Clinical trial NCT05260541: A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Post-traumatic Stress Disorder
Post Traumatic Stress Disorder
Stress Disorder
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorder
Keywords: Agents, GABA
Receptors, GABA-A
Allosteric Regulation
PRAX-114
Lead sponsor: Praxis Precision Medicines
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score at Day 29
timeFrame: 29 days
Secondary outcomes:
measure: Change from baseline in the CAPS-5 total score at Day 15 and 43
timeFrame: 15 days and 43 days
measure: Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 29, Day 15, and Day 43
timeFrame: 15 days, 29 days, and 43 days
measure: Change from baseline in Clinical Global Impression-Improvement (CGI-I) score at Day 29, Day 15, and Day 43
timeFrame: 15 days, 29 days, and 43 days
measure: Change from baseline in the CAPS-5 symptom cluster scores at Day 29, Day 15, and Day 43
timeFrame: 15 days, 29 days, and 43 days
measure: Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) at Day 29, Day 15, and all other timepoints
timeFrame: 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
measure: Change from baseline in the Sheehan Disability Scale (SDS) at Day 29, Day 15, and Day 43
timeFrame: 15 days, 29 days, 43 days
measure: Patient Global Impression-Improvement (PGI-I) score at Day 29, Day 15 and all other time points
timeFrame: 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
measure: Change from baseline in the Insomnia Severity Index (ISI) at Day 29, Day 15, and all other timepoints
timeFrame: 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Praxis Research Site
state: Arizona
city: Little Rock
country: United States
facility: Praxis Research Site
state: Arkansas
city: Rogers
country: United States
facility: Praxis Research Site
state: Arkansas
city: Lemon Grove
country: United States
facility: Praxis Research Site
state: California
city: Westlake Village
country: United States
facility: Praxis Research Site
state: California
city: Fort Myers
country: United States
facility: Praxis Research Site
state: Florida
city: Decatur
country: United States
facility: Praxis Research Site
state: Georgia
city: Boston
country: United States
facility: Praxis Research Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Praxis Research Site
state: Nevada
city: Cincinnati
country: United States
facility: Praxis Research Site
state: Ohio
city: Dayton
country: United States
facility: Praxis Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Praxis Research Site
state: Oklahoma
city: Allentown
country: United States
facility: Praxis Research Site
state: Pennsylvania
city: Media
country: United States
facility: Praxis Research Site
state: Pennsylvania
city: Austin
country: United States
facility: Praxis Research Site
state: Texas
city: Dallas
country: United States
facility: Praxis Research Site
state: Texas
city: Everett
country: United States
facility: Praxis Research Site
state: Washington
Study officials:
References: