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

Sponsor

Praxis Precision Medicines (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05260541

Collaborator

(none)

Enrollment

Locations

Arms

12.2

Anticipated Duration (Months)

0.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-traumatic Stress Disorder Post Traumatic Stress Disorder Stress Disorder Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorder	Drug: 60 mg PRAX-114 or 40 mg PRAX-114 Drug: Placebo Drug: 40 mg PRAX-114	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 25, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Praxis Research Site	Phoenix	Arizona	United States	85012
2	Praxis Research Site	Little Rock	Arkansas	United States	72211
3	Praxis Research Site	Rogers	Arkansas	United States	72758
4	Praxis Research Site	Lemon Grove	California	United States	91945
5	Praxis Research Site	Westlake Village	California	United States	91362
6	Praxis Research Site	Fort Myers	Florida	United States	33908
7	Praxis Research Site	Decatur	Georgia	United States	30030
8	Praxis Research Site	Boston	Massachusetts	United States	02131
9	Praxis Research Site	Las Vegas	Nevada	United States	89102
10	Praxis Research Site	Cincinnati	Ohio	United States	45219
11	Praxis Research Site	Dayton	Ohio	United States	45417
12	Praxis Research Site	Oklahoma City	Oklahoma	United States	73118
13	Praxis Research Site	Allentown	Pennsylvania	United States	18104
14	Praxis Research Site	Media	Pennsylvania	United States	19063
15	Praxis Research Site	Austin	Texas	United States	78737
16	Praxis Research Site	Dallas	Texas	United States	75231
17	Praxis Research Site	Everett	Washington	United States	98201