Clinical trial NCT05401565: Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2022-06-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score
timeFrame: From Baseline up to Week 12
Secondary outcomes:
measure: Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score
timeFrame: From Baseline up to Week 12
measure: Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score
timeFrame: From Baseline up to Week 12
measure: Percentage of Participants With Adverse Events
timeFrame: From Baseline up to Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Alea Research
state: Arizona
city: Bellflower
country: United States
facility: CITrials, Inc.
state: California
city: Panorama City
country: United States
facility: ASCLEPES Research Centers
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations, Inc
state: California
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Galiz Research, LLC
state: Florida
city: Miami
country: United States
facility: Florida International Research Center
state: Florida
city: Oak Brook
country: United States
facility: American Medical Research, Inc
state: Illinois
city: Roslindale
country: United States
facility: Boston Clinical Trials & Medical Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Clinical Research Institute PC - Clinedge - PPDS
state: Michigan
city: Minneapolis
country: United States
facility: Va Medical Center
state: Minnesota
city: Lincoln
country: United States
facility: Alivation Research, LLC
state: Nebraska
city: New York
country: United States
facility: Bioscience Research, LLC
state: New York
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: Donald J. Garcia Jr., MD, PA
state: Texas
Study officials:
References: