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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000413-31 | EudraCT Number |
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The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selincro® (nalmefene) 18 mg, tablets | Experimental | One tablet orally for 12 weeks on days when the patient perceives a risk of drinking alcohol, preferably 1-2 hours prior to the anticipated risk of drinking. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nalmefene | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the number of heavy drinking days per month (HDDs) (days/month) | Baseline to months 1, 2 and 3 | |
| Change from baseline in the number of HDDs per week (days/week) | Baseline to weeks 1 and 2 | |
| Change from baseline in total alcohol consumption (TAC) (g alcohol/day) | Baseline to months 1, 2 and 3 | |
| Change from baseline in TAC (g alcohol/day) | Baseline to weeks 1 and 2 | |
| Response Shift Drinking Risk Level (RSDRL) | Defined as a downward shift from baseline in drinking risk level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or lower; for patients with a high DRL at baseline, a shift to low DRL or below | Baseline to month 3 |
| Response Low Drinking Risk Level (RLDRL) | Defined as a downward shift from baseline in DRL to low DRL or below | Baseline to month 3 |
| Response defined as ≥70% reduction in TAC | Baseline to month 3 | |
| Response defined as 0 to 4 HDDs (days/month) | Month 3 | |
| Clinical Global Impression, global improvement (CGI-I). | Weeks 4 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| DE001 | Heidelberg | Germany | ||||
| DE002 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 2014-000413-31 | EMA EudraCT Results | View IPD |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C038981 | nalmefene |
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| Change from baseline in Clinical Global Impression, Severity of illness (CGI-S) | Baseline to weeks 4 and 12 |
| Change in the Short-Form 36-Item Health Survey (SF-36) | Baseline to week 12 |
| Change in liver stiffness | Baseline to weeks 1,2 4 and 12 |
| Category shift in fibrosis stage | Baseline to weeks 1,2 4, and 12 |
| Change in transaminases and γ-glutamyl transferase (γGT) | Baseline to weeks 1,2,4,8, and 12 |
| Change in bilirubin, albumin, and International Normalized Ratio (INR) | Baseline to weeks 1,2,4,8, and 12 |
| Number of adverse events | Screening to week 14 |
| Mannheim |
| Germany |
| Optuminisight | München | Germany |
| D004327 | Drinking Behavior |
| D001519 | Behavior |