Back to resultsA Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder
Primary Purpose
Post-traumatic Stress Disorder, Post Traumatic Stress Disorder, Stress Disorder
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
60 mg PRAX-114 or 40 mg PRAX-114
Placebo
40 mg PRAX-114
Sponsored by
About this trial
This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring Agents, GABA, Receptors, GABA-A, Allosteric Regulation, PRAX-114
Eligibility Criteria
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.
Sites / Locations
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Double-blind PRAX-114
Double-blind Placebo
Open-label Extension PRAX-114
Arm Description
Double-blind period - 40 or 60 mg PRAX-114 once daily in the evening
Double-blind period - placebo once daily in the evening
Open-label extension period - 40 mg PRAX-114 once daily in the evening
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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).
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.
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.
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.
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).
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.
Full Information
NCT ID
NCT05260541
First Posted
February 18, 2022
Last Updated
November 28, 2022
Sponsor
Praxis Precision Medicines
1. Study Identification
Unique Protocol Identification Number
NCT05260541
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
No longer developing for this indication
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Praxis Precision Medicines
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Double-blind PRAX-114
Arm Type
Experimental
Arm Description
Double-blind period - 40 or 60 mg PRAX-114 once daily in the evening
Arm Title
Double-blind Placebo
Arm Type
Placebo Comparator
Arm Description
Double-blind period - placebo once daily in the evening
Arm Title
Open-label Extension PRAX-114
Arm Type
Experimental
Arm Description
Open-label extension period - 40 mg PRAX-114 once daily in the evening
Intervention Type
Drug
Intervention Name(s)
60 mg PRAX-114 or 40 mg PRAX-114
Intervention Description
Once daily oral treatment for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily oral treatment for 4 weeks
Intervention Type
Drug
Intervention Name(s)
40 mg PRAX-114
Intervention Description
Once daily oral treatment for 8 weeks
Primary Outcome Measure Information:
Title
Change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score at Day 29
Description
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.
Time Frame
29 days
Secondary Outcome Measure Information:
Title
Change from baseline in the CAPS-5 total score at Day 15 and 43
Description
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.
Time Frame
15 days and 43 days
Title
Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 29, Day 15, and Day 43
Description
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).
Time Frame
15 days, 29 days, and 43 days
Title
Change from baseline in Clinical Global Impression-Improvement (CGI-I) score at Day 29, Day 15, and Day 43
Description
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).
Time Frame
15 days, 29 days, and 43 days
Title
Change from baseline in the CAPS-5 symptom cluster scores at Day 29, Day 15, and Day 43
Description
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.
Time Frame
15 days, 29 days, and 43 days
Title
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) at Day 29, Day 15, and all other timepoints
Description
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.
Time Frame
8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
Title
Change from baseline in the Sheehan Disability Scale (SDS) at Day 29, Day 15, and Day 43
Description
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.
Time Frame
15 days, 29 days, 43 days
Title
Patient Global Impression-Improvement (PGI-I) score at Day 29, Day 15 and all other time points
Description
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).
Time Frame
8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
Title
Change from baseline in the Insomnia Severity Index (ISI) at Day 29, Day 15, and all other timepoints
Description
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.
Time Frame
8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Praxis Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Praxis Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Praxis Research Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Praxis Research Site
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Praxis Research Site
City
Westlake Village
State/Province
California
ZIP/Postal Code
91362
Country
United States
Facility Name
Praxis Research Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Praxis Research Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Praxis Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Praxis Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Praxis Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Praxis Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Praxis Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Praxis Research Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Praxis Research Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Praxis Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Praxis Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Praxis Research Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder
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