PTSD symptoms. These symptom items are scored on a 5-point scale from 0 (absent) to 4 (extreme/incapacitating). The total score of the 20 items ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. Therefore, a decrease in the total score indicates symptom improvement.
Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 29, Day 15, and Day 43	15 days, 29 days, and 43 days	The CGI-S assesses the clinician's impression of the participant's current depression symptoms. The clinician should use his/her total clinical experience with this patient population and rate the current severity of the participant's mental illness on a 7-point scale from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients).
Change from baseline in Clinical Global Impression-Improvement (CGI-I) score at Day 29, Day 15, and Day 43	15 days, 29 days, and 43 days	The CGI-I assesses the participant's improvement (or worsening). The clinician is required to assess the participant's condition relative to Baseline (Day 1) on a 7-point scale from 1 (Very much improved) to 7 (Very much worse).
Change from baseline in the CAPS-5 symptom cluster scores at Day 29, Day 15, and Day 43	15 days, 29 days, and 43 days	The CAPS-5 is a clinician-rated PTSD rating scale consisting of 30 items; 20 of these items assess the 20 DSM-5 PTSD symptoms. Symptom cluster scores are calculated as the sum of the individual item severity scores for symptoms contained in a given DSM-5 cluster. These symptom items are scored on a 5-point scale from 0 (absent) to 4 (extreme/incapacitating). Cluster score ranges vary by symptom cluster. Higher scores indicate more severe PTSD symptoms. Therefore, a decrease in the cluster score indicates symptom improvement.
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) at Day 29, Day 15, and all other timepoints	8 days, 15 days, 22 days, 29 days, 35 days, and 43 days	The PCL-5 is a patient-reported PTSD rating scale consisting of 20 items; these items assess the 20 DSM-5 PTSD symptoms. These symptom items are scored on a 5-point scale from 0 (not at all) to 4 (extremely). The total score of the 20 items ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. Therefore, a decrease in the total score indicates symptom improvement.
Change from baseline in the Sheehan Disability Scale (SDS) at Day 29, Day 15, and Day 43	15 days, 29 days, 43 days	The SDS is a patient-reported measure of disability. The SDS is a composite of 3 items designed to measure the extent to which 3 major domains in the patient's life are functionally impaired by psychiatric or medical symptoms: work, social life/leisure activities, and family life/home responsibilities. Each domain is rated on an 11-point scale from 0 (not at all) to 10 (extremely). The total score is calculated as the sum of the domain scores and ranges from 0 to 30. Higher scores indicate greater disability. Therefore, a decrease in the total score or on individual domains indicates less disability.

Trial Locations

Locations (1)

Praxis Research Site; 🇺🇸 Everett, Washington, United States