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Alcohol DependencePhase 3ESENSE2NCT00812461

Efficacy of Nalmefene in Patients With Alcohol Dependence

A Phase 3 study testing Nalmefene in people with Alcohol Dependence, run by H. Lundbeck A/S at 57 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Dependence
What is being tested?
Nalmefene
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
678 participants
Where
57 sitesin 7 countries
Study dates
Mar 2009to Apr 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • reported current or recent treatment with antipsychotics or antidepressants
  • was pregnant or breast-feeding
  • Other protocol-defined inclusion and exclusion criteria may apply.

Trial locations and contacts

57 sites in 7 countries.

57 sites in 7 countries

France16 sites

  • FR008

    Angers, 4933

  • FR004

    Bully-les-Mines, 62160

  • FR009

    Clichy, 92110

  • FR012

    Élancourt, 78990

  • FR021

    La Rochelle, 17022

  • FR011

    Le Pecq, 78230

  • FR019

    Lille, 59037

  • FR016

    Lyon, 69005

  • FR014

    Nancy, 54000

  • FR015

    Nîmes, 30029

  • FR002

    Rennes, 35000

  • FR001

    Sartrouville, 78500

  • FR007

    Strasbourg, 67000

  • FR005

    Toulouse, 31000

  • FR006

    Toulouse, 31200

  • FR003

    Villejuif, 94804

Other trials in France

Italy10 sites

  • IT017

    Bologna, 40123

  • IT013

    Bologna, 44042

  • IT008

    Cento, 44042

  • IT006

    Florence, 50134

  • IT002

    Parma, 43100

  • IT007

    Rome, 00123

  • IT001

    Rome, 00163

  • IT011

    Rome, RM 00168

  • IT004

    Rome, RM 00186

  • IT018

    Soverato Marina, CZ 88068

Other trials in Italy

Spain10 sites

  • ES005

    Alicante, 3550

  • ES006

    Barcelona, 8003

  • ES008

    Barcelona, 8025

  • ES004

    Barcelona, 8028

  • ES014

    Burgos, 9006

  • ES010

    Madrid, 28034

  • ES001

    Mallorca, 7193

  • ES002

    Oviedo, 33011

  • ES003

    Valencia, 46010

  • ES011

    Zamora, 49021

Other trials in Spain

Belgium7 sites

  • BE002

    Assebroek, 8310

  • BE007

    Bruges, 8000

  • BE006

    Charleroi, 6000

  • BE005

    Kortenberg, 3070

  • BE001

    Liège, 4000

  • BE003

    Mechelen, 2800

  • BE004

    Ostend, 8400

Other trials in Belgium

Poland7 sites

  • PL005

    Gdansk, 80-952

  • PL004

    Leszno, 64-100

  • PL006

    Lublin, 20-109

  • PL007

    Lublin, 20-442

  • PL002

    Piekary Śląskie, 41940

  • PL003

    Skorzewo, 60-185

  • PL001

    Szczecin, 71-460

Other trials in Poland

Portugal4 sites

  • PT003

    Angra do Heroísmo, 9700-161

  • PT002

    Lisbon, 1350-179

  • PT001

    Lisbon, 1649-035

  • PT006

    Mem Martins, 2725

Other trials in Portugal

Czechia3 sites

  • CZ001

    Litoměřice, 41201

  • CZ002

    Prague, 100 00

  • CZ003

    Prague, 160 00

Other trials in Czechia

About this study

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

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

Read the 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.

Being tested
Placebo, Nalmefene
Keywords
Pharmacologic Actions, Alcohol-Related Disorders, Alcoholism, Mental Disorders, Central Nervous System Agents
Medical subject headings
Alcoholism, Alcohol-Related Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    as-needed use, tablets, orally, 6 months

  • NalmefeneDrug

    Also called Selincro™

    18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Study groups in NCT00812461
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
NalmefeneExperimentalNot described
Receives: Drug: Nalmefene

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Month 6

  2. 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).

    Measured: Baseline and Month 6

Secondary outcomes (5)

  1. 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.

    Measured: Month 6

  2. 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).

    Measured: Baseline and Week 24

  3. 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).

    Measured: Week 24

  4. Liver Function Test Gamma-glutamyl Transferase (GGT)

    GGT values

    Measured: Week 24

  5. Liver Function Test Alanine Aminotransferase (ALAT)

    ALAT values

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2008 (estimated)
  2. Study startMar 2009
  3. Primary completionMar 2011
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
678 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00812461
Sponsor's protocol ID
12023A
Other IDs
2007-002563-27
Acronym
ESENSE2
Status last verified
Jul 2013
First submitted
19 Dec 2008
Last updated
22 Jul 2013
Data monitoring committee
No

Publications

  • 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.

    PubMed 23562264

  • 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.

    PubMed 25832297

  • 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.

    PubMed 25227627

  • 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.

    PubMed 23873853

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nalmefene in people with Alcohol Dependence, run by H. Lundbeck A/S at 57 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in France, Italy, Spain, Belgium, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) (time frame: Baseline and Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00812461, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2013.

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