At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 114 enrolled
Drug / intervention
V117957 tablets +1 moredrug
Likely dose
Not stated in 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 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
In Brief
A Phase 2 clinical trial evaluating V117957 tablets and Placebo for Insomnia. Completed, enrolled 114 participants across 17 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States
CollaboratorsPurdue Pharma LP
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartSep 2019
Primary CompletionNov 2020
TodayJul 2026
First PostedJul 29, 2019
Enrollment StartSep 23, 2019
Primary CompletionNov 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.9 years ago
Interventions
V117957 tabletsdrug
V117957 tablets taken orally at bedtime
Placebodrug
Tablets to match V117957