Post-traumatic Stress DisorderPhase 2NCT05260541
A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder
A Phase 2 study testing 60 mg PRAX-114 or 40 mg PRAX-114 and 40 mg PRAX-114 in people with Post-traumatic Stress Disorder and Post Traumatic Stress Disorder, run by Praxis Precision Medicines at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-traumatic Stress Disorder, Post Traumatic Stress Disorder, Stress Disorder
- What is being tested?
- 60 mg PRAX-114 or 40 mg PRAX-114 and 40 mg PRAX-114
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 17 sitesUnited States
- Study dates
- 25 Jan 2022to 23 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Praxis Research Site
Allentown, Pennsylvania, 18104
Praxis Research Site
Austin, Texas, 78737
Praxis Research Site
Boston, Massachusetts, 02131
Praxis Research Site
Cincinnati, Ohio, 45219
Praxis Research Site
Dallas, Texas, 75231
Praxis Research Site
Dayton, Ohio, 45417
Praxis Research Site
Decatur, Georgia, 30030
Praxis Research Site
Everett, Washington, 98201
Praxis Research Site
Fort Myers, Florida, 33908
Praxis Research Site
Las Vegas, Nevada, 89102
Praxis Research Site
Lemon Grove, California, 91945
Praxis Research Site
Little Rock, Arkansas, 72211
Praxis Research Site
Media, Pennsylvania, 19063
Praxis Research Site
Oklahoma City, Oklahoma, 73118
Praxis Research Site
Phoenix, Arizona, 85012
Praxis Research Site
Rogers, Arkansas, 72758
Praxis Research Site
Westlake Village, California, 91362
About this study
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
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.
- Conditions
- Post-traumatic Stress Disorder, Post Traumatic Stress Disorder, Stress Disorder, Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Mental Disorder
- Being tested
- 60 mg PRAX-114 or 40 mg PRAX-114, Placebo, 40 mg PRAX-114
- Keywords
- Agents, GABA, Receptors, GABA-A, Allosteric Regulation, PRAX-114
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Trauma and Stressor Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60 mg PRAX-114 or 40 mg PRAX-114Drug
Once daily oral treatment for 4 weeks
PlaceboDrug
Once daily oral treatment for 4 weeks
40 mg PRAX-114Drug
Once daily oral treatment for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Double-blind PRAX-114 | Experimental | Double-blind period - 40 or 60 mg PRAX-114 once daily in the evening Receives: Drug: 60 mg PRAX-114 or 40 mg PRAX-114 |
| Double-blind Placebo | Placebo comparator | Double-blind period - placebo once daily in the evening Receives: Drug: Placebo |
| Open-label Extension PRAX-114 | Experimental | Open-label extension period - 40 mg PRAX-114 once daily in the evening Receives: Drug: 40 mg PRAX-114 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 29 days
Secondary outcomes (8)
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.
Measured: 15 days and 43 days
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).
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
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.
Measured: 15 days, 29 days, 43 days
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).
Measured: 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
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.
Measured: 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start25 Jan 2022
- Primary completion1 Aug 2022
- Study completion23 Sep 2022
Why it stopped: No longer developing for this indication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Praxis Precision Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260541
- Sponsor's protocol ID
- PRAX-114-221
- Status last verified
- Nov 2022
- First submitted
- 18 Feb 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05260541
- Acronym / sponsor ID
- PRAX-114-221
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer developing for this indication
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Praxis Precision MedicinesIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double-blind PRAX-114 | Experimental | Drug: 60 mg PRAX-114 or 40 mg PRAX-114Double-blind period - 40 or 60 mg PRAX-114 once daily in the evening |
| Double-blind Placebo | Placebo comparator | Drug: PlaceboDouble-blind period - placebo once daily in the evening |
| Open-label Extension PRAX-114 | Experimental | Drug: 40 mg PRAX-114Open-label extension period - 40 mg PRAX-114 once daily in the evening |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 60 mg PRAX-114 or 40 mg PRAX-114Once daily oral treatment for 4 weeks | Drug | Double-blind PRAX-114 |
| PlaceboOnce daily oral treatment for 4 weeks | Drug | Double-blind Placebo |
| 40 mg PRAX-114Once daily oral treatment for 8 weeks | Drug | Open-label Extension PRAX-114 |
Primary outcome
Change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score at Day 29
Time frame: 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.
8 secondary outcomes
Change from baseline in the CAPS-5 total score at Day 15 and 43
Time frame: 15 days and 43 days
Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 29, Day 15, and Day 43
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
Change from baseline in the Sheehan Disability Scale (SDS) at Day 29, Day 15, and Day 43
Time frame: 15 days, 29 days, 43 days
Patient Global Impression-Improvement (PGI-I) score at Day 29, Day 15 and all other time points
Time frame: 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
Change from baseline in the Insomnia Severity Index (ISI) at Day 29, Day 15, and all other timepoints
Time frame: 8 days, 15 days, 22 days, 29 days, 35 days, and 43 days
Results and safety
The study was stopped early (reason given: No longer developing for this indication). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 60 mg PRAX-114 or 40 mg PRAX-114 and 40 mg PRAX-114 in people with Post-traumatic Stress Disorder and Post Traumatic Stress Disorder, run by Praxis Precision Medicines at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No longer developing for this indication). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score at Day 29 (time frame: 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.