Efficacy of Nalmefene in Patients With Alcohol Dependence

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00812461
• Date of registration: 19/12/2008
• Prospective Registration: Yes
• Primary sponsor: H. Lundbeck A/S
• Public title: Efficacy of Nalmefene in Patients With Alcohol Dependence ESENSE2
• Scientific title: Nalmefene Efficacy Study II: Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy Study of 20 mg Nalmefene, as Needed Use, in Patients With Alcohol Dependence
• Date of first enrolment: March 2009
• Target sample size: 678
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00812461
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Belgium, Czech Republic, France, Italy, Poland, Portugal, Spain

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Other protocol-defined inclusion and exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Alcohol Dependence

Intervention(s)

Drug: Nalmefene

Drug: Placebo

Primary Outcome(s)

Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) [Time Frame: Baseline and Month 6]

Change From Baseline in the Monthly Total Alcohol Consumption (TAC) [Time Frame: Baseline and Month 6]

Secondary Outcome(s)

Liver Function Test Alanine Aminotransferase (ALAT) [Time Frame: Week 24]

Liver Function Test Gamma-glutamyl Transferase (GGT) [Time Frame: Week 24]

Change in Clinical Status Using the CGI-I [Time Frame: Week 24]

Drinking Risk Level (RSDRL) Response [Time Frame: Month 6]

Change From Baseline in Clinical Status Using CGI-S [Time Frame: Baseline and Week 24]

Secondary ID(s)

12023A

2007-002563-27

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/07/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00812461