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

Hoffmann-La Roche15 sites in 1 country29 target enrollmentAugust 2, 2022

ConditionsStress Disorders, Post-Traumatic

InterventionsBalovaptan Placebo

DrugsBalovaptan Placebo

Overview

Phase: Phase 2
Intervention: Balovaptan
Conditions: Stress Disorders, Post-Traumatic
Sponsor: Hoffmann-La Roche
Enrollment: 29
Locations: 15
Primary Endpoint: Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2, 2022

End Date

October 5, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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

Arms & Interventions

Balovaptan

Intervention: Balovaptan

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score

Time Frame: From Baseline up to Week 12

The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. Measured 3 times over 12 weeks.

Secondary Outcomes

Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score(From Baseline up to Week 12)
Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score(From Baseline up to Week 12)
Percentage of Participants With Adverse Events(From Baseline up to Week 12)