Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

NCT00811941 | Completed Phase 3 Results

• 2 other identifiers: 12013A2007-002315-92
• Study Type: interventional
• Target: 665
• Locations: 10 countries
• Sites: 60

Brief Summary

The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with alcohol dependence.

Conditions

Alcohol Dependence

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Number of Patients With Adverse Events (AEs)

  Overview of AEs

  Serious Adverse Events: 52 weeks and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 52 weeks.

• Percentage of Patients Who Withdrew Due to Intolerance to Treatment

  Baseline to Week 52

• 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 (12)

• 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, 52 weeks

Placebo

Nalmefene DRUG

18.06 mg as-needed use, tablets, orally, 52 weeks. 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 Heavy Drinking Days (HDDs) in the 4 weeks preceding the Screening Visit

You may not qualify if:

• The patient:
• had a severe psychiatric disorder or 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
• was pregnant or breast-feeding

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (60)

CZ007

Litoměřice, 412 01, Czechia

Location

CZ006

Lnáře, 38742, Czechia

Location

CZ005

Prague, 100 00, Czechia

Location

CZ004

Prague, 160 00, Czechia

Location

CZ001

Ústí nad Labem, 400 13, Czechia

Location

EE002

Pärnu, 80012, Estonia

Location

EE004

Tallinn, 10613, Estonia

Location

EE005

Tallinn, 10613, Estonia

Location

EE003

Vorumaa, 65526, Estonia

Location

EE001

Võru, 65608, Estonia

Location

HU004

Budapest, 1135, Hungary

Location

HU002

Budapest, 1163, Hungary

Location

LV003

Daugavpils, 5403, Latvia

Location

LV002

Jelgava, 3008, Latvia

Location

LV001

Riga, 1013, Latvia

Location

LV004

Sigulda, 2150, Latvia

Location

LT002

Kaunas, 44184, Lithuania

Location

LT003

Kaunas, 50185, Lithuania

Location

PL015

Bełchatów, 97-400, Poland

Location

PL008

Bydgoszcz, 85-096, Poland

Location

PL006

Gdansk, 80-211, Poland

Location

PL011

Krakow, 31-826, Poland

Location

PL002

Leszno, 64-100, Poland

Location

PL010

Lodz, 91-229, Poland

Location

PL014

Lodz, 91-229, Poland

Location

PL004

Lublin, 20-015, Poland

Location

PL005

Lublin, 20-109, Poland

Location

PL013

Piekary Śląskie, 41-940, Poland

Location

PL003

Skorzewo, 60-185, Poland

Location

PL007

Starogard Gdański, 83-200, Poland

Location

PL012

Swicie n/Wisla, 86-100, Poland

Location

PL009

Szczecin, 71-460, Poland

Location

PL001

Torun, 87-100, Poland

Location

RU013

Rostov-on-Don, 344010, Russia

Location

RU002

Saint Petersburg, 18861, Russia

Location

RU005

Saint Petersburg, 192019, Russia

Location

RU006

Saint Petersburg, 192019, Russia

Location

RU001

Saint Petersburg, 193015, Russia

Location

RU012

Saint Petersburg, 194022, Russia

Location

RU003

Saint Petersburg, 197198, Russia

Location

RU004

Voronezh, 394000, Russia

Location

SK001

Banska Bysterica, 974 01, Slovakia

Location

SK002

Krupina, 963 01, Slovakia

Location

SK004

Nitra, 949 01, Slovakia

Location

SK005

Rimavská Sobota, 97912, Slovakia

Location

UA001

Chernihiv, 14000, Ukraine

Location

UA008

Dnipropetrovsk, 49616, Ukraine

Location

UA003

Donetsk, 83037, Ukraine

Location

UA004

Hlevakha, 8630, Ukraine

Location

UA007

Kharkiv, 61068, Ukraine

Location

UA009

Kherson, 73488, Ukraine

Location

UA002

Kyiv, 4080, Ukraine

Location

UA005

Odesa, 65006, Ukraine

Location

UA006

Simferopol, 95006, Ukraine

Location

UA010

Ternopil, 46020, Ukraine

Location

GB007

Birmingham, B15 2SQ, United Kingdom

Location

GB006

Glasgow, United Kingdom

Location

GB009

London, United Kingdom

Location

GB008

Manchester, M15 6SX, United Kingdom

Location

GB005

Reading, RG2 0TG, United Kingdom

Location

Related Publications (1)

• 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

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 18, 2008
• First Posted: December 19, 2008
• Study Start: March 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 7, 2013
• Results First Posted: August 7, 2013

Record last verified: 2013-07

Locations

UA (10); PL (15); RU (8); HU (2); CZ (5); ES (5); SL (4); LA (4); LI (2); GB (5)