A Study of MK0594 in Patients With Alcohol Dependence (0594-020)

May 18, 2021 updated by: Vyne Therapeutics Inc.

A Phase II Multicenter, Randomized, Double-Blind, Two-Stage Clinical Trial to Evaluate the Efficacy and Safety of MK0594 in Patients With Alcohol Dependence

A study in patients with alcohol dependence to see if MK0594 is safe and effective in maintaining absence of heavy drinking over a 12-week treatment period.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision diagnosis of alcohol dependence and alcohol addiction
  • Patient has two heavy drinking days in the last 30 days
  • Patient has 3 days of abstinence from alcohol right before taking study medication
  • Patient has lived in the same residence for the last 2 months

Exclusion Criteria:

  • If female, patient is pregnant or breastfeeding
  • Patient anticipated inpatient alcohol treatment
  • Patient has a history of suicide attempt in the last year
  • Patient has schizophrenia or bipolar disorder
  • Patient has a history of multiple or serious allergies
  • Patient has participated in a clinical trial in the last 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stage I, Arm 1
MK0594 5 mg/day
Drug: Comparator: MK0594 5 mg/day
MK0594 5 mg tablets taken orally once daily for 12 weeks. At the randomization visit, a loading dose of 15 mg MK0594 will be administered.
PLACEBO_COMPARATOR: Stage I, Arm 2
Placebo
Drug: Comparator: Placebo to MK0594
Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.
EXPERIMENTAL: Stage II, Arm 2
MK0594 1 mg/day
Drug: Comparator: MK0594 1 mg/day
MK0594 1 mg tablets taken orally once daily for 12 weeks. At the randomization visit, a loading dose of 3 mg MK0594 will be administered.
EXPERIMENTAL: Stage II, Arm 3
MK0594 1 mg/week
Drug: Comparator: MK0594 1 mg/week
MK0594 1 mg tablets taken orally once every 7 days for 12 weeks. At the randomization visit, a loading dose of 3 mg MK0594 will be administered.
PLACEBO_COMPARATOR: Stage II, Arm 4
Placebo
Drug: Comparator: Placebo to MK0594
Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination
Time Frame: week 3 and 12 after starting study medication for efficacy and over 12 weeks and 52 weeks for safety
no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination
week 3 and 12 after starting study medication for efficacy and over 12 weeks and 52 weeks for safety

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
no alcohol drinking
Time Frame: week 3 to 12 after starting study medication and over 52 weeks
no alcohol drinking
week 3 to 12 after starting study medication and over 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vyne Therapeutics Inc.

Investigators

  • Study Director: Menlo Therapeutics Inc., Menlo Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 27, 2009

Primary Completion (ACTUAL)

March 11, 2010

Study Completion (ACTUAL)

March 11, 2010

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (ESTIMATE)

February 4, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0594-020
  • MK0594-020
  • 2009_533

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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