Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.

NCT02824354 | Withdrawn Phase 3

• 1 other identifier: PI2015_843_0017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption.

Conditions

Cirrhosis; Alcohol Dependence; Nalmefene

Outcome Measures

Primary Outcomes (1)

• Reduction of the number of monthly heavy drinking days after 6 months of treatment compared to baseline.

  6 months

Secondary Outcomes (4)

• The number of non-drinking days during the treatment period; nalmefene arm versus placebo arm,

  6 months

• Evaluation of craving; nalmefene arm responders versus nalmefene arm non-responders

  6 months

• Course of liver function after 6 months of treatment compared to baseline

  6 months

• 6 months survival

  6 months

Study Arms (2)

placebo

PLACEBO COMPARATOR

The placebo will have the same composition as the active treatment (without the drug substance) and an identical appearance. White, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with "S" on one side.

Drug: placebo

Nalmefene

EXPERIMENTAL

Drug : 'Nalmefene (Selincro®) 18 mg tablet is a white, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with "S" on one side. It contains 18.06 mg nalmefene (in the form of hydrochloride dihydrate). Nalmefene must be taken as-needed: on each day the patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking. If the patient has started drinking alcohol without taking nalmefene, the patient should take one tablet as soon as possible. The maximum dose of nalmefene is one tablet per day. Nalmefene can be taken with or without food.

Drug: Nalmefene (Selincro®) 18 mg tablet

Interventions

Nalmefene (Selincro®) 18 mg tablet DRUG

Evaluate the efficacy, tolerability and safety of nalmefene for reduction of alcohol consumption (reduction of the number of monthly heavy drinking days, and daily total alcohol consumption) in alcohol-dependent patients with alcoholic compensated cirrhosis.

Nalmefene

placebo DRUG

Evaluate the efficacy, tolerability and safety of nalmefene for reduction of alcohol consumption (reduction of the number of monthly heavy drinking days, and daily total alcohol consumption) in alcohol-dependent patients with alcoholic compensated cirrhosis.

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the patient has signed and dated the informed consent form,
• blood alcohol concentration \< 0.02% at the screening visit,
• alcohol-dependent patient according to DSM-IV-TR criteria ,
• patient with compensated cirrhosis (cirrhosis demonstrated by clinical and laboratory and/or morphological examinations and/or by a noninvasive test and/or by liver biopsy), Child A or B,
• patient with at least a high drinking risk level (a moderate risk level is defined as a consumption ≥ 60 g of alcohol/day for men and ≥ 40 g of alcohol/day for women),
• male or female, over the age of 18 years, excluding protected majors,
• patient with a stable address and telephone number,
• name and address of a family member who will be contacted in the event of loss of contact with the patient,
• women of childbearing potential:
• must accept not to become pregnant during the study and,
• must use an effective method of contraception (adequate contraception is defined as oral, systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for the male partner in combination with spermicide) or,
• must have had their last natural menstruation ≥ 24 months before the screening visit or,
• must have been surgically sterilized before the screening visit or,
• must have undergone hysterectomy before the screening visit or,
• must have no sexual activity with a male partner

You may not qualify if:

• cirrhosis Child Pugh C (decompensated cirrhosis)
• cirrhosis complicated by hepatocellular carcinoma or type I or II hepatorenal syndrome or poorly controlled portal hypertension,
• severe acute alcoholic hepatitis, not responding to corticosteroids by the 7th day defined by a Lille model \> 0.56 (www.lillemodel.com/score.asp)
• hepatic encephalopathy during the 6 months preceding the screening visit,
• patient with fewer than 6 heavy drinking days during the 4 weeks preceding the screening visit (a heavy drinking day is defined as alcohol consumption of ≥ 60 g/day for men, and ≥ 40 g/day for women),
• patient with at least 14 consecutive days of abstinence during the 4 weeks preceding the screening visit,
• patient with a CIWA-Ar score (Revised Clinical Institute Withdrawal Assessment for Alcohol) ≥ 10,
• patient with:
• a disorder other than alcohol or nicotine dependence, as evaluated on the MINI (Mini-International Neuropsychiatric Interview)
• antisocial personality disorder evaluated with the MINI questionnaire,
• other disorders for which treatment must take priority to the treatment of alcohol dependence, or which are likely to interfere with the study treatment or compromise adherence to treatment,
• patient with a suicide risk evaluated using the suicidal tendency module of the MINI (the patient answers "Yes" to one of questions C2, C3, C4, C5 or C6 of the questionnaire),
• patient with a history of delirium tremens or alcohol withdrawal seizures,
• ongoing use of addictive substances other than cannabis, nicotine or benzodiazepines,
• presence of a disorder of comprehension, mental retardation or encephalopathy,

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Fibrosis; Alcoholism

Interventions

nalmefene; Tablets

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Eric NGUYEN-KHAC, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 6, 2016
• Study Start: December 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

FR (1)