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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00811941
First received: December 18, 2008
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Alcohol Dependence
Drug: Placebo
Drug: Nalmefene
Phase 3

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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    Overview of AEs

  • Percentage of Patients Who Withdrew Due to Intolerance to Treatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).


Secondary Outcome Measures:
  • Drinking Risk Level (RSDRL) Response [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    GGT values

  • Liver Function Test Alanine Aminotransferase (ALAT) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    ALAT values

  • Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) [ Time Frame: Baseline and Month 13 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Month 13 ] [ Designated as safety issue: No ]
    TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).

  • Drinking Risk Level (RSDRL) Response [ Time Frame: Month 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    GGT values

  • Liver Function Test Alanine Aminotransferase (ALAT) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    ALAT values


Enrollment: 665
Study Start Date: March 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Selincro™

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811941

  Show 60 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00811941     History of Changes
Other Study ID Numbers: 12013A, 2007-002315-92
Study First Received: December 18, 2008
Results First Received: March 12, 2013
Last Updated: July 5, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by H. Lundbeck A/S:
Pharmacologic Actions
Alcohol-Related Disorders
Alcoholism
Mental Disorders
Central Nervous System Agents

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Central Nervous System Agents
Nalmefene
Therapeutic Uses
Pharmacologic Actions
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014