Status:
COMPLETED
Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05401565
Start Date
August 2 2022
End Date
October 5 2023
Last Update
April 18 2024
Active Locations (15)
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1
Alea Research
Phoenix, Arizona, United States, 85012
2
CITrials, Inc.
Bellflower, California, United States, 90706
3
ASCLEPES Research Centers
Panorama City, California, United States, 91402
4
Clinical Innovations, Inc
Santa Ana, California, United States, 92705