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NCT04035200 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
A Phase 2 study, sponsored by Imbrium Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
NCT04035200: Completed Phase 2 study, sponsored by Imbrium Therapeutics.
NCT04035200 is a Phase 2 study that has completed, run by Imbrium Therapeutics. The registered enrollment target is 114 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04035200, a Phase 2 study, has completed, sponsored by Imbrium Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with alcohol use disorder (AUD) who experience insomnia associated with alcohol cessation, compared to placebo.
Primary Outcome
Wakefulness After Sleep Onset, as measured by PSG, was defined as wake time after persistent sleep (wake time during sleep plus wake time after sleep, expressed in minutes). Nights 1 / 2 is the average of the PSG measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the PSG measurements taken during nights 20 and 21 of study drug exposure.
Interventions
- DRUG Placebo
- DRUG V117957 tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2019-09-23 |
| Est. Completion | 2020-11-06 |
| Phase | Phase 2 |
What the finished NCT04035200 record still lists
NCT04035200 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04035200 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04035200 about?
NCT04035200 is a clinical study titled "Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation". The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with alcohol use disorder (AUD) who experience insomnia associated with alcohol cessation, compared to placebo.
What is the current status of trial NCT04035200?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2019-09-23. Estimated completion is 2020-11-06.
What interventions are being tested in trial NCT04035200?
The interventions under investigation include: Placebo (DRUG), V117957 tablets (DRUG).
Who is sponsoring clinical trial NCT04035200?
This trial is sponsored by Imbrium Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04035200's enrollment target sits among peer trials
114 627th of 2000 higher than 1,370 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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