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

Roche

Status and phase

Completed

Phase 2

Conditions

Stress Disorders, Post-Traumatic

Treatments

Drug: Balovaptan

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05401565

BN43546

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18 to 60 years old

Volunteers

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