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    Summary
    EudraCT Number:2013-004688-30
    Sponsor's Protocol Code Number:15892A
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-004688-30
    A.3Full title of the trial
    Interventional, open-label study of 18 mg Selincro® as needed use, in the treatment of patients with alcohol dependence in primary care
    Estudio intervencionista y abierto sobre el uso de Selincro® 18 mg a demanda para el tratamiento de pacientes con dependencia del alcohol en la atención primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care
    Estudio sobre el uso de Selincro® 18 mg a demanda para el tratamiento de pacientes con dependencia del alcohol en la atención primaria
    A.4.1Sponsor's protocol code number15892A
    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.1.3.4CountryDenmark
    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.4.2CountryDenmark
    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 AddressAv. Diagonal, 605, 9°-1ª
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08028
    B.5.3.4CountrySpain
    B.5.4Telephone number34900 834 586
    B.5.6E-maillundbeckClinicalTrials@lundbeck.com
    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.2.1.1.1Trade name Selincro®
    D.2.1.1.2Name 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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Dependency
    Dependencia del Alcohol
    E.1.1.1Medical condition in easily understood language
    Alcohol Dependency
    Dependencia del Alcohol
    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 17.0
    E.1.2Level SOC
    E.1.2Classification code 10037175
    E.1.2Term Psychiatric disorders
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10001594
    E.1.2Term Alcohol dependence syndrome
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg
    Selincro® as-needed use, in conjunction with continuous psychosocial support in primary care (Cohort A).
    determinar la reducción del consumo de alcohol en pacientes con dependencia del alcohol tratados con Selincro® 18 mg a demanda junto con un apoyo psicosocial continuado en la atención primaria (cohorte A)
    E.2.2Secondary objectives of the trial
    -To evaluate the change in patients treated with 18 mg Selincro®, as-needed use, on clinical status, liver function, quality of life.
    -To determine the reduction in alcohol consumption in patients with alcohol dependence who reduce their
    alcohol consumption to below a high drinking risk level (according to WHO) in the screening period (and are therefore not eligible for Selincro® (nalmefene) treatment according to the Summary of Product Characteristics (SmPC)) (Cohort B).
    -To evaluate the psychometric properties of the Alcohol Quality of Life Scale (AQoLS).
    -To evaluate the safety and tolerability of 18 mg Selincro®, as-needed use, in primary care.
    − evaluar el cambio producido en pacientes tratados con Selincro® 18 mg a demanda en cuanto a:
    • estado clínico
    • función hepática
    • calidad de vida
    − determinar la reducción del consumo de alcohol en pacientes con dependencia del alcohol que reducen su consumo de alcohol por debajo del nivel de consumo de riesgo de alcohol alto (de acuerdo con la OMS) en el período de selección (y que por ello no son idóneos para el tratamiento con Selincro® (nalmefeno) de acuerdo con el Ficha Técnica (FT) (cohorte B)
    − evaluar las propiedades psicométricas de la Escala de calidad de vida para la dependencia del alcohol (Alcohol Quality of Life Scale, AQoLS)
    − evaluar la seguridad y la tolerabilidad de Selincro® 18 mg a demanda en la atención primaria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patient has alcohol dependence diagnosed according to ICD-10.
    • The patient has had a high DRL in the 4 weeks preceding the Screening Visit.
    • The patient is a man or woman, aged ≥18 years.
    • The patient provides a stable address and telephone number.
    El paciente tiene dependencia del alcohol diagnosticada conforme a CIE-10 (F10.24 y F10.25)
    El paciente ha tenido un consumo promedio de alcohol en niveles de riesgo altos (esto es, > 60 g de alcohol/día para los hombres y > 40 g de alcohol/día para las mujeres) en las 4 semanas anteriores a la visita de selección.
    El paciente es varón o mujer de ≥ 18 años de edad.
    El paciente facilita una dirección y número de teléfono fijos.
    E.4Principal exclusion criteria
    • The patient has one or more contraindications to the prescription of Selincro®:
    a. hypersensitivity to the active substance or to any of the excipients,
    b. taking opioid analgesics,
    c. current or recent opioid addiction,
    d. acute symptoms of opioid withdrawal,
    e. recent use of opioids suspected,
    f. severe hepatic impairment (Child-Pugh classification),
    g. severe renal impairment (eGFR <30 ml/min per 1.73 m2),
    h. a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens).

    • The patient has had <6 HDDs (defined by the European Medicines Agency as a day with an alcohol consumption >60g for men or >40g for women) in the 4 weeks preceding the Screening Visit.

    • The patient has physical alcohol withdrawal symptoms and requires immediate detoxification for which inpatient treatment is required.

