Alcohol DependencePhase 4NCT02197598
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use
A Phase 4 study testing nalmefene in people with Alcohol Dependence, run by H. Lundbeck A/S at 3 sites in Germany.
Trial summary
The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment. 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?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesGermany
- Study dates
- Sep 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- The patient has alcohol dependence, diagnosed at screening according to DSM-IV-TR™
- The patient has had an average alcohol consumption at, at least, a high drinking risk level (that is >60 g of alcohol/day for men and >40 g of alcohol/day for women) in the 4 weeks preceding the Screening Visit and in the period between the Screening and Inclusion Visits (that is, in the Screening Period)
- The patient has liver impairment defined by elevated liver stiffness and elevated liver enzymes at the Screening Visit (both criteria have to be fulfilled): liver stiffness (LS) as measured by Fibroscan >6 kPa, elevated transaminases (AST or ALT). Transaminase levels up to 5 times the upper limit of the reference range and γGT levels up to 10 times the upper limit of the reference range are allowed. At the discretion of the investigator, transaminase levels >5 times the upper limit of the reference range and γGT >10 times the upper limit of the reference range can be allowed if considered habitual for the patient, either confirmed by patient records or a repeat measurement during the Screening Period
- The patient has a breath alcohol concentration (BrAC) <0.02% at the Screening Visit.
- The patient provides a stable address and telephone number
- The patient is a man or woman, aged ≥ 18 years
- The patient has BMI≤30 kg/m2
Who cannot join
- The patient has any psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than alcohol dependence assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview , that in any way will interfere with the ability of the patient to take part in the study
- The patient has reported current use of, or has been tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates)
- The patient has severe liver impairment classified with a Child-Pugh Score C
- The patient has one or more clinical laboratory test values outside the reference range, based on the blood and urine samples taken at the Screening Visit, that are of potential risk to the patient's safety, or the patient has: Severe renal impairment (eGFR <30 mL/min per 1.73 m2), and/or Hypercholesterolemia with serum cholesterol levels > 300 mg/dL, (>7,758 mmol/L), and/or bilirubin > 3 mg/dL (50 μmol/L)
- The patient has had <6 heavy drinking days (HDDs, defined by the European Medicines Agency as a day with an alcohol consumption >60 g for men or >40 g for women) in the 4 weeks preceding the Screening Visit
- The patient has >5 consecutive abstinence days in the 4 weeks preceding the Screening Visit
- The patient has a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens)
- Other protocol-defined inclusion and exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Exploratory, Interventional, Open-label, Fixed-dose Study With Selincro® As-needed Use, in Alcohol Dependent Patients With Liver Impairment
The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.
- Conditions
- Alcohol Dependence
- Being tested
- nalmefene
- Keywords
- nalmefene, alcohol consumption, liver effects
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nalmefeneDrug
Also called Selincro®
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: nalmefene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the number of heavy drinking days per month (HDDs) (days/month)
Measured: Baseline to months 1, 2 and 3
Change from baseline in the number of HDDs per week (days/week)
Measured: Baseline to weeks 1 and 2
Change from baseline in total alcohol consumption (TAC) (g alcohol/day)
Measured: Baseline to months 1, 2 and 3
Change from baseline in TAC (g alcohol/day)
Measured: 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
Measured: Baseline to month 3
Response Low Drinking Risk Level (RLDRL)
Defined as a downward shift from baseline in DRL to low DRL or below
Measured: Baseline to month 3
Response defined as ≥70% reduction in TAC
Measured: Baseline to month 3
Response defined as 0 to 4 HDDs (days/month)
Measured: Month 3
Clinical Global Impression, global improvement (CGI-I).
