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    Summary
    EudraCT Number:2007-002315-92
    Sponsor's Protocol Code Number:12013A
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-17
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2007-002315-92
    A.3Full title of the trial
    A 52-week, randomised, double-blind, placebo-controlled, parallel-group, safety and tolerability study of nalmefene, as needed use, in patients with alcohol dependence
    A.4.1Sponsor's protocol code number12013A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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.3.1Product nameNalmefene
    D.3.2Product code Lu AA 36143
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 55096269
    D.3.9.2Current sponsor codeLu AA36143
    D.3.9.3Other descriptive nameNALMEFENE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alcohol dependence
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001594
    E.1.2Term Alcohol dependence syndrome
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long term safety and tolerability of as needed use of 20 mg nalmefene versus placebo over a period of 52 weeks in patients with alcohol dependence.
    E.2.2Secondary objectives of the trial
    To evaluate the therapeutic effect of as needed use of 20 mg nalmefene versus placebo over a period of 52 weeks in patients with alcohol dependence, on:
    - reduction of alcohol consumption
    - alcohol dependence symptoms and clinical status
    - liver function and other biological laboratory tests
    - pharmacoeconomic outcomes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient is able to read and understand the Subject Information Sheet.
    2. The patient has signed the Informed Consent Form.
    3. The patient has a BAC of < 0.02% at the screening visit.
    4. The patient has a diagnosis of alcohol dependence (diagnostic code 303.90) according to DSM-IV-TR.
    5. The patient is a man or a woman, aged 18 years or over.
    6. The patient provides a stable address and telephone number.
    7. The patient provides an identified locator person that can be contacted during the study in the event of loss of contact.
    8. The patient, if female, must:
    - agree not to try to become pregnant during the study, and
    - use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide), or
    - have had her last natural menstruation at least 24 months prior to baseline, or
    - have been surgically sterilised prior to baseline, or
    - have had a hysterectomy prior to baseline, or
    - not be sexually active with men.
    E.4Principal exclusion criteria
    1. The patient has less than 6 heavy drinking days (HDD) in the 4 weeks preceding the screening visit. A HDD is defined as a day of alcohol consumption with 60 g or more for males and 40 g or more for females.
    2. The patient has more than 14 consecutive abstinent days in the 4 weeks preceding the screening visit.
    3. The patient has a CIWA-Ar score of 10 or more.
    4. The patient has a severe psychiatric disorder (such as psychosis, schizophrenia, severe depression, eating disorders, bipolar disorder), antisocial personality disorder or other disorders for which the treatment takes priority over treatment of the drinking problem, or is likely to interfere with study treatment or impairs treatment compliance.
    5. The patient has risk of suicide evaluated by the suicidality module of MINI (the patient answers ‘yes’ to any of the questions C2, C3, C4, C5, or C6).
    6. The patient has a history of delirium tremens or alcohol withdrawal seizures.
    7. The patient has a cognitive impairment which judged by the investigator is likely to
    interfere with the patient’s understanding of the study and its procedures.
    8. The patient reports or urine drug screen reveals current use of substances of abuse other than alcohol, cannabis, nicotine or benzodiazepines.
    9. The patient has seizure disorder, mental retardation, or encephalopathy in the medical history.
    10. The patient has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolic disturbance.
    11. The patient has clinically significant abnormal vital signs.
    12. The patient has S-ASAT and/or S-ALAT levels greater than 3 times of upper normal limit, or one or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.
    13. The patient has clinically significant abnormal findings in ECG.
    14. The patient has a history of severe drug allergy or hypersensitivity.
    15. The patient reports current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists.
    16. The patient reports current or recent (within 1 week preceding screening) treatment with opioid agonists or partial agonists.
    17. The patient used/uses disallowed recent or concomitant medication (specified in Appendix II, Recent and Concomitant Medication) or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study.
    18. The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
    19. The patient is currently participating or has recently (4 weeks prior to 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.
    20. The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to screening.
    21. The patient is pregnant or breast-feeding.
    22. The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
    23. The patient is a member of the site personnel or their immediate families.
    24. The patient is under forced treatment.
    25. The patient has previously participated in clinical studies with nalmefene.
    E.5 End points
    E.5.1Primary end point(s)
    Safety will be evaluated by adverse events (AEs), clinical safety laboratory tests, vital signs, weight, electrocardiograms (ECGs), physical examinations and POMS scale.
    The therapeutic effect on the reduction of alcohol consumption will be evaluated on exploratory basis. It will be evaluated by number of HDD, total consumption, DrInC, CGI-I, CGI-S, GGT, ALAT, CDT and MCV.
    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 No
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA93
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Provided in the Protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months21
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months21
    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.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 485
    F.4.2.2In the whole clinical trial 668
    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)
    Provided in the Protocol
    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 Decision2009-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
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