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

• Status: Not yet recruiting
• Trial end date: 2023-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

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