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

July 5, 2013 updated by: H. Lundbeck A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

665

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
as-needed use, tablets, orally, 52 weeks
Experimental: Nalmefene
Drug: Nalmefene
18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
Other Names:
  • Selincro™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
Time Frame: Baseline to Week 52
Baseline to Week 52
Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)
Time Frame: Baseline and Month 6
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
Change From Baseline in the Monthly Total Alcohol Consumption (TAC)
Time Frame: Baseline and Month 6
TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
Baseline and Month 6
Number of Patients With Adverse Events (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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinking Risk Level (RSDRL) Response
Time Frame: Month 6
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
Change From Baseline in Clinical Status Using CGI-S
Time Frame: Baseline and Week 24
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
Liver Function Test Gamma-glutamyl Transferase (GGT)
Time Frame: Week 24
GGT values
Week 24
Liver Function Test Alanine Aminotransferase (ALAT)
Time Frame: Week 24
ALAT values
Week 24
Change in Clinical Status Using the CGI-I
Time Frame: Week 24
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
Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)
Time Frame: Baseline and Month 13
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
Change From Baseline in the Monthly Total Alcohol Consumption (TAC)
Time Frame: Baseline and Month 13
TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
Baseline and Month 13
Drinking Risk Level (RSDRL) Response
Time Frame: Month 13
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
Change From Baseline in Clinical Status Using CGI-S
Time Frame: Baseline and Week 52
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
Change in Clinical Status Using the CGI-I
Time Frame: Week 52
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
Liver Function Test Gamma-glutamyl Transferase (GGT)
Time Frame: Week 52
GGT values
Week 52
Liver Function Test Alanine Aminotransferase (ALAT)
Time Frame: Week 52
ALAT values
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 18, 2008

First Posted (Estimate)

December 19, 2008

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

July 5, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12013A
  • 2007-002315-92 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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