Post Traumatic Stress Disorder Clinical Trial
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
Verified date | November 2022 |
Source | Praxis Precision Medicines |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 11 |
Est. completion date | September 23, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Praxis Research Site | Allentown | Pennsylvania |
United States | Praxis Research Site | Austin | Texas |
United States | Praxis Research Site | Boston | Massachusetts |
United States | Praxis Research Site | Cincinnati | Ohio |
United States | Praxis Research Site | Dallas | Texas |
United States | Praxis Research Site | Dayton | Ohio |
United States | Praxis Research Site | Decatur | Georgia |
United States | Praxis Research Site | Everett | Washington |
United States | Praxis Research Site | Fort Myers | Florida |
United States | Praxis Research Site | Las Vegas | Nevada |
United States | Praxis Research Site | Lemon Grove | California |
United States | Praxis Research Site | Little Rock | Arkansas |
United States | Praxis Research Site | Media | Pennsylvania |
United States | Praxis Research Site | Oklahoma City | Oklahoma |
United States | Praxis Research Site | Phoenix | Arizona |
United States | Praxis Research Site | Rogers | Arkansas |
United States | Praxis Research Site | Westlake Village | California |
Lead Sponsor | Collaborator |
---|---|
Praxis Precision Medicines |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 15 days and 43 days | |
Secondary | 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). | 15 days, 29 days, and 43 days | |
Secondary | 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). | 15 days, 29 days, and 43 days | |
Secondary | 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. | 15 days, 29 days, and 43 days | |
Secondary | 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. | 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days | |
Secondary | 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. | 15 days, 29 days, 43 days | |
Secondary | 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). | 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days | |
Secondary | 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. | 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days |
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