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Global
Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)
- Psychiatric Disorder
- Post Traumatic Stress Disorder
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Recruiting
This trial runs in
Cities
- Ann Arbor
- Gainesville
- Los Angeles
- Miami
- Miami Lakes
- New York
Trial Identifier:
NCT05401565 BN43546
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.
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT05401565,BN43546
Trial Identifier
Balovaptan, Placebo
Treatments
Stress Disorders, Post-Traumatic
Condition
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
Eligibility Criteria
All
Gender
≥18 Years & ≤ 60 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
For the latest version of this information please go to www.forpatients.roche.com