Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

Alcohol Dependence Clinical Trial

— SENSE  

Official title:

A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Safety, Tolerability and Efficacy Study of Nalmefene, as Needed Use, in Patients With Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811941
• Other study ID #: 12013A
• Secondary ID: 2007-002315-92
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2008
• Last updated: July 5, 2013
• Start date: March 2009
• Est. completion date: November 2010

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 ControlEstonia: The State Agency of MedicineHungary: National Institute of PharmacyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlUkraine: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with 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 long-term safety and tolerability as well as to evaluate the efficacy of as needed use of 18.06 mg nalmefene in patients with alcohol dependence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 665
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• 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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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, 52 weeks
• Nalmefene
18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Locations

Country	Name	City	State
Czech Republic	CZ007	Litomerice
Czech Republic	CZ006	Lnare
Czech Republic	CZ005	Prague
Czech Republic	CZ004	Praha 6
Czech Republic	CZ001	Usti nad Labem
Estonia	EE002	Parnu
Estonia	EE004	Tallinn
Estonia	EE005	Tallinn
Estonia	EE001	Voru
Estonia	EE003	Vorumaa
Hungary	HU002	Budapest
Hungary	HU004	Budapest
Latvia	LV003	Daugavpils
Latvia	LV002	Jelgava
Latvia	LV001	Riga
Latvia	LV004	Sigulda
Lithuania	LT002	Kaunas
Lithuania	LT003	Kaunas
Poland	PL015	Belchatow
Poland	PL008	Bydgoszcz
Poland	PL006	Gdansk
Poland	PL011	Krakow
Poland	PL002	Leszno
Poland	PL010	Lodz
Poland	PL014	Lodz
Poland	PL004	Lublin
Poland	PL005	Lublin
Poland	PL013	Piekary Slaskie
Poland	PL003	Skorzewo
Poland	PL007	Starogard Gdanski
Poland	PL012	Swicie n/Wisla
Poland	PL009	Szczecin
Poland	PL001	Torun
Russian Federation	RU002	Leningrad
Russian Federation	RU013	Rostov on Don
Russian Federation	RU001	St. Petersburg
Russian Federation	RU003	St. Petersburg
Russian Federation	RU005	St. Petersburg
Russian Federation	RU006	St. Petersburg
Russian Federation	RU012	St. Petersburg
Russian Federation	RU004	Voronezh
Slovakia	SK001	Banska Bysterica
Slovakia	SK002	Krupina
Slovakia	SK004	Nitra
Slovakia	SK005	Rimavska Sobota
Ukraine	UA001	Chernihiv
Ukraine	UA008	Dnipropetrovsk
Ukraine	UA003	Donetsk
Ukraine	UA004	Glevakha
Ukraine	UA007	Kharkiv
Ukraine	UA009	Kherson
Ukraine	UA002	Kyiv
Ukraine	UA005	Odessa
Ukraine	UA006	Simferopol
Ukraine	UA010	Ternopil
United Kingdom	GB007	Birmingham
United Kingdom	GB006	Glasgow
United Kingdom	GB009	London
United Kingdom	GB008	Manchester
United Kingdom	GB005	Reading

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Czech Republic,  Estonia,  Hungary,  Latvia,  Lithuania,  Poland,  Russian Federation,  Slovakia,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	Percentage of Patients Who Withdrew Due to Intolerance to Treatment		Baseline to Week 52	Yes
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
Secondary	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 g for men and =40 g for women.	Baseline and Month 13	No
Secondary	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 13	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 13	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 52	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 52	No
Secondary	Liver Function Test Gamma-glutamyl Transferase (GGT)	GGT values	Week 52	No
Secondary	Liver Function Test Alanine Aminotransferase (ALAT)	ALAT values	Week 52	No