Efficacy of Nalmefene in Patients With Alcohol Dependence

NCT00812461 | Completed Phase 3 Results

• 2 other identifiers: 12023A2007-002563-27
• Study Type: interventional
• Target: 678
• Locations: 7 countries
• Sites: 57

Brief Summary

The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.

Conditions

Alcohol Dependence

Keywords

Pharmacologic Actions; Alcohol-Related Disorders; Alcoholism; Mental Disorders; Central Nervous System Agents

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)

  Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.

  Baseline and Month 6

• Change From Baseline in the Monthly Total Alcohol Consumption (TAC)

  TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).

  Baseline and Month 6

Secondary Outcomes (5)

• Drinking Risk Level (RSDRL) Response

  Month 6

• Change From Baseline in Clinical Status Using CGI-S

  Baseline and Week 24

• Change in Clinical Status Using the CGI-I

  Week 24

• Liver Function Test Gamma-glutamyl Transferase (GGT)

  Week 24

• Liver Function Test Alanine Aminotransferase (ALAT)

  Week 24

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Nalmefene

EXPERIMENTAL

Drug: Nalmefene

Interventions

Placebo DRUG

as-needed use, tablets, orally, 6 months

Placebo

Nalmefene DRUG

18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Also known as: Selincro™

Nalmefene

Eligibility Criteria

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

You may qualify if:

• In- and outpatients who:
• had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - text revision (DSM-IV-TR) criteria
• had had ≥6 HDDs in the 4 weeks preceding the Screening Visit
• had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit

You may not qualify if:

• The patient:
• had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence
• had an antisocial personality disorder
• had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)
• had a history of delirium tremens or alcohol withdrawal seizures
• reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists
• reported current or recent treatment with antipsychotics or antidepressants
• was pregnant or breast-feeding

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (57)

BE002

Assebroek, 8310, Belgium

Location

BE007

Bruges, 8000, Belgium

Location

BE006

Charleroi, 6000, Belgium

Location

BE005

Kortenberg, 3070, Belgium

Location

BE001

Liège, 4000, Belgium

Location

BE003

Mechelen, 2800, Belgium

Location

BE004

Ostend, 8400, Belgium

Location

CZ001

Litoměřice, 41201, Czechia

Location

CZ002

Prague, 100 00, Czechia

Location

CZ003

Prague, 160 00, Czechia

Location

FR008

Angers, 4933, France

Location

FR004

Bully-les-Mines, 62160, France

Location

FR009

Clichy, 92110, France

Location

FR012

Élancourt, 78990, France

Location

FR021

La Rochelle, 17022, France

Location

FR011

Le Pecq, 78230, France

Location

FR019

Lille, 59037, France

Location

FR016

Lyon, 69005, France

Location

FR014

Nancy, 54000, France

Location

FR015

Nîmes, 30029, France

Location

FR002

Rennes, 35000, France

Location

FR001

Sartrouville, 78500, France

Location

FR007

Strasbourg, 67000, France

Location

FR005

Toulouse, 31000, France

Location

FR006

Toulouse, 31200, France

Location

FR003

Villejuif, 94804, France

Location

IT017

Bologna, 40123, Italy

Location

IT013

Bologna, 44042, Italy

Location

IT008

Cento, 44042, Italy

Location

IT006

Florence, 50134, Italy

Location

IT002

Parma, 43100, Italy

Location

IT007

Rome, 00123, Italy

Location

IT001

Rome, 00163, Italy

Location

IT011

Rome, RM 00168, Italy

Location

IT004

Rome, RM 00186, Italy

Location

IT018

Soverato Marina, CZ 88068, Italy

Location

PL005

Gdansk, 80-952, Poland

Location

PL004

Leszno, 64-100, Poland

Location

PL006

Lublin, 20-109, Poland

Location

PL007

Lublin, 20-442, Poland

Location

PL002

Piekary Śląskie, 41940, Poland

Location

PL003

Skorzewo, 60-185, Poland

Location

PL001

Szczecin, 71-460, Poland

Location

PT003

Angra do Heroísmo, 9700-161, Portugal

Location

PT002

Lisbon, 1350-179, Portugal

Location

PT001

Lisbon, 1649-035, Portugal

Location

PT006

Mem Martins, 2725, Portugal

Location

ES005

Alicante, 3550, Spain

Location

ES006

Barcelona, 8003, Spain

Location

ES008

Barcelona, 8025, Spain

Location

ES004

Barcelona, 8028, Spain

Location

ES014

Burgos, 9006, Spain

Location

ES010

Madrid, 28034, Spain

Location

ES001

Mallorca, 7193, Spain

Location

ES002

Oviedo, 33011, Spain

Location

ES003

Valencia, 46010, Spain

Location

ES011

Zamora, 49021, Spain

Location

Related Publications (4)

• Gual A, He Y, Torup L, van den Brink W, Mann K; ESENSE 2 Study Group. A randomised, double-blind, placebo-controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence. Eur Neuropsychopharmacol. 2013 Nov;23(11):1432-42. doi: 10.1016/j.euroneuro.2013.02.006. Epub 2013 Apr 3.

  PMID: 23562264 RESULT

• Aubin HJ, Reimer J, Nutt DJ, Bladstrom A, Torup L, Francois C, Chick J. Clinical relevance of as-needed treatment with nalmefene in alcohol-dependent patients. Eur Addict Res. 2015;21(3):160-168. doi: 10.1159/000371547. Epub 2015 Mar 31.

  PMID: 25832297 DERIVED

• Laramee P, Brodtkorb TH, Rahhali N, Knight C, Barbosa C, Francois C, Toumi M, Daeppen JB, Rehm J. The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model. BMJ Open. 2014 Sep 16;4(9):e005376. doi: 10.1136/bmjopen-2014-005376.

  PMID: 25227627 DERIVED

• van den Brink W, Aubin HJ, Bladstrom A, Torup L, Gual A, Mann K. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013 Sep-Oct;48(5):570-8. doi: 10.1093/alcalc/agt061. Epub 2013 Jul 19.

  PMID: 23873853 DERIVED

MeSH Terms

Conditions

Alcoholism; Alcohol-Related Disorders; Mental Disorders

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: H. Lundbeck A/S
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

+45 3630 1311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: March 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 22, 2013
• Results First Posted: July 9, 2013

Record last verified: 2013-07

Locations

FR (16); CZ (3); PT (4); ES (10); PL (7); BE (7); IT (10)