Stress Disorders, Post-TraumaticPhase 2NCT05401565
Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)
A Phase 2 study testing Balovaptan in people with Stress Disorders, Post-Traumatic, run by Hoffmann-La Roche at 15 sites in United States.
Trial summary
This study will evaluate the efficacy and safety of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults with PTSD. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Balovaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 15 sitesUnited States
- Study dates
- 2 Aug 2022to 5 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants who have a current diagnosis of PTSD as per DSM-5 criteria, with a score of >/=33 on the PCL-5 at screening
- The index trauma event must have occurred in adulthood, i.e., when the participant was >/=18 years old
- The index trauma event must have occurred at least 6 months prior to screening and no more than 10 years prior to screening
- At baseline, either taking a stable dose of a single antidepressant (SSRI or SNRI) for management of PTSD and have been on that medication for >/=6 weeks at that stable dosage and demonstrating residual symptoms of PTSD or prior demonstrated lack of tolerability or lack of efficacy and not taking an antidepressant medication at baseline for >/=6 weeks
- Treatment with permitted medications and/or non-pharmacological interventions at a stable dose for 6 weeks prior to screening
- For women of childbearing potential: agreement to remain abstinent or use contraception
Who cannot join
- Participants who are experiencing ongoing exposure to traumatic events within 3 months of screening
- Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days after the final dose of study drug
- Clinically significant psychiatric and/or neurological conditions, which may interfere with the assessment of safety or efficacy endpoints
- Substance use disorders during last 12 months
- Significant risk for suicidal behaviour
- Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
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- Clinical diagnosis of peripheral neuropathy
- Within the last 2 years, unstable or clinically significant cardiovascular disorders
- Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
- Moderate or severe hepatic or renal impairment
- History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression (including iatrogenic)
- Medical history of malignancy, if not considered cured
- Participants who have received treatment with investigational therapy within 8 weeks prior to randomization
- Known hypersensitivity to balovaptan, its components, or any of the excipients used in the formulation
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Michigan Clinical Research Institute PC - Clinedge - PPDS
Ann Arbor, Michigan, 48105
Donald J. Garcia Jr., MD, PA
Austin, Texas, 78737
CITrials, Inc.
Bellflower, California, 90706
Sarkis Clinical Trials
Gainesville, Florida, 32607
Galiz Research, LLC
Hialeah, Florida, 33016
Alivation Research, LLC
Lincoln, Nebraska, 68526
Florida International Research Center
Miami, Florida, 33173
Va Medical Center
Minneapolis, Minnesota, 55417
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Bioscience Research, LLC
New York, New York, 10016
American Medical Research, Inc
Oak Brook, Illinois, 60523
ASCLEPES Research Centers
Panorama City, California, 91402
Alea Research
Phoenix, Arizona, 85012
Boston Clinical Trials & Medical Research
Roslindale, Massachusetts, 02135
Clinical Innovations, Inc
Santa Ana, California, 92705
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Multicenter Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder
This study will evaluate the efficacy and safety of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults with PTSD.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Balovaptan, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalovaptanDrug
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Balovaptan | Experimental | Not described Receives: Drug: Balovaptan |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
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 Total Symptom Severity Score
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. Measured 3 times over 12 weeks.
Measured: From Baseline up to Week 12
Secondary outcomes (3)
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
The CGI-S reflects the rater's impression of the subject's current PTSD severity on a 6-point scale ranging from no symptoms (1) to very severe symptoms (6).
Measured: From Baseline up to Week 12
Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score
PHQ-9 is a 9-item PRO used to assess severity of depression. Responses are rated based on frequency of symptoms on a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). A total PHQ-9 total score ranging from 0 to 27 can be calculated by summing the nine items, of which a higher score corresponds to more severe depression.
Measured: From Baseline up to Week 12
Percentage of Participants With Adverse Events
Measured: From Baseline up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start2 Aug 2022
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401565
- Sponsor's protocol ID
- BN43546
- Status last verified
- Mar 2024
- First submitted
- 29 May 2022
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Multicenter Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT05401565
- Acronym / sponsor ID
- BN43546
- Conditions
- Stress Disorders, Post-Traumatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults with PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balovaptan | Experimental | Drug: Balovaptan |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants who have a current diagnosis of PTSD as per DSM-5 criteria, with a score of >/=33 on the PCL-5 at screening
- The index trauma event must have occurred in adulthood, i.e., when the participant was >/=18 years old
- The index trauma event must have occurred at least 6 months prior to screening and no more than 10 years prior to screening
- At baseline, either taking a stable dose of a single antidepressant (SSRI or SNRI) for management of PTSD and have been on that medication for >/=6 weeks at that stable dosage and demonstrating residual symptoms of PTSD or prior demonstrated lack of tolerability or lack of efficacy and not taking an antidepressant medication at baseline for >/=6 weeks
- Treatment with permitted medications and/or non-pharmacological interventions at a stable dose for 6 weeks prior to screening
Key exclusion criteria (14 listed)
- Participants who are experiencing ongoing exposure to traumatic events within 3 months of screening
- Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days after the final dose of study drug
- Clinically significant psychiatric and/or neurological conditions, which may interfere with the assessment of safety or efficacy endpoints
- Substance use disorders during last 12 months
- Significant risk for suicidal behaviour
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 |
|---|---|---|
| BalovaptanIntervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period | Drug | Balovaptan |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score
Time frame: From Baseline up to Week 12
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. Measured 3 times over 12 weeks.
3 secondary outcomes
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
Time frame: From Baseline up to Week 12
Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score
Time frame: From Baseline up to Week 12
Percentage of Participants With Adverse Events
Time frame: From Baseline up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
15 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 Balovaptan in people with Stress Disorders, Post-Traumatic, run by Hoffmann-La Roche at 15 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 6 inclusion and 14 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: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Total Symptom Severity Score (time frame: From Baseline up to Week 12). 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 18 Apr 2024.