NCT05401565

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
DRUG	Balovaptan	Intervention of oral administration of 10mg balovaptan QD for 12 weeks followed by two weeks of follow-up period
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2022-08-02
• Primary completion: 2023-10-05
• Completion: 2023-10-05
• First posted: 2022-06-02
• Last updated: 2024-04-18
• Results posted: 2024-04-18

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study