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Efficacy of Nalmefene in Patients With Alcohol Dependence (ESENSE2)

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Nalmefene
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Pharmacologic Actions, Alcohol-Related Disorders, Alcoholism, Mental Disorders, Central Nervous System Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • BE002
  • BE007
  • BE006
  • BE005
  • BE001
  • BE003
  • BE004
  • CZ001
  • CZ002
  • CZ003
  • FR008
  • FR004
  • FR009
  • FR012
  • FR021
  • FR011
  • FR019
  • FR016
  • FR014
  • FR015
  • FR002
  • FR001
  • FR007
  • FR005
  • FR006
  • FR003
  • IT017
  • IT013
  • IT008
  • IT006
  • IT002
  • IT007
  • IT001
  • IT011
  • IT004
  • IT018
  • PL005
  • PL004
  • PL006
  • PL007
  • PL002
  • PL003
  • PL001
  • PT003
  • PT002
  • PT001
  • PT006
  • ES005
  • ES006
  • ES008
  • ES004
  • ES014
  • ES010
  • ES001
  • ES002
  • ES003
  • ES011

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Nalmefene

Arm Description

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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).
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).
Liver Function Test Gamma-glutamyl Transferase (GGT)
GGT values
Liver Function Test Alanine Aminotransferase (ALAT)
ALAT values

Full Information

First Posted
December 19, 2008
Last Updated
July 17, 2013
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00812461
Brief Title
Efficacy of Nalmefene in Patients With Alcohol Dependence
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Pharmacologic Actions, Alcohol-Related Disorders, Alcoholism, Mental Disorders, Central Nervous System Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
678 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Nalmefene
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
as-needed use, tablets, orally, 6 months
Intervention Type
Drug
Intervention Name(s)
Nalmefene
Other Intervention Name(s)
Selincro™
Intervention Description
18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
Primary Outcome Measure Information:
Title
Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)
Description
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.
Time Frame
Baseline and Month 6
Title
Change From Baseline in the Monthly Total Alcohol Consumption (TAC)
Description
TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
Time Frame
Baseline and Month 6
Secondary Outcome Measure Information:
Title
Drinking Risk Level (RSDRL) Response
Description
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.
Time Frame
Month 6
Title
Change From Baseline in Clinical Status Using CGI-S
Description
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).
Time Frame
Baseline and Week 24
Title
Change in Clinical Status Using the CGI-I
Description
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).
Time Frame
Week 24
Title
Liver Function Test Gamma-glutamyl Transferase (GGT)
Description
GGT values
Time Frame
Week 24
Title
Liver Function Test Alanine Aminotransferase (ALAT)
Description
ALAT values
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
BE002
City
Assebroek
ZIP/Postal Code
8310
Country
Belgium
Facility Name
BE007
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
BE006
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
BE005
City
Kortenberg
ZIP/Postal Code
3070
Country
Belgium
Facility Name
BE001
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
BE003
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
BE004
City
Oostende
ZIP/Postal Code
8400
Country
Belgium
Facility Name
CZ001
City
Litomerice
ZIP/Postal Code
41201
Country
Czech Republic
Facility Name
CZ002
City
Praha 10
ZIP/Postal Code
100 00
Country
Czech Republic
Facility Name
CZ003
City
Praha 6
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
FR008
City
Angers
ZIP/Postal Code
4933
Country
France
Facility Name
FR004
City
Bully les Mines
ZIP/Postal Code
62160
Country
France
Facility Name
FR009
City
Clichy Cedex 92
ZIP/Postal Code
92110
Country
France
Facility Name
FR012
City
Elancourt
ZIP/Postal Code
78990
Country
France
Facility Name
FR021
City
La Rochelle
ZIP/Postal Code
17022
Country
France
Facility Name
FR011
City
Le Pecq
ZIP/Postal Code
78230
Country
France
Facility Name
FR019
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
FR016
City
Lyon
ZIP/Postal Code
69005
Country
France
Facility Name
FR014
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
FR015
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
FR002
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
FR001
City
Sartrouville
ZIP/Postal Code
78500
Country
France
Facility Name
FR007
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
FR005
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
FR006
City
Toulouse
ZIP/Postal Code
31200
Country
France
Facility Name
FR003
City
Villejuif
ZIP/Postal Code
94804
Country
France
Facility Name
IT017
City
Bologna
ZIP/Postal Code
40123
Country
Italy
Facility Name
IT013
City
Bologna
ZIP/Postal Code
44042
Country
Italy
Facility Name
IT008
City
Cento
ZIP/Postal Code
44042
Country
Italy
Facility Name
IT006
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
IT002
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
IT007
City
Rome
ZIP/Postal Code
00123
Country
Italy
Facility Name
IT001
City
Rome
ZIP/Postal Code
00163
Country
Italy
Facility Name
IT011
City
Rome
ZIP/Postal Code
RM 00168
Country
Italy
Facility Name
IT004
City
Rome
ZIP/Postal Code
RM 00186
Country
Italy
Facility Name
IT018
City
Soverato
ZIP/Postal Code
CZ 88068
Country
Italy
Facility Name
PL005
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
PL004
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
Facility Name
PL006
City
Lublin
ZIP/Postal Code
20-109
Country
Poland
Facility Name
PL007
City
Lublin
ZIP/Postal Code
20-442
Country
Poland
Facility Name
PL002
City
Piekary Slaskie
ZIP/Postal Code
41940
Country
Poland
Facility Name
PL003
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
PL001
City
Szczecin
ZIP/Postal Code
71-460
Country
Poland
Facility Name
PT003
City
Angra do Heroismo
ZIP/Postal Code
9700-161
Country
Portugal
Facility Name
PT002
City
Lisboa
ZIP/Postal Code
1350-179
Country
Portugal
Facility Name
PT001
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
PT006
City
Mem Martins
ZIP/Postal Code
2725
Country
Portugal
Facility Name
ES005
City
Alicante
ZIP/Postal Code
3550
Country
Spain
Facility Name
ES006
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
ES008
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Facility Name
ES004
City
Barcelona
ZIP/Postal Code
8028
Country
Spain
Facility Name
ES014
City
Burgos
ZIP/Postal Code
9006
Country
Spain
Facility Name
ES010
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
ES001
City
Mallorca
ZIP/Postal Code
7193
Country
Spain
Facility Name
ES002
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
ES003
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
ES011
City
Zamora
ZIP/Postal Code
49021
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23562264
Citation
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: 10.1016/j.euroneuro.2013.02.006. Epub 2013 Apr 3.
Results Reference
result
PubMed Identifier
25832297
Citation
Aubin HJ, Reimer J, Nutt DJ, Bladstrom A, Torup L, Francois C, Chick J. Clinical relevance of as-needed treatment with nalmefene in alcohol-dependent patients. Eur Addict Res. 2015;21(3):160-168. doi: 10.1159/000371547. Epub 2015 Mar 31.
Results Reference
derived
PubMed Identifier
25227627
Citation
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.
Results Reference
derived
PubMed Identifier
23873853
Citation
van den Brink W, Aubin HJ, Bladstrom A, Torup L, Gual A, Mann K. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013 Sep-Oct;48(5):570-8. doi: 10.1093/alcalc/agt061. Epub 2013 Jul 19. Erratum In: Alcohol Alcohol. 2013 Nov-Dec;48(6):746.
Results Reference
derived

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Efficacy of Nalmefene in Patients With Alcohol Dependence

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