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

Phase 2

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Balovaptan	Balovaptan	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score	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

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

Locations (15): CITrials, Inc.
🇺🇸
Bellflower, California, United States
ASCLEPES Research Centers
🇺🇸
Panorama City, California, United States
Clinical Innovations, Inc
🇺🇸
Santa Ana, California, United States
American Medical Research, Inc
🇺🇸
Oak Brook, Illinois, United States
Bioscience Research, LLC
🇺🇸
New York, New York, United States
Galiz Research, LLC
🇺🇸
Hialeah, Florida, United States
Coastal Carolina Research Center
🇺🇸
Mount Pleasant, South Carolina, United States
Boston Clinical Trials & Medical Research
🇺🇸
Roslindale, Massachusetts, United States
Alivation Research, LLC
🇺🇸
Lincoln, Nebraska, United States
Alea Research
🇺🇸
Phoenix, Arizona, United States
Sarkis Clinical Trials
🇺🇸
Gainesville, Florida, United States
Florida International Research Center
🇺🇸
Miami, Florida, United States
Donald J. Garcia Jr., MD, PA
🇺🇸
Austin, Texas, United States
Michigan Clinical Research Institute PC - Clinedge - PPDS
🇺🇸
Ann Arbor, Michigan, United States
Va Medical Center
🇺🇸
Minneapolis, Minnesota, United States