Measured: Weeks 4 and 12
Change from baseline in Clinical Global Impression, Severity of illness (CGI-S)
Measured: Baseline to weeks 4 and 12
Change in the Short-Form 36-Item Health Survey (SF-36)
Measured: Baseline to week 12
Change in liver stiffness
Measured: Baseline to weeks 1,2 4 and 12
Category shift in fibrosis stage
Measured: Baseline to weeks 1,2 4, and 12
Change in transaminases and γ-glutamyl transferase (γGT)
Measured: Baseline to weeks 1,2,4,8, and 12
Change in bilirubin, albumin, and International Normalized Ratio (INR)
Measured: Baseline to weeks 1,2,4,8, and 12
Number of adverse events
Measured: Screening to week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H.Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197598
- Sponsor's protocol ID
- 15871A
- Other IDs
- 2014-000413-31, 2014
- Status last verified
- Dec 2016
- First submitted
- 21 Jul 2014
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory, Interventional, Open-label, Fixed-dose Study With Selincro® As-needed Use, in Alcohol Dependent Patients With Liver Impairment
- ClinicalTrials.gov ID
- NCT02197598
- Acronym / sponsor ID
- 15871A
- Conditions
- Alcohol Dependence
- Keywords
- nalmefene, alcohol consumption, liver effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selincro® (nalmefene) 18 mg, tablets | Experimental | Drug: nalmefeneOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient has alcohol dependence, diagnosed at screening according to DSM-IV-TR™
- The patient has had an average alcohol consumption at, at least, a high drinking risk level (that is >60 g of alcohol/day for men and >40 g of alcohol/day for women) in the 4 weeks preceding the Screening Visit and in the period between the Screening and Inclusion Visits (that is, in the Screening Period)
- The patient has liver impairment defined by elevated liver stiffness and elevated liver enzymes at the Screening Visit (both criteria have to be fulfilled): liver stiffness (LS) as measured by Fibroscan >6 kPa, elevated transaminases (AST or ALT). Transaminase levels up to 5 times the upper limit of the reference range and γGT levels up to 10 times the upper limit of the reference range are allowed. At the discretion of the investigator, transaminase levels >5 times the upper limit of the reference range and γGT >10 times the upper limit of the reference range can be allowed if considered habitual for the patient, either confirmed by patient records or a repeat measurement during the Screening Period
- The patient has a breath alcohol concentration (BrAC) <0.02% at the Screening Visit.
- The patient provides a stable address and telephone number
Key exclusion criteria (8 listed)
- The patient has any psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than alcohol dependence assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview , that in any way will interfere with the ability of the patient to take part in the study
- The patient has reported current use of, or has been tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates)
- The patient has severe liver impairment classified with a Child-Pugh Score C
- The patient has one or more clinical laboratory test values outside the reference range, based on the blood and urine samples taken at the Screening Visit, that are of potential risk to the patient's safety, or the patient has: Severe renal impairment (eGFR <30 mL/min per 1.73 m2), and/or Hypercholesterolemia with serum cholesterol levels > 300 mg/dL, (>7,758 mmol/L), and/or bilirubin > 3 mg/dL (50 μmol/L)
- The patient has had <6 heavy drinking days (HDDs, defined by the European Medicines Agency as a day with an alcohol consumption >60 g for men or >40 g for women) in the 4 weeks preceding the Screening Visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nalmefeneAlso: Selincro® | Drug | Selincro® (nalmefene) 18 mg, tablets |
Primary outcome
Change from baseline in the number of heavy drinking days per month (HDDs) (days/month)
Time frame: Baseline to months 1, 2 and 3
Change from baseline in the number of HDDs per week (days/week)
Time frame: Baseline to weeks 1 and 2
Change from baseline in total alcohol consumption (TAC) (g alcohol/day)
Time frame: Baseline to months 1, 2 and 3
Change from baseline in TAC (g alcohol/day)
Time frame: Baseline to weeks 1 and 2
Response Shift Drinking Risk Level (RSDRL)
Time frame: Baseline to month 3
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
Response Low Drinking Risk Level (RLDRL)
Time frame: Baseline to month 3
Defined as a downward shift from baseline in DRL to low DRL or below
Response defined as ≥70% reduction in TAC
Time frame: Baseline to month 3
Response defined as 0 to 4 HDDs (days/month)
Time frame: Month 3
Clinical Global Impression, global improvement (CGI-I).
Time frame: Weeks 4 and 12
Change from baseline in Clinical Global Impression, Severity of illness (CGI-S)
Time frame: Baseline to weeks 4 and 12
Change in the Short-Form 36-Item Health Survey (SF-36)
Time frame: Baseline to week 12
Change in liver stiffness
Time frame: Baseline to weeks 1,2 4 and 12
Category shift in fibrosis stage
Time frame: Baseline to weeks 1,2 4, and 12
Change in transaminases and γ-glutamyl transferase (γGT)
Time frame: Baseline to weeks 1,2,4,8, and 12
Change in bilirubin, albumin, and International Normalized Ratio (INR)
Time frame: Baseline to weeks 1,2,4,8, and 12
Number of adverse events
Time frame: Screening to week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H.Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nalmefene in people with Alcohol Dependence, run by H. Lundbeck A/S at 3 sites in Germany.
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 7 inclusion and 8 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 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 number of heavy drinking days per month (HDDs) (days/month) (time frame: Baseline to months 1, 2 and 3). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.