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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002563-27 | EudraCT Number |
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The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Nalmefene | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | as-needed use, tablets, orally, 6 months |
| |
| Nalmefene |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Month 6 |
| 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). | Baseline and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 |
| Change From Baseline in Clinical Status Using CGI-S |
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Inclusion Criteria:
In- and outpatients who:
Exclusion Criteria:
The patient:
Other protocol-defined inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BE002 | Assebroek | 8310 | Belgium | |||
| BE007 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23562264 | Result | 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. | |
| 25832297 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | as-needed use, tablets, orally, 6 months |
| FG001 | Nalmefene 18.06 mg | as-needed use, tablets, orally, 6 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| All Randomised Patients |
|
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| Drug |
18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride. |
|
|
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 |
| 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). | Week 24 |
| Liver Function Test Gamma-glutamyl Transferase (GGT) | GGT values | Week 24 |
| Liver Function Test Alanine Aminotransferase (ALAT) | ALAT values | Week 24 |
| Bruges |
| 8000 |
| Belgium |
| BE006 | Charleroi | 6000 | Belgium |
| BE005 | Kortenberg | 3070 | Belgium |
| BE001 | Liège | 4000 | Belgium |
| BE003 | Mechelen | 2800 | Belgium |
| BE004 | Ostend | 8400 | Belgium |
| CZ001 | Litoměřice | 41201 | Czechia |
| CZ002 | Prague | 100 00 | Czechia |
| CZ003 | Prague | 160 00 | Czechia |
| FR008 | Angers | 4933 | France |
| FR004 | Bully-les-Mines | 62160 | France |
| FR009 | Clichy | 92110 | France |
| FR012 | Élancourt | 78990 | France |
| FR021 | La Rochelle | 17022 | France |
| FR011 | Le Pecq | 78230 | France |
| FR019 | Lille | 59037 | France |
| FR016 | Lyon | 69005 | France |
| FR014 | Nancy | 54000 | France |
| FR015 | Nîmes | 30029 | France |
| FR002 | Rennes | 35000 | France |
| FR001 | Sartrouville | 78500 | France |
| FR007 | Strasbourg | 67000 | France |
| FR005 | Toulouse | 31000 | France |
| FR006 | Toulouse | 31200 | France |
| FR003 | Villejuif | 94804 | France |
| IT017 | Bologna | 40123 | Italy |
| IT013 | Bologna | 44042 | Italy |
| IT008 | Cento | 44042 | Italy |
| IT006 | Florence | 50134 | Italy |
| IT002 | Parma | 43100 | Italy |
| IT007 | Rome | 00123 | Italy |
| IT001 | Rome | 00163 | Italy |
| IT011 | Rome | RM 00168 | Italy |
| IT004 | Rome | RM 00186 | Italy |
| IT018 | Soverato Marina | CZ 88068 | Italy |
| PL005 | Gdansk | 80-952 | Poland |
| PL004 | Leszno | 64-100 | Poland |
| PL006 | Lublin | 20-109 | Poland |
| PL007 | Lublin | 20-442 | Poland |
| PL002 | Piekary Śląskie | 41940 | Poland |
| PL003 | Skorzewo | 60-185 | Poland |
| PL001 | Szczecin | 71-460 | Poland |
| PT003 | Angra do Heroísmo | 9700-161 | Portugal |
| PT002 | Lisbon | 1350-179 | Portugal |
| PT001 | Lisbon | 1649-035 | Portugal |
| PT006 | Mem Martins | 2725 | Portugal |
| ES005 | Alicante | 3550 | Spain |
| ES006 | Barcelona | 8003 | Spain |
| ES008 | Barcelona | 8025 | Spain |
| ES004 | Barcelona | 8028 | Spain |
| ES014 | Burgos | 9006 | Spain |
| ES010 | Madrid | 28034 | Spain |
| ES001 | Mallorca | 7193 | Spain |
| ES002 | Oviedo | 33011 | Spain |
| ES003 | Valencia | 46010 | Spain |
| ES011 | Zamora | 49021 | Spain |
| 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. |
| 25227627 | Derived | 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. |
| 23873853 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| All Treated Patients |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | as-needed use, tablets, orally, 6 months |
| BG001 | Nalmefene 18.06 mg | as-needed use, tablets, orally, 6 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | All-patients-randomised set (APRS). | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | APRS. | Count of Participants | Participants |
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| Previously Treated for Alcohol Dependence | APRS | Number | participants |
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| Previously Treated for Alcohol Withdrawal Symptoms] | APRS. | Number | participants |
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| Total Monthly Heavy Drinking Days (HDD) | APRS. Based on Timeline Followback (TLFB) data from the month preceding the screening visit. | Mean | Standard Deviation | days |
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| Total Alcohol Consumption (TAC) g Alcohol/Day | APRS. Based on TLFB data from the month preceding the screening visit. | Mean | Standard Deviation | g |
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| Drinking Risk Level (DRL) | APRS. | Number | participants |
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| Clinical Global Impression - Severity of Illness (CGI-S) | APRS. 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). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Gamma-glutamyl Transferase (GGT) | APRS. | Mean | Standard Deviation | international units per liter (IU/L) |
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| Alanine Aminotransferase (ALAT) | APRS. | Mean | Standard Deviation | IU/L |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline. | Posted | Mean | Standard Error | days | Baseline and Month 6 |
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| Primary | 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). | FAS | Posted | Mean | Standard Error | g | Baseline and Month 6 |
