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

A Phase 2, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of PRAX-114 in Participants With Post-Traumatic Stress Disorder

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Praxis Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Praxis Research Site
    • Rogers, Arkansas, United States, 72758
      • Praxis Research Site
  • California
    • Lemon Grove, California, United States, 91945
      • Praxis Research Site
    • Westlake Village, California, United States, 91362
      • Praxis Research Site
  • Florida
    • Fort Myers, Florida, United States, 33908
      • Praxis Research Site
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Praxis Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Praxis Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Praxis Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Praxis Research Site
    • Dayton, Ohio, United States, 45417
      • Praxis Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Praxis Research Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Praxis Research Site
    • Media, Pennsylvania, United States, 19063
      • Praxis Research Site
  • Texas
    • Austin, Texas, United States, 78737
      • Praxis Research Site
    • Dallas, Texas, United States, 75231
      • Praxis Research Site
  • Washington
    • Everett, Washington, United States, 98201
      • Praxis Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Double-blind PRAX-114; Double-blind period - 40 or 60 mg PRAX-114 once daily in the evening	Drug: 60 mg PRAX-114 or 40 mg PRAX-114; Once daily oral treatment for 4 weeks
PLACEBO_COMPARATOR: Double-blind Placebo; Double-blind period - placebo once daily in the evening	Drug: Placebo; Once daily oral treatment for 4 weeks
EXPERIMENTAL: Open-label Extension PRAX-114; Open-label extension period - 40 mg PRAX-114 once daily in the evening	Drug: 40 mg PRAX-114; Once daily oral treatment for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score at Day 29	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.	29 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the CAPS-5 total score at Day 15 and 43	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.	15 days and 43 days
Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 29, Day 15, and Day 43	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).	15 days, 29 days, and 43 days
Change from baseline in Clinical Global Impression-Improvement (CGI-I) score at Day 29, Day 15, and Day 43	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).	15 days, 29 days, and 43 days
Change from baseline in the CAPS-5 symptom cluster scores at Day 29, Day 15, and Day 43	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.	15 days, 29 days, and 43 days
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) at Day 29, Day 15, and all other timepoints	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.	8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
Change from baseline in the Sheehan Disability Scale (SDS) at Day 29, Day 15, and Day 43	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.	15 days, 29 days, 43 days
Patient Global Impression-Improvement (PGI-I) score at Day 29, Day 15 and all other time points	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).	8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
Change from baseline in the Insomnia Severity Index (ISI) at Day 29, Day 15, and all other timepoints	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.	8 days, 15 days, 22 days, 29 days, 35 days, and 43 days

Collaborators and Investigators

• Sponsor: Praxis Precision Medicines

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2022
• Primary Completion (ACTUAL): August 1, 2022
• Study Completion (ACTUAL): September 23, 2022

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (ACTUAL): March 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Agents, GABA; Receptors, GABA-A; Allosteric Regulation; PRAX-114
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Mental Disorders; Trauma and Stressor Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pramoxine
• Other Study ID Numbers: PRAX-114-221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No