Study Stopped
No longer developing for this indication
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
1 other identifier
interventional
11
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2022
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 25, 2022
CompletedFirst Submitted
Initial submission to the registry
February 18, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2022
CompletedDecember 1, 2022
November 1, 2022
6 months
February 18, 2022
November 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Change from baseline in the CAPS-5 total score at Day 15 and 43
15 days and 43 days
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
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
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
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
- +3 more secondary outcomes
Study Arms (3)
Double-blind PRAX-114
EXPERIMENTALDouble-blind period - 40 or 60 mg PRAX-114 once daily in the evening
Double-blind Placebo
PLACEBO COMPARATORDouble-blind period - placebo once daily in the evening
Open-label Extension PRAX-114
EXPERIMENTALOpen-label extension period - 40 mg PRAX-114 once daily in the evening
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Praxis Research Site
Phoenix, Arizona, 85012, United States
Praxis Research Site
Little Rock, Arkansas, 72211, United States
Praxis Research Site
Rogers, Arkansas, 72758, United States
Praxis Research Site
Lemon Grove, California, 91945, United States
Praxis Research Site
Westlake Village, California, 91362, United States
Praxis Research Site
Fort Myers, Florida, 33908, United States
Praxis Research Site
Decatur, Georgia, 30030, United States
Praxis Research Site
Boston, Massachusetts, 02131, United States
Praxis Research Site
Las Vegas, Nevada, 89102, United States
Praxis Research Site
Cincinnati, Ohio, 45219, United States
Praxis Research Site
Dayton, Ohio, 45417, United States
Praxis Research Site
Oklahoma City, Oklahoma, 73118, United States
Praxis Research Site
Allentown, Pennsylvania, 18104, United States
Praxis Research Site
Media, Pennsylvania, 19063, United States
Praxis Research Site
Austin, Texas, 78737, United States
Praxis Research Site
Dallas, Texas, 75231, United States
Praxis Research Site
Everett, Washington, 98201, United States
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2022
First Posted
March 2, 2022
Study Start
January 25, 2022
Primary Completion
August 1, 2022
Study Completion
September 23, 2022
Last Updated
December 1, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share