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| Secondary | 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. | FAS | Posted | Number | percentage of participants | Month 6 |
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| Secondary | 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). | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 24 |
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| Secondary | 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). | FAS | Posted | Mean | Standard Error | units on a scale | Week 24 |
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| Secondary | Liver Function Test Gamma-glutamyl Transferase (GGT) | GGT values | FAS | Posted | Geometric Mean | Geometric Coefficient of Variation | IU/L | Week 24 |
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| Secondary | Liver Function Test Alanine Aminotransferase (ALAT) | ALAT values | FAS | Posted | Geometric Mean | Geometric Coefficient of Variation | IU/L | Week 24 |
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Serious Adverse Events: 24 weeks, a 4-week run-out period, 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: 24 weeks and a 4-week run-out period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | as-needed use, tablets, orally, 6 months | 14 | 337 | 102 | 337 | ||
| EG001 | Nalmefene 18.06 mg | as-needed use, tablets, orally, 6 months | 7 | 341 | 157 | 341 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Meddra 13.0 | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | Meddra 13.0 | Non-systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | Meddra 13.0 | Non-systematic Assessment |
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| Sudden death | General disorders | Meddra 13.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | Meddra 13.0 | Non-systematic Assessment |
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| Pyothorax | Infections and infestations | Meddra 13.0 | Non-systematic Assessment |
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| Subcutaneous abscess | Infections and infestations | Meddra 13.0 | Non-systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | Meddra 13.0 | Non-systematic Assessment |
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| Alcohol poisoning | Injury, poisoning and procedural complications | Meddra 13.0 | Non-systematic Assessment |
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| Drug toxicity | Injury, poisoning and procedural complications | Meddra 13.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Meddra 13.0 | Non-systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | Meddra 13.0 | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | Meddra 13.0 | Non-systematic Assessment |
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| Intentional overdose | Injury, poisoning and procedural complications | Meddra 13.0 | Non-systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | Meddra 13.0 | Non-systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | Meddra 13.0 | Non-systematic Assessment |
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| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Meddra 13.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Meddra 13.0 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | Meddra 13.0 | Non-systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | Meddra 13.0 | Non-systematic Assessment |
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| Alcoholism | Psychiatric disorders | Meddra 13.0 | Non-systematic Assessment |
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| Suicidal behaviour | Psychiatric disorders | Meddra 13.0 | Non-systematic Assessment |
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| Arteritis | Vascular disorders | Meddra 13.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | Meddra 13.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Meddra 13.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Meddra 13.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Meddra 13.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Meddra 13.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Meddra 13.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | Meddra 13.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Meddra 13.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Meddra 13.0 | Non-systematic Assessment |
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The main publication has to be published before any sub publication. The investigators shall obtain Lundbeck's written approval before publishing any publication relating to nalmefene, the Study, the Protocol and/or the results recorded during the Study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck A/S | H. Lundbeck A/S | +45 3630 1311 | LundbeckClinicalTrials@lundbeck.com |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019973 | Alcohol-Related Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C038981 | nalmefene |
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| Non-compliance |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Other Reason |
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| Male |
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| YES |
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| UNKNOWN |
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| YES |
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| UNKNOWN |
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| Medium |
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| High |
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| Very High |
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| No |
| Superiority or Other |
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