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

NCT00835718 | Terminated Phase 2 FDA Drug

• 3 other identifiers: 0594-020MK0594-0202009_533
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

• no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination

  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 Outcomes (1)

• no alcohol drinking

  week 3 to 12 after starting study medication and over 52 weeks

Study Arms (5)

Stage I, Arm 1

EXPERIMENTAL

MK0594 5 mg/day

Drug: Comparator: MK0594 5 mg/day

Stage I, Arm 2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo to MK0594

Stage II, Arm 2

EXPERIMENTAL

MK0594 1 mg/day

Drug: Comparator: MK0594 1 mg/day

Stage II, Arm 3

EXPERIMENTAL

MK0594 1 mg/week

Drug: Comparator: MK0594 1 mg/week

Stage II, Arm 4

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo to MK0594

Interventions

Comparator: MK0594 5 mg/day DRUG

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.

Stage I, Arm 1

Comparator: MK0594 1 mg/day DRUG

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.

Stage II, Arm 2

Comparator: MK0594 1 mg/week DRUG

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.

Stage II, Arm 3

Comparator: Placebo to MK0594 DRUG

Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.

Stage I, Arm 2; Stage II, Arm 4

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Menlo Therapeutics Inc.

  Vyne Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: February 27, 2009
• Primary Completion: March 11, 2010
• Study Completion: March 11, 2010
• Last Updated: May 20, 2021

Record last verified: 2021-05