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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Drug: Placebo; Drug: Balovaptan

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: BN43546 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Alea Research
  • California
    • Bellflower, California, United States, 90706
      • CITrials, Inc.
    • Panorama City, California, United States, 91402
      • ASCLEPES Research Centers
    • Santa Ana, California, United States, 92705
      • Clinical Innovations, Inc
  • Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Hialeah, Florida, United States, 33016
      • Galiz Research, LLC
    • Miami, Florida, United States, 33173
      • Florida International Research Center
  • Illinois
    • Oak Brook, Illinois, United States, 60523
      • American Medical Research, Inc
  • Massachusetts
    • Roslindale, Massachusetts, United States, 02135
      • Boston Clinical Trials & Medical Research
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Michigan Clinical Research Institute PC - Clinedge - PPDS
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Va Medical Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Alivation Research, LLC
  • New York
    • New York, New York, United States, 10016
      • Bioscience Research, LLC
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Texas
    • Austin, Texas, United States, 78737
      • Donald J. Garcia Jr., MD, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo
Experimental: Balovaptan	Drug: Balovaptan; Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score	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.	From Baseline up to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score	The CGI-S reflects the rater's impression of the subject's current PTSD severity on a 6-point scale ranging from no symptoms (1) to very severe symptoms (6).	From Baseline up to Week 12
Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score	PHQ-9 is a 9-item PRO used to assess severity of depression. Responses are rated based on frequency of symptoms on a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). A total PHQ-9 total score ranging from 0 to 27 can be calculated by summing the nine items, of which a higher score corresponds to more severe depression.	From Baseline up to Week 12
Percentage of Participants With Adverse Events		From Baseline up to Week 12

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Actual): October 5, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: May 29, 2022
• First Submitted That Met QC Criteria: May 29, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Antidiuretic Hormone Receptor Antagonists; Balovaptan
• Other Study ID Numbers: BN43546

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No