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NCT05401565 · ClinicalTrials.gov registry record · Phase 2
Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT05401565: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT05401565 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05401565, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Balovaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2022-08-02 |
| Est. Completion | 2023-10-05 |
| Phase | Phase 2 |
What the finished NCT05401565 record still lists
NCT05401565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05401565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05401565 about?
NCT05401565 is a clinical study titled "Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder (PTSD)". 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.
What is the current status of trial NCT05401565?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2022-08-02. Estimated completion is 2023-10-05.
What interventions are being tested in trial NCT05401565?
The interventions under investigation include: Placebo (DRUG), Balovaptan (DRUG).
Who is sponsoring clinical trial NCT05401565?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05401565's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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