Phase 3 N=675 Randomized Double-blind Treatment

Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

Alcohol Dependence

Bottom Line

View on ClinicalTrials.gov: NCT00811941 ↗

Enrolled (actual)

675

Serious AEs

6.5%

Results posted

Aug 2013

Primary outcome: Primary: Number of Patients With Adverse Events (AEs) — 103; 377; 8; 35 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Nalmefene (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: H. Lundbeck A/S
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Adverse Events (AEs)	103; 377; 8; 35; 5; 57	—
PRIMARY Percentage of Patients Who Withdrew Due to Intolerance to Treatment	1.2; 8.6	—
PRIMARY Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)	-8.96; -10.53	0.017 sig
PRIMARY Change From Baseline in the Monthly Total Alcohol Consumption (TAC)	-46.33; -52.80	0.036 sig
SECONDARY Drinking Risk Level (RSDRL) Response	54.0; 54.5	0.976
SECONDARY Change From Baseline in Clinical Status Using CGI-S	-1.08; -1.30	0.056
SECONDARY Change in Clinical Status Using the CGI-I	2.52; 2.26	0.029 sig
SECONDARY Liver Function Test Gamma-glutamyl Transferase (GGT)	41.3; 32.0	0.001 sig
SECONDARY Liver Function Test Alanine Aminotransferase (ALAT)	27.8; 24.6	0.037 sig
SECONDARY Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)	-8.96; -10.53	0.017 sig
SECONDARY Change From Baseline in the Monthly Total Alcohol Consumption (TAC)	-46.33; -52.80	0.036 sig
SECONDARY Drinking Risk Level (RSDRL) Response	54.0; 54.5	0.976
SECONDARY Change From Baseline in Clinical Status Using CGI-S	-1.08; -1.30	0.056
SECONDARY Change in Clinical Status Using the CGI-I	2.52; 2.26	0.029 sig
SECONDARY Liver Function Test Gamma-glutamyl Transferase (GGT)	41.3; 32.0	0.001 sig
SECONDARY Liver Function Test Alanine Aminotransferase (ALAT)	27.8; 24.6	0.037 sig

Summary

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

Eligibility 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 Heavy Drinking Days (HDDs) in the 4 weeks preceding the Screening Visit

Exclusion Criteria

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

Other protocol-defined inclusion and exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00811941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.