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

Stress Disorders, Post-Traumatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05401565
• Other study ID #: BN43546
• Status: Completed
• Phase: Phase 2
• Start date: August 2, 2022
• Est. completion date: October 5, 2023

Study information

• Verified date: March 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 5, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Balovaptan
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Michigan Clinical Research Institute PC - Clinedge - PPDS	Ann Arbor	Michigan
United States	Donald J. Garcia Jr., MD, PA	Austin	Texas
United States	CITrials, Inc.	Bellflower	California
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Galiz Research, LLC	Hialeah	Florida
United States	Alivation Research, LLC	Lincoln	Nebraska
United States	Florida International Research Center	Miami	Florida
United States	Va Medical Center	Minneapolis	Minnesota
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Bioscience Research, LLC	New York	New York
United States	American Medical Research, Inc	Oak Brook	Illinois
United States	ASCLEPES Research Centers	Panorama City	California
United States	Alea Research	Phoenix	Arizona
United States	Boston Clinical Trials & Medical Research	Roslindale	Massachusetts
United States	Clinical Innovations, Inc	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Percentage of Participants With Adverse Events		From Baseline up to Week 12