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

NCT05401565 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BN43546
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 15

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Balovaptan

EXPERIMENTAL

Drug: Balovaptan

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Balovaptan DRUG

Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period

Balovaptan

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

Alea Research

Phoenix, Arizona, 85012, United States

Location

CITrials, Inc.

Bellflower, California, 90706, United States

Location

ASCLEPES Research Centers

Panorama City, California, 91402, United States

Location

Clinical Innovations, Inc

Santa Ana, California, 92705, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Galiz Research, LLC

Hialeah, Florida, 33016, United States

Location

Florida International Research Center

Miami, Florida, 33173, United States

Location

American Medical Research, Inc

Oak Brook, Illinois, 60523, United States

Location

Boston Clinical Trials & Medical Research

Roslindale, Massachusetts, 02135, United States

Location

Michigan Clinical Research Institute PC - Clinedge - PPDS

Ann Arbor, Michigan, 48105, United States

Location

Va Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Alivation Research, LLC

Lincoln, Nebraska, 68526, United States

Location

Bioscience Research, LLC

New York, New York, 10016, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Donald J. Garcia Jr., MD, PA

Austin, Texas, 78737, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

balovaptan

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 2, 2022
• Study Start: August 2, 2022
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-03

Locations

US (15)