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Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation

NCT04035200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2023-09-18

Study results available
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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

DRUG

V117957 tablets

V117957 tablets taken orally at bedtime

DRUG

Placebo

Tablets to match V117957

Sponsors & Collaborators

  • Purdue Pharma LP

    collaborator INDUSTRY

  • Imbrium Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2020-11-06
Completion
2020-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04035200 on ClinicalTrials.gov