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Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Stress Disorders, Post-Traumatic

Interventions: Balovaptan, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (15)

Phoenix, Arizona, United States
Bellflower, California, United States
Panorama City, California, United States
Santa Ana, California, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Oak Brook, Illinois, United States
Roslindale, Massachusetts, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Lincoln, Nebraska, United States
New York, New York, United States
Mt. Pleasant, South Carolina, United States
Austin, Texas, United States