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

Alcohol Dependence Clinical Trial

Official title:

Exploratory, Interventional, Open-label, Fixed-dose Study With Selincro® As-needed Use, in Alcohol Dependent Patients With Liver Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197598
• Other study ID #: 15871A
• Secondary ID: 2014-000413-31
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2014
• Last updated: December 13, 2016
• Start date: September 2014

Study information

• Verified date: December 2016
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ?GT 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 ?GT >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)

Other protocol-defined inclusion and exclusion criteria may apply.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• nalmefene

Locations

Country	Name	City	State
Germany	DE001	Heidelberg
Germany	DE002	Mannheim
Germany	Optuminisight	München

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the number of heavy drinking days per month (HDDs) (days/month)		Baseline to months 1, 2 and 3	No
Primary	Change from baseline in the number of HDDs per week (days/week)		Baseline to weeks 1 and 2	No
Primary	Change from baseline in total alcohol consumption (TAC) (g alcohol/day)		Baseline to months 1, 2 and 3	No
Primary	Change from baseline in TAC (g alcohol/day)		Baseline to weeks 1 and 2	No
Primary	Response Shift Drinking Risk Level (RSDRL)	Defined as a downward shift from baseline in drinking risk level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or lower; for patients with a high DRL at baseline, a shift to low DRL or below	Baseline to month 3	No
Primary	Response Low Drinking Risk Level (RLDRL)	Defined as a downward shift from baseline in DRL to low DRL or below	Baseline to month 3	No
Primary	Response defined as =70% reduction in TAC		Baseline to month 3	No
Primary	Response defined as 0 to 4 HDDs (days/month)		Month 3	No
Primary	Clinical Global Impression, global improvement (CGI-I).		Weeks 4 and 12	No
Primary	Change from baseline in Clinical Global Impression, Severity of illness (CGI-S)		Baseline to weeks 4 and 12	No
Primary	Change in the Short-Form 36-Item Health Survey (SF-36)		Baseline to week 12	No
Primary	Change in liver stiffness		Baseline to weeks 1,2 4 and 12	No
Primary	Category shift in fibrosis stage		Baseline to weeks 1,2 4, and 12	No
Primary	Change in transaminases and ?-glutamyl transferase (?GT)		Baseline to weeks 1,2,4,8, and 12	No
Primary	Change in bilirubin, albumin, and International Normalized Ratio (INR)		Baseline to weeks 1,2,4,8, and 12	No
Primary	Number of adverse events		Screening to week 14	Yes