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Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence (SENSE)

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 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.

Sites / Locations

  • CZ007
  • CZ006
  • CZ005
  • CZ004
  • CZ001
  • EE002
  • EE004
  • EE005
  • EE003
  • EE001
  • HU004
  • HU002
  • LV003
  • LV002
  • LV001
  • LV004
  • LT002
  • LT003
  • PL015
  • PL008
  • PL006
  • PL011
  • PL002
  • PL010
  • PL014
  • PL004
  • PL005
  • PL013
  • PL003
  • PL007
  • PL012
  • PL009
  • PL001
  • RU002
  • RU013
  • RU005
  • RU006
  • RU001
  • RU012
  • RU003
  • RU004
  • SK001
  • SK002
  • SK004
  • SK005
  • UA001
  • UA008
  • UA003
  • UA004
  • UA007
  • UA009
  • UA002
  • UA005
  • UA006
  • UA010
  • GB007
  • GB006
  • GB009
  • GB008
  • GB005

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Nalmefene

Arm Description

Outcomes

Primary Outcome Measures

Number of Patients With Adverse Events (AEs)
Overview of AEs
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
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
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.
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).
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 18, 2008
Last Updated
July 5, 2013
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00811941
Brief Title
Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (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 long-term safety, tolerability and efficacy of nalmefene in patients with 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 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.

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
665 (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, 52 weeks
Intervention Type
Drug
Intervention Name(s)
Nalmefene
Other Intervention Name(s)
Selincro™
Intervention Description
18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
Primary Outcome Measure Information:
Title
Number of Patients With Adverse Events (AEs)
Description
Overview of AEs
Time Frame
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.
Title
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
Time Frame
Baseline to Week 52
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
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 g for men and ≥40 g for women.
Time Frame
Baseline and Month 13
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 13
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 13
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 52
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 52
Title
Liver Function Test Gamma-glutamyl Transferase (GGT)
Description
GGT values
Time Frame
Week 52
Title
Liver Function Test Alanine Aminotransferase (ALAT)
Description
ALAT values
Time Frame
Week 52

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 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.
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
CZ007
City
Litomerice
ZIP/Postal Code
412 01
Country
Czech Republic
Facility Name
CZ006
City
Lnare
ZIP/Postal Code
38742
Country
Czech Republic
Facility Name
CZ005
City
Prague
ZIP/Postal Code
100 00
Country
Czech Republic
Facility Name
CZ004
City
Praha 6
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
CZ001
City
Usti nad Labem
ZIP/Postal Code
400 13
Country
Czech Republic
Facility Name
EE002
City
Parnu
ZIP/Postal Code
80012
Country
Estonia
Facility Name
EE004
City
Tallinn
ZIP/Postal Code
10613
Country
Estonia
Facility Name
EE005
City
Tallinn
ZIP/Postal Code
10613
Country
Estonia
Facility Name
EE003
City
Vorumaa
ZIP/Postal Code
65526
Country
Estonia
Facility Name
EE001
City
Voru
ZIP/Postal Code
65608
Country
Estonia
Facility Name
HU004
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
HU002
City
Budapest
ZIP/Postal Code
1163
Country
Hungary
Facility Name
LV003
City
Daugavpils
ZIP/Postal Code
5403
Country
Latvia
Facility Name
LV002
City
Jelgava
ZIP/Postal Code
3008
Country
Latvia
Facility Name
LV001
City
Riga
ZIP/Postal Code
1013
Country
Latvia
Facility Name
LV004
City
Sigulda
ZIP/Postal Code
2150
Country
Latvia
Facility Name
LT002
City
Kaunas
ZIP/Postal Code
44184
Country
Lithuania
Facility Name
LT003
City
Kaunas
ZIP/Postal Code
50185
Country
Lithuania
Facility Name
PL015
City
Belchatow
ZIP/Postal Code
97-400
Country
Poland
Facility Name
PL008
City
Bydgoszcz
ZIP/Postal Code
85-096
Country
Poland
Facility Name
PL006
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
PL011
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
Facility Name
PL002
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
Facility Name
PL010
City
Lodz
ZIP/Postal Code
91-229
Country
Poland
Facility Name
PL014
City
Lodz
ZIP/Postal Code
91-229
Country
Poland
Facility Name
PL004
City
Lublin
ZIP/Postal Code
20-015
Country
Poland
Facility Name
PL005
City
Lublin
ZIP/Postal Code
20-109
Country
Poland
Facility Name
PL013
City
Piekary Slaskie
ZIP/Postal Code
41-940
Country
Poland
Facility Name
PL003
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
PL007
City
Starogard Gdanski
ZIP/Postal Code
83-200
Country
Poland
Facility Name
PL012
City
Swicie n/Wisla
ZIP/Postal Code
86-100
Country
Poland
Facility Name
PL009
City
Szczecin
ZIP/Postal Code
71-460
Country
Poland
Facility Name
PL001
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
RU002
City
Leningrad
ZIP/Postal Code
18861
Country
Russian Federation
Facility Name
RU013
City
Rostov on Don
ZIP/Postal Code
344010
Country
Russian Federation
Facility Name
RU005
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
RU006
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
RU001
City
St. Petersburg
ZIP/Postal Code
193015
Country
Russian Federation
Facility Name
RU012
City
St. Petersburg
ZIP/Postal Code
194022
Country
Russian Federation
Facility Name
RU003
City
St. Petersburg
ZIP/Postal Code
197198
Country
Russian Federation
Facility Name
RU004
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
SK001
City
Banska Bysterica
ZIP/Postal Code
974 01
Country
Slovakia
Facility Name
SK002
City
Krupina
ZIP/Postal Code
963 01
Country
Slovakia
Facility Name
SK004
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
SK005
City
Rimavska Sobota
ZIP/Postal Code
97912
Country
Slovakia
Facility Name
UA001
City
Chernihiv
ZIP/Postal Code
14000
Country
Ukraine
Facility Name
UA008
City
Dnipropetrovsk
ZIP/Postal Code
49616
Country
Ukraine
Facility Name
UA003
City
Donetsk
ZIP/Postal Code
83037
Country
Ukraine
Facility Name
UA004
City
Glevakha
ZIP/Postal Code
8630
Country
Ukraine
Facility Name
UA007
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
UA009
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
UA002
City
Kyiv
ZIP/Postal Code
4080
Country
Ukraine
Facility Name
UA005
City
Odessa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
UA006
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
UA010
City
Ternopil
ZIP/Postal Code
46020
Country
Ukraine
Facility Name
GB007
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
GB006
City
Glasgow
Country
United Kingdom
Facility Name
GB009
City
London
Country
United Kingdom
Facility Name
GB008
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
GB005
City
Reading
ZIP/Postal Code
RG2 0TG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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

Learn more about this trial

Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

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