Efficacy of Nalmefene in Patients With Alcohol Dependence

Alcohol Dependence Clinical Trial

— ESENSE2  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812461
• Other study ID #: 12023A
• Secondary ID: 2007-002563-27
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2008
• Last updated: July 17, 2013
• Start date: March 2009
• Est. completion date: April 2011

Study information

• Verified date: July 2013
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: The Italian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Description:

Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the efficacy and safety of as needed use of nalmefene 18.06 mg versus placebo in decreasing monthly Heavy Drinking Days (HDDs) and decreasing the total consumption during a period of 24 weeks in adult patients with alcohol dependence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 678
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Placebo
as-needed use, tablets, orally, 6 months
• Nalmefene
18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Locations

Country	Name	City	State
Belgium	BE002	Assebroek
Belgium	BE007	Brugge
Belgium	BE006	Charleroi
Belgium	BE005	Kortenberg
Belgium	BE001	Liège
Belgium	BE003	Mechelen
Belgium	BE004	Oostende
Czech Republic	CZ001	Litomerice
Czech Republic	CZ002	Praha 10
Czech Republic	CZ003	Praha 6
France	FR008	Angers
France	FR004	Bully les Mines
France	FR009	Clichy Cedex 92
France	FR012	Elancourt
France	FR021	La Rochelle
France	FR011	Le Pecq
France	FR019	Lille
France	FR016	Lyon
France	FR014	Nancy
France	FR015	Nimes
France	FR002	Rennes
France	FR001	Sartrouville
France	FR007	Strasbourg
France	FR005	Toulouse
France	FR006	Toulouse
France	FR003	Villejuif
Italy	IT013	Bologna
Italy	IT017	Bologna
Italy	IT008	Cento
Italy	IT006	Firenze
Italy	IT002	Parma
Italy	IT001	Rome
Italy	IT004	Rome
Italy	IT007	Rome
Italy	IT011	Rome
Italy	IT018	Soverato
Poland	PL005	Gdansk
Poland	PL004	Leszno
Poland	PL006	Lublin
Poland	PL007	Lublin
Poland	PL002	Piekary Slaskie
Poland	PL003	Skorzewo
Poland	PL001	Szczecin
Portugal	PT003	Angra do Heroismo
Portugal	PT001	Lisboa
Portugal	PT002	Lisboa
Portugal	PT006	Mem Martins
Spain	ES005	Alicante
Spain	ES004	Barcelona
Spain	ES006	Barcelona
Spain	ES008	Barcelona
Spain	ES014	Burgos
Spain	ES010	Madrid
Spain	ES001	Mallorca
Spain	ES002	Oviedo
Spain	ES003	Valencia
Spain	ES011	Zamora

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

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

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Drinking Risk Level (RSDRL) Response	RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.	Month 6	No
Secondary	Change From Baseline in Clinical Status Using CGI-S	The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).	Baseline and Week 24	No
Secondary	Change in Clinical Status Using the CGI-I	The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).	Week 24	No
Secondary	Liver Function Test Gamma-glutamyl Transferase (GGT)	GGT values	Week 24	No
Secondary	Liver Function Test Alanine Aminotransferase (ALAT)	ALAT values	Week 24	No