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Trial record 6 of 11 for:    balovaptan

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05401565
Recruitment Status : Completed
First Posted : June 2, 2022
Results First Posted : April 18, 2024
Last Update Posted : April 18, 2024
Information provided by (Responsible Party):
Hoffmann-La Roche

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

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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

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05401565

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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs