At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
Balovaptan +1 moredrug
Likely dose
Balovaptan 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Balovaptan and Placebo for Stress Disorders, Post-Traumatic. Completed, enrolled 29 participants across 15 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Disorders, Post-Traumatic
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedJun 2022
Enrollment StartAug 2022
Primary CompletionOct 2023
TodayJul 2026
First PostedJun 2, 2022
Enrollment StartAug 2, 2022
Primary CompletionOct 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.1 years ago
Interventions
Balovaptandrug
Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
Placebodrug
Matching placebo