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

• ClinicalTrials.gov Identifier: NCT05401565
• Recruitment Status: Completed
• First Posted: June 2, 2022
• Results First Posted: April 18, 2024
• Last Update Posted: April 18, 2024
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stress Disorders, Post-Traumatic	Drug: Balovaptan; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: August 2, 2022
• Actual Primary Completion Date: October 5, 2023
• Actual Study Completion Date: October 5, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Arizona

Alea Research

Phoenix, Arizona, United States, 85012

United States, California

CITrials, Inc.

Bellflower, California, United States, 90706

ASCLEPES Research Centers

Panorama City, California, United States, 91402

Clinical Innovations, Inc

Santa Ana, California, United States, 92705

United States, Florida

Sarkis Clinical Trials

Gainesville, Florida, United States, 32607

Galiz Research, LLC

Hialeah, Florida, United States, 33016

Florida International Research Center

Miami, Florida, United States, 33173

United States, Illinois

American Medical Research, Inc

Oak Brook, Illinois, United States, 60523

United States, Massachusetts

Boston Clinical Trials & Medical Research

Roslindale, Massachusetts, United States, 02135

United States, Michigan

Michigan Clinical Research Institute PC - Clinedge - PPDS

Ann Arbor, Michigan, United States, 48105

United States, Minnesota

Va Medical Center

Minneapolis, Minnesota, United States, 55417

United States, Nebraska

Alivation Research, LLC

Lincoln, Nebraska, United States, 68526

United States, New York

Bioscience Research, LLC

New York, New York, United States, 10016

United States, South Carolina

Coastal Carolina Research Center

Mount Pleasant, South Carolina, United States, 29464

United States, Texas

Donald J. Garcia Jr., MD, PA

Austin, Texas, United States, 78737

Sponsors and Collaborators

Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol and Statistical Analysis Plan  [PDF] January 9, 2023

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT05401565
• Other Study ID Numbers: BN43546
• First Posted: June 2, 2022
• Results First Posted: April 18, 2024
• Last Update Posted: April 18, 2024
• Last Verified: March 2024

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Balovaptan; Antidiuretic Hormone Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Physiological Effects of Drugs