    • The patient is currently participating or has recently (in the 4 weeks preceding the Screening Visit) participated in a treatment or support programme for alcohol-use disorders, including Alcohol Anonymous, detoxification treatment, and treatment of alcohol withdrawal symptoms, or the patient is already taking nalmefene or has taken nalmefene in the 6 months preceding the Screening Visit.
    - El paciente tiene una o más de las siguientes contraindicaciones para la prescripción de Selincro®:
    a. hipersensibilidad al principio activo o a alguno de los excipientes,
    b. estar tomando analgésicos opiáceos,
    c. adicción actual o reciente a los opiáceos,
    d. síntomas agudos de abstinencia de opiáceos,
    e. sospecha de uso reciente de opiáceos,
    f. insuficiencia hepática grave (clasificación de Child-Pugh), según se especifica en el Apéndice V),
    g. insuficiencia renal grave (TFGe < 30 ml/min por 1,73 m2),
    h. antecedentes recientes de síndrome de abstinencia del alcohol agudo (que incluya alucinaciones, convulsiones o delirium tremens).

    - El paciente ha tenido < 6 días de consumo excesivo (DCE) de alcohol durante las 4 semanas anteriores a la visita de selección. Se define un DCE como un día con un consumo de alcohol > 60 gramos (hombres) o > 40 gramos (mujeres)

    - El paciente tiene síntomas físicos de abstinencia del alcohol y requiere una desintoxicación inmediata para la que es necesario un tratamiento con hospitalización

    - El paciente está participando o ha participado recientemente (en las 4 semanas anteriores a la visita de selección) en un programa de tratamiento o de apoyo para trastornos derivados del consumo de alcohol, incluidos Alcohólicos Anónimos, tratamiento de desintoxicación o tratamiento de los síntomas de abstinencia del alcohol (pero se permite la participación en un grupo de autoayuda), o está tomando ya nalmefeno o lo ha tomado en los 6 meses anteriores a la visita de selección
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Measure:
    • Change in the number of Heavy Drinking Days (HDDs) (days/month) [Cohort A]
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Outcome Measure:
    • Change in the number of Heavy Drinking Days (HDDs) (days/month) [Cohort A] Time Frame: Baseline to Month 3
    E.5.2Secondary end point(s)
    Secondary Outcome Measures:
    • Change in Total Alcohol Consumption (TAC) (g/day) [Cohort A]
    • Drinking Risk Level response (RSDRL); defined as a downward shift in Drinking Risk Level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or below; for patients with a high DRL at baseline, a shift to low DRL or below [Cohort A]
    • RLDRL response; defined as a downward shift in DRL to low DRL or below [Cohort A]
    • Response defined as ≥70% reduction in TAC Month 3 [Cohort A]
    • Response defined as 0 to 4 HDDs (days/month) [Cohort A]
    • Change in Clinical Global Impression - Severity of Illness (CGI-S) score [Cohort A]
    • Clinical Global Impression - Global Improvement (CGI-I) [Cohort A]
    • y-glutamyl transferase (y-GT) [Cohort A]
    • Alanine aminotransferase (ALT) [Cohort A]
    • Aspartate aminotransferase (AST) [Cohort A]
    • Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom) [Cohort A]
    • Change in Alcohol Quality of Life Scale (AQoLS) (only for patients in France and the United Kingdom) [Cohort A]
    • Change in the number of HDDs (days/month) [Cohort B]
    • Change in TAC (g/day) [Cohort B]
    • Adverse events [Cohorts A and B]
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Outcome Measures:
    • Change in TAC [Cohort A] - Baseline to Month 3
    • RSDRL [Cohort A] - Baseline to Month 3
    • RLDRL [Cohort A] - Baseline to Month 3]
    • Response: ≥70% reduction in TAC [Cohort A] - Baseline to Month 3
    • Response: 0 to 4 HDDs (days/month) [Cohort A] - Month 3
    • CGI-S score [Cohort A] - Baseline to Week 12
    • CGI-I [Cohort A] - Week 12
    • y-GT [Cohort A] - Week 12
    • ALT [Cohort A] - Week 12
    • AST [Cohort A] - Week 12
    • Change in SF-36 (France, UK) [Cohort A] - Baseline to Week 12
    • Change in AQoLS (France, UK) [Cohort A] - Baseline to Week 12
    • Change in the number of HDDs (days/month) [Cohort B] - Baseline to Month 3
    • Change in TAC [Cohort B] - Baseline to Month 3
    • Adverse events [Cohorts A and B] - Up to Week 12
    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.7.1.3.1Other 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 No
    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.8.3 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    LVLS
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 620
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-06-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state127
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 635
    F.4.2.2In the whole clinical trial 635
    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 all countries. 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 Decision2014-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
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