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    EudraCT Number:2014-000413-31
    Sponsor's Protocol Code Number:15871A
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-23
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2014-000413-31
    A.3Full title of the trial
    Exploratory, interventional, open-label, fixed-dose study with Selincro® as-needed use, in alcohol dependent patients with liver impairment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of patients suffering of alcohol dependence and impaired liver function with Selincro® as-needed use
    A.4.1Sponsor's protocol code number15871A
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/293/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorH. Lundbeck A/S
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportH. Lundbeck A/S
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationH. Lundbeck A/S
    B.5.2Functional name of contact pointLundbeckClinicalTrials@lundbeck.com
    B.5.3 Address:
    B.5.3.1Street AddressOttiliavej 9
    B.5.3.2Town/ cityValby
    B.5.3.3Post code2500
    B.5.4Telephone number+4536301311
    B.5.5Fax number+4536301940
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name Selincro®
    D. of the Marketing Authorisation holderH. Lundbeck A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNalmefene
    D.3.9.1CAS number 55096-26-9
    D.3.9.3Other descriptive nameNALMEFENE HYDROCHLORIDE DIHYDRATE
    D.3.9.4EV Substance CodeSUB130094
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18.06
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alcohol dependence and liver impairment related to alcohol consumption
    E.1.1.1Medical condition in easily understood language
    Alcohol dependence with impaired liver function related to alcohol consumption
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10001594
    E.1.2Term Alcohol dependence syndrome
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10021520
    E.1.2Term Impaired liver function
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Exploratory objectives to be assessed in patients with alcohol dependence and liver impairment treated with 18 mg Selincro® (nalmefene), as-needed, over 12 weeks:
    - To explore the reduction of alcohol consumption
    - To explore the change in liver stiffness
    - To explore the change in Controlled Attenuation Parameter (CAP)
    - To explore the change in liver enzymes
    - To explore the shift in fibrosis stage
    - To explore the associations between reduction of alcohol consumption, liver stiffness, CAP and liver enzymes

    To explore the change in patients with alcohol dependence and liver impairment treated with 18 mg Selincro® (nalmefene), as-needed, on:
    - Clinical Global Impression
    - Quality of life

    Safety objective:
    To evaluate safety and tolerability of 18 mg Selincro® (nalmefene), as-needed, in patients with alcohol dependence and liver impairment
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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 changes defined by elevated liver stiffness or elevated controlled attenuation parameter (CAP) at the Screening Visit.
    - liver stiffness (LS) >6 kPa or CAP >215 dB/m measured by Fibroscan

    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
    E.4Principal exclusion criteria
    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, see Panel 4 of the protocol.

    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
    - Transaminase levels above 5 times the upper limit of the reference range and γGT levels above 10 times the upper limit of the reference range are not allowed unless if considered habitual for the patient by the Investigator, either confirmed by patient records or a repeat measurement during the Screening Period.

    The patient has or has had one or more of the following conditions that is/are considered clinically relevant in the context of the study:
    − seizure disorder or encephalopathy, and/or
    − endocrine disorder : newly diagnosed or unstable diabetes I and II defined by:
    o The patient has not previously been diagnosed with diabetes, but meets the following criteria (newly diagnosed diabetes):
    - HbA1c >6.5% AND
    - Fasting plasma glucose >126 mg/dL (7.0 mmol/L)
    If only one parameter is abnormal a retest is mandatory. A new abnormal result is considered as an exclusion.
    o The patient has previously been diagnosed with diabetes, but the condition is unstable as determined by the following criteria
    - HbA1c >8.0 %

    - 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 a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens).

    - The patient is, in the opinion of the investigator, at significant risk of suicide

    - The patient is currently participating in or has recently completed (within 1 month prior to the Screening Visit) a treatment or support programme for alcohol-use disorders, including Alcohol Anonymous, (participation in a self-support group is allowed), detoxification treatment, and treatment of alcohol withdrawal symptoms

    - The patient’s immediate treatment goal is abstinence.

    - The patient has physical withdrawal symptoms and requires immediate detoxification
    E.5 End points
    E.5.1Primary end point(s)
    ● The therapeutic effect on the reduction of alcohol consumption will be evaluated by
    - change from baseline in the number of heavy drinking days (HDDs)
    - change from baseline in total alcohol consumption (TAC)
    - Response Shift Drinking Risk Level (RSDRL) response: 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) response: defined as a downward shift from baseline in DRL to low DRL or below
    - response defined as ≥70% reduction in TAC
    - response defined as 0 to 4 HDDs (days/month)

    ● The therapeutic effect on the change in liver stiffness will be evaluated by measurement of liver stiffness and category shift in fibrosis stage.

    ● The therapeutic effect on the change in controlled attenuation parameter (CAP) will be evaluated by measurement of CAP and category shift in steatosis stage.

    ● The therapeutic effect on liver function will be evaluated by measurement of transaminases, γ-glutamyl transferase (γGT), change from baseline in bilirubin, albumin, and International Normalized Ratio (INR).

    ● The clinical global impression will be assessed by two clinician-rated scales: severity of illness (CGI-S) and global improvement (CGI-I).

    ● The health-related quality of life will be assessed by a patient self-rated questionnaire, Short-Form 36-Item Health Survey (SF-36).

    ● Safety will be evaluated by adverse events (AEs), clinical safety laboratory tests, vital signs and weight.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ● Reduction of alcohol consumption:
    - Change from baseline in the number HDDs at Month 3
    - Change from baseline in TAC at Month 3
    - RSDRL response at Month 3
    - RLDRL response at Month 3
    - ≥70% reduction in TAC at Month 3
    - 0 to 4 HDDs (days/month) at Month 3

    ● Measurement of liver stiffness and category shift in fibrosis at Week 12.

    ● Measurement of controlled attenuation parameter and category shift in steatosis at Week 12.

    ● Measurement of liver function: transaminases, γ-glutamyl transferase (γGT); change from baseline in bilirubin, albumin, and INR at Week 12.

    ● Clinical global impression: CGI-S and CGI-I at Week 12.

    ● Health-related quality of life: SF-36 at Week 12.

    ● Safety endpoints: changes from baseline.
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study for an individual patient is defined as the last protocol-specified contact with that patient. The overall end of the study is defined as the last protocol-specified contact with the last patient ongoing in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Selincro® will be commercially available in Germany. The patient's response to treatment and the need for continued Selincro® treatment should be evaluated at the end of the study. Treatment may be continued based on the investigator's judgement and the patient's treatment goal, if it is in the best interest of the patient.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-04
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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