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Alcohol DependencePhase 3SENSENCT00811941

Safety and 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 60 sites in 10 countries.

Completed

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

Official record
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Trial summary

The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with 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
665 participants
Where
60 sitesin 10 countries
Study dates
Mar 2009to Nov 2010
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 Heavy Drinking Days (HDDs) in the 4 weeks preceding the Screening Visit

Who cannot join

  • 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.

Trial locations and contacts

60 sites in 10 countries.

60 sites in 10 countries

Poland15 sites

  • PL015

    Bełchatów, 97-400

  • PL008

    Bydgoszcz, 85-096

  • PL006

    Gdansk, 80-211

  • PL011

    Krakow, 31-826

  • PL002

    Leszno, 64-100

  • PL010

    Lodz, 91-229

  • PL014

    Lodz, 91-229

  • PL004

    Lublin, 20-015

  • PL005

    Lublin, 20-109

  • PL013

    Piekary Śląskie, 41-940

  • PL003

    Skorzewo, 60-185

  • PL007

    Starogard Gdański, 83-200

  • PL012

    Swicie n/Wisla, 86-100

  • PL009

    Szczecin, 71-460

  • PL001

    Torun, 87-100

Other trials in Poland

Ukraine10 sites

  • UA001

    Chernihiv, 14000

  • UA008

    Dnipropetrovsk, 49616

  • UA003

    Donetsk, 83037

  • UA004

    Hlevakha, 8630

  • UA007

    Kharkiv, 61068

  • UA009

    Kherson, 73488

  • UA002

    Kyiv, 4080

  • UA005

    Odesa, 65006

  • UA006

    Simferopol, 95006

  • UA010

    Ternopil, 46020

Other trials in Ukraine

Russia8 sites

  • RU013

    Rostov-on-Don, 344010

  • RU002

    Saint Petersburg, 18861

  • RU005

    Saint Petersburg, 192019

  • RU006

    Saint Petersburg, 192019

  • RU001

    Saint Petersburg, 193015

  • RU012

    Saint Petersburg, 194022

  • RU003

    Saint Petersburg, 197198

  • RU004

    Voronezh, 394000

Other trials in Russia

Czechia5 sites

  • CZ007

    Litoměřice, 412 01

  • CZ006

    Lnáře, 38742

  • CZ005

    Prague, 100 00

  • CZ004

    Prague, 160 00

  • CZ001

    Ústí nad Labem, 400 13

Other trials in Czechia

Estonia5 sites

  • EE002

    Pärnu, 80012

  • EE004

    Tallinn, 10613

  • EE005

    Tallinn, 10613

  • EE001

    Võru, 65608

  • EE003

    Vorumaa, 65526

Other trials in Estonia

United Kingdom5 sites

  • GB007

    Birmingham, B15 2SQ

  • GB006

    Glasgow

  • GB009

    London

  • GB008

    Manchester, M15 6SX

  • GB005

    Reading, RG2 0TG

Other trials in United Kingdom

Latvia4 sites

  • LV003

    Daugavpils, 5403

  • LV002

    Jelgava, 3008

  • LV001

    Riga, 1013

  • LV004

    Sigulda, 2150

Other trials in Latvia

Slovakia4 sites

  • SK001

    Banska Bysterica, 974 01

  • SK002

    Krupina, 963 01

  • SK004

    Nitra, 949 01

  • SK005

    Rimavská Sobota, 97912

Other trials in Slovakia

Hungary2 sites

  • HU004

    Budapest, 1135

  • HU002

    Budapest, 1163

Other trials in Hungary

Lithuania2 sites

  • LT002

    Kaunas, 44184

  • LT003

    Kaunas, 50185

Other trials in Lithuania

About this study

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

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

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, 52 weeks

  • NalmefeneDrug

    Also called Selincro™

    18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Study groups in NCT00811941
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. Number of Patients With Adverse Events (AEs)

    Overview of AEs

    Measured: 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.

  2. Percentage of Patients Who Withdrew Due to Intolerance to Treatment

    Measured: Baseline to Week 52

  3. 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

  4. 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 (12)

  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

  6. 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.

    Measured: Baseline and Month 13

  7. 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 13

  8. 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 13

  9. 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 52

  10. 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 52

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

    GGT values

    Measured: Week 52

  12. Liver Function Test Alanine Aminotransferase (ALAT)

    ALAT values

    Measured: Week 52

Timeline

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

  1. First posted19 Dec 2008 (estimated)
  2. Study startMar 2009
  3. Primary completionNov 2010
  4. Study completionNov 2010

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
665 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00811941
Sponsor's protocol ID
12013A
Other IDs
2007-002315-92
Acronym
SENSE
Status last verified
Jul 2013
First submitted
18 Dec 2008
Last updated
7 Aug 2013
Data monitoring committee
No

Publications

  • 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

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 60 sites in 10 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 3 inclusion and 7 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 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Poland, Ukraine, Russia, Czechia, Estonia and 5 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 7 Aug 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?

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.). The study lists 4 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 NCT00811941, which also lists 1 linked publication.

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 7 Aug 2013.

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