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

Sponsor
Praxis Precision Medicines (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05260541
Collaborator
(none)
80
Enrollment
5
Locations
3
Arms
12.2
Anticipated Duration (Months)
16
Patients Per Site
1.3
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 DiseaseIntervention/TreatmentPhase
  • Drug: 60 mg PRAX-114 or 40 mg PRAX-114
  • Drug: Placebo
  • Drug: 40 mg PRAX-114
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 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

ArmIntervention/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

  1. 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

  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Praxis Research SitePhoenixArizonaUnited States85012
2Praxis Research SiteLas VegasNevadaUnited States89102
3Praxis Research SiteMediaPennsylvaniaUnited States19063
4Praxis Research SiteAustinTexasUnited States78737
5Praxis Research SiteEverettWashingtonUnited States98201

Sponsors and Collaborators

  • Praxis Precision Medicines

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Praxis Precision Medicines
ClinicalTrials.gov Identifier:
NCT05260541
Other Study ID Numbers:
  • PRAX-114-221
First Posted:
Mar 2, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Praxis Precision Medicines
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022