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Completed

NCT Number: NCT02197598

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

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

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Key information

Conditions

Alcohol Dependence Alcohol Drinking Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

DE001, Heidelberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Other protocol-defined inclusion and exclusion criteria may apply.

Treatment and study plan

Nalmefene

Drug

Other names: Selincro®

Primary outcomes

  1. Change from baseline in the number of heavy drinking days per month (HDDs) (days/month)

    Time frame: Baseline to months 1, 2 and 3

  2. Change from baseline in the number of HDDs per week (days/week)

    Time frame: Baseline to weeks 1 and 2

  3. Change from baseline in total alcohol consumption (TAC) (g alcohol/day)

    Time frame: Baseline to months 1, 2 and 3

  4. Change from baseline in TAC (g alcohol/day)

    Time frame: Baseline to weeks 1 and 2

  5. Response Shift Drinking Risk Level (RSDRL)

    Time frame: Baseline to month 3

    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

  6. Response Low Drinking Risk Level (RLDRL)

    Time frame: Baseline to month 3

    Defined as a downward shift from baseline in DRL to low DRL or below

  7. Response defined as ≥70% reduction in TAC

    Time frame: Baseline to month 3

  8. Response defined as 0 to 4 HDDs (days/month)

    Time frame: Month 3

  9. Clinical Global Impression, global improvement (CGI-I).

    Time frame: Weeks 4 and 12

  10. Change from baseline in Clinical Global Impression, Severity of illness (CGI-S)

    Time frame: Baseline to weeks 4 and 12

  11. Change in the Short-Form 36-Item Health Survey (SF-36)

    Time frame: Baseline to week 12

  12. Change in liver stiffness

    Time frame: Baseline to weeks 1,2 4 and 12

  13. Category shift in fibrosis stage

    Time frame: Baseline to weeks 1,2 4, and 12

  14. Change in transaminases and γ-glutamyl transferase (γGT)

    Time frame: Baseline to weeks 1,2,4,8, and 12

  15. Change in bilirubin, albumin, and International Normalized Ratio (INR)

    Time frame: Baseline to weeks 1,2,4,8, and 12

  16. Number of adverse events

    Time frame: Screening to week 14

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
First posted
Jul 22, 2014
Registry last updated
Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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