Treatment of patients suffering of alcohol dependence and impaired liver function with Selincro® as-needed use
- Conditions
- Alcohol dependence and liver impairment related to alcohol consumptionMedDRA version: 17.1Level: LLTClassification code 10001594Term: Alcohol dependence syndromeSystem Organ Class: 100000004873MedDRA version: 17.1Level: LLTClassification code 10021520Term: Impaired liver functionSystem Organ Class: 100000004871Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2014-000413-31-DE
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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) <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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
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 <30 mL/min per 1.73 m2), and/or
- Transaminase levels above 5 times the upper limit of the reference range and ?GT levels above 10 times the upper limit of the reference range are not allowed unless if considered habitual for the patient by the Investigator, either confirmed by patient records or a repeat measurement during the Screening Period.
The patient has or has had one or more of the following conditions that is/are considered clinically relevant in the context of the study:
- seizure disorder or encephalopathy, and/or
- endocrine disorder : newly diagnosed or unstable diabetes I and II defined by:
o The patient has not previously been diagnosed with diabetes, but meets the following criteria (newly diagnosed diabetes):
- HbA1c >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 <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 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method