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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02197598
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: nalmefene Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory, Interventional, Open-label, Fixed-dose Study With Selincro® As-needed Use, in Alcohol Dependent Patients With Liver Impairment
Study Start Date : September 2014
Actual Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: nalmefene
Other Name: Selincro®




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Other protocol-defined inclusion and exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197598


Locations
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Germany
DE001
Heidelberg, Germany
DE002
Mannheim, Germany
Optuminisight
München, Germany
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H.Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
Study Data/Documents: EMA EudraCT Results  This link exits the ClinicalTrials.gov site
Identifier: 2014-000413-31

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02197598    
Other Study ID Numbers: 15871A
2014-000413-31 ( EudraCT Number )
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Keywords provided by H. Lundbeck A/S:
nalmefene, alcohol consumption, liver effects
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nalmefene
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents