Alcohol dependence and liver impairment related to alcohol consumption MedDRA version: 17.1 Level: LLT Classification code 10001594 Term: Alcohol dependence syndrome System Organ Class: 100000004873 MedDRA version: 17.1 Level: LLT Classification code 10021520 Term: Impaired liver function System Organ Class: 100000004871
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion 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 changes defined by elevated liver stiffness or elevated controlled attenuation parameter (CAP) at the Screening Visit. - liver stiffness (LS) >6 kPa or CAP >215 dB/m measured by Fibroscan The patient has a breath alcohol concentration (BrAC) =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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, see Panel 4 of the protocol. 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 6.5% AND - Fasting plasma glucose >126 mg/dL (7.0 mmol/L) If only one parameter is abnormal a retest is mandatory. A new abnormal result is considered as an exclusion. OR o The patient has previously been diagnosed with diabetes, but the condition is unstable as determined by the following criteria - HbA1c >8.0 % - The patient has had 60 g for men or >40 g for women) 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). - The patient is, in the opinion of the investigator, at significant risk of suicide - The patient is currently participating in or has recently completed (within 1 month prior to the Screening Visit) a treatment or support programme for alcohol-use disorders, including Alcohol Anonymous, (participation in a self-support group is allowed), detoxification treatment, and treatment of alcohol withdrawal symptoms - The patient’s immediate treatment goal is abstinence. - The patient has physical withdrawal symptoms and requires immediate detoxification
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Exploratory objectives to be assessed in patients with alcohol dependence and liver impairment treated with 18 mg Selincro® (nalmefene), as-needed, over 12 weeks: - To explore the reduction of alcohol consumption - To explore the change in liver stiffness - To explore the change in Controlled Attenuation Parameter (CAP) - To explore the change in liver enzymes - To explore the shift in fibrosis stage - To explore the associations between reduction of alcohol consumption, liver stiffness, CAP and liver enzymes To explore the change in patients with alcohol dependence and liver impairment treated with 18 mg Selincro® (nalmefene), as-needed, on: - Clinical Global Impression - Quality of life Safety objective: To evaluate safety and tolerability of 18 mg Selincro® (nalmefene), as-needed, in patients with alcohol dependence and liver impairment;Secondary Objective: Not applicable;Primary end point(s): ? The therapeutic effect on the reduction of alcohol consumption will be evaluated by - change from baseline in the number of heavy drinking days (HDDs) - change from baseline in total alcohol consumption (TAC) - Response Shift Drinking Risk Level (RSDRL) response: 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 - Response Low Drinking Risk Level (RLDRL) response: defined as a downward shift from baseline in DRL to low DRL or below - response defined as =70% reduction in TAC - response defined as 0 to 4 HDDs (days/month) ? The therapeutic effect on the change in liver stiffness will be evaluated by measurement of liver stiffness and category shift in fibrosis stage. ? The therapeutic effect on the change in controlled attenuation parameter (CAP) will be evaluated by measurement of CAP and category shift in steatosis stage. ? The therapeutic effect on liver function will be evaluat | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Germany
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed