Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use

NCT ID: NCT02197598

Last Updated: 2016-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30

Brief Summary

The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.

Conditions

Alcohol Dependence

Keywords

nalmefene, alcohol consumption, liver effects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Selincro® (nalmefene) 18 mg, tablets

One tablet orally for 12 weeks on days when the patient perceives a risk of drinking alcohol, preferably 1-2 hours prior to the anticipated risk of drinking.

Group Type: EXPERIMENTAL

nalmefene

Intervention Type: DRUG

Interventions

nalmefene

Intervention Type: DRUG

Other Intervention Names

Selincro®

Eligibility Criteria

Inclusion Criteria

• The patient has alcohol dependence, diagnosed at screening according to DSM-IV-TR™
• The patient has had an average alcohol consumption at, at least, a high drinking risk level (that is >60 g of alcohol/day for men and >40 g of alcohol/day for women) in the 4 weeks preceding the Screening Visit and in the period between the Screening and Inclusion Visits (that is, in the Screening Period)
• The patient has liver impairment defined by elevated liver stiffness and elevated liver enzymes at the Screening Visit (both criteria have to be fulfilled): liver stiffness (LS) as measured by Fibroscan >6 kPa, elevated transaminases (AST or ALT). Transaminase levels up to 5 times the upper limit of the reference range and γGT levels up to 10 times the upper limit of the reference range are allowed. At the discretion of the investigator, transaminase levels >5 times the upper limit of the reference range and γGT >10 times the upper limit of the reference range can be allowed if considered habitual for the patient, either confirmed by patient records or a repeat measurement during the Screening Period
• The patient has a breath alcohol concentration (BrAC) <0.02% at the Screening Visit.
• The patient provides a stable address and telephone number
• The patient is a man or woman, aged ≥ 18 years
• The patient has BMI≤30 kg/m2

Exclusion Criteria

• The patient has any psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than alcohol dependence assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview , that in any way will interfere with the ability of the patient to take part in the study
• The patient has reported current use of, or has been tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates)
• The patient has severe liver impairment classified with a Child-Pugh Score C
• The patient has one or more clinical laboratory test values outside the reference range, based on the blood and urine samples taken at the Screening Visit, that are of potential risk to the patient's safety, or the patient has: Severe renal impairment (eGFR <30 mL/min per 1.73 m2), and/or Hypercholesterolemia with serum cholesterol levels > 300 mg/dL, (>7,758 mmol/L), and/or bilirubin > 3 mg/dL (50 μmol/L)
• The patient has had <6 heavy drinking days (HDDs, defined by the European Medicines Agency as a day with an alcohol consumption >60 g for men or >40 g for women) in the 4 weeks preceding the Screening Visit
• The patient has >5 consecutive abstinence days in the 4 weeks preceding the Screening Visit
• The patient has a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H.Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

DE001

Heidelberg, , Germany

DE002

Mannheim, , Germany

Optuminisight

München, , Germany

Countries

Germany

Study Documents

Document Type: EMA EudraCT Results

View Document

Other Identifiers

2014-000413-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15871A

Identifier Type: -

Identifier Source: org_study_id