Trials / Completed
CompletedNCT04035200
Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of V117957 in Subjects With an Alcohol Use Disorder Who Are Experiencing Insomnia Associated With Alcohol Cessation
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Imbrium Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | V117957 tablets | V117957 tablets taken orally at bedtime |
| DRUG | Placebo | Tablets to match V117957 |
Timeline
- Start date
- 2019-09-23
- Primary completion
- 2020-11-06
- Completion
- 2020-11-06
- First posted
- 2019-07-29
- Last updated
- 2023-09-18
- Results posted
- 2023-09-18
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04035200. Inclusion in this directory is not an endorsement.