Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)
NCT ID: NCT05401565
Last Updated: 2024-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
29 participants
INTERVENTIONAL
2022-08-02
2023-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Balovaptan
Balovaptan
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
Placebo
Placebo
Matching placebo
Interventions
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Balovaptan
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
Placebo
Matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
60 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Locations
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Alea Research
Phoenix, Arizona, United States
CITrials, Inc.
Bellflower, California, United States
ASCLEPES Research Centers
Panorama City, California, United States
Clinical Innovations, Inc
Santa Ana, California, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Galiz Research, LLC
Hialeah, Florida, United States
Florida International Research Center
Miami, Florida, United States
American Medical Research, Inc
Oak Brook, Illinois, United States
Boston Clinical Trials & Medical Research
Roslindale, Massachusetts, United States
Michigan Clinical Research Institute PC - Clinedge - PPDS
Ann Arbor, Michigan, United States
Va Medical Center
Minneapolis, Minnesota, United States
Alivation Research, LLC
Lincoln, Nebraska, United States
Bioscience Research, LLC
New York, New York, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Donald J. Garcia Jr., MD, PA
Austin, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BN43546
Identifier Type: -
Identifier Source: org_study_id
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