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    Summary
    EudraCT Number:2011-004142-17
    Sponsor's Protocol Code Number:17082011
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-02-24
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-004142-17
    A.3Full title of the trial
    High-dose baclofen for the treatment of alcohol addiction- A double-blind, randomized, placebo-controlled study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    High-dose baclofen for the treatment of alcohol addiction
    A.4.1Sponsor's protocol code number17082011
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAcademic Medical Centrum
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmsterdams Fonds voor Verslavingsonderzoek
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Amsterdam
    B.5.2Functional name of contact pointClinical Trials Information Baclofe
    B.5.3 Address:
    B.5.3.1Street AddressWeesperplein 4
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1018 XA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310205256871
    B.5.5Fax number00310206390279
    B.5.6E-mailE.M.BerahaMenahem@uva.nl
    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 Baclofen
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameBaclofen
    D.3.2Product code RVG 21993=12153
    D.3.4Pharmaceutical form 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 INNBACLOFEN
    D.3.9.1CAS number 1134-47-0
    D.3.9.3Other descriptive nameLioresal
    D.3.9.4EV Substance CodeSUB05667MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30 to 150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    E.1.1.1Medical condition in easily understood language
    Alcohol addiction
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary goal of the present study is to examine the efficacy of high dose baclofen for the treatment of patients with AD in a double-blind, randomized, placebo controlled study.
    E.2.2Secondary objectives of the trial
    Furthermore, as a secondary study objective, factors, which may predict the treatment response of baclofen are investigated. In order to assess which patients benefit the most of the treatment with baclofen, it is proposed to examine the role of:
    - anxiety
    - motives to drink
    - personality
    - family history and age of onset of AD
    - genetic endowments
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and Female patients, aged between 18-60 years
    - Participants have a current DSM-IV diagnosis of alcohol dependence
    - Participants sign a witnessed informed consent
    - Participants have a breath alcohol concentration lower than 0.05 at the screening visit
    - Participants must have been drinking ≥ 14 drinks (female) or ≥ 21 drinks (males) on average per week over a consecutive 30-day period in the 90-day period prior to the start of the study and have two or more days of heavy drinking (5 drinks for females, 6 drinks for males) in the 90-day period prior to the start of the study
    - Participants must have had a minimum of 96 hours of abstinence prior to the start of the study
    - Participants can be abstinent for a maximum of 21 days prior to the start of the study
    - Participants must be able to speak and understand dutch
    - Participants provide an identified locator person that can be contacted during the study in the event of loss of contact
    E.4Principal exclusion criteria
    - Participants with severe psychiatric disorders (schizophrenia, schizoaffective disorder, bulimia/anorexia, dementia, or ADHD requiring medication) except for depression, bipolar disorder and anxiety
    - Participants with serious medical illnesses (Parkinson’s disease, gastric ulcer, duodenal ulcer, cerebrovascular disease, respiratory insufficiency, hepatic or renal insufficiency, and epilepsy)
    - Participants who are at risk of suicide evaluated by the suicidality module of M.I.N.I.
    - Participants who have a cognitive impairment which is likely to interfere with the understanding of the study and its procedures - Participants with a diagnosis of dependence on any drugs except for nicotine, cannabis, alcohol and caffeine, if alcohol dependence doesn’t represent the main addiction
    - Participants who are/or could be pregnant or nursing infants
    - Participants who intend to engage in additional treatment for alcohol-related problems (except for self-help treatments which are not considered as formal treatment)
    - Participants with current or recent (3 month prior to the start of the study) treatment with anti-craving medication (acamprosate, naltrexone, disulfiram, or topiramate)
    - Participants who have had more than seven days of inpatient treatment for substance use disorder in the 30 days prior to the start of the study
    - Participants who have used baclofen in the last 30 days
    E.5 End points
    E.5.1Primary end point(s)
    Based on earlier literature it is expected that 70 % of patients treated with baclofen will achieve and maintain abstinence throughout the experimental period, compared to 20 % of the patients in the placebo condition.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 18 weeks
    E.5.2Secondary end point(s)
    It is expected that there will be a decrease of anxiety, caused by baclofen. Furthermore, a greater number of participants with coping motives will maintain abstinence compared to patients with enhancement motives. Furthermore, it is expected that particular genes predict treatment response.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 18 weeks
    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    End of the trial is when all participants successfully finished the three testing sessions. End of trial is when we can successfully determine the effects of baclofen in the treatment of alcohol addiction.
    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 months10
    E.8.9.1In the Member State concerned days17
    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: 250
    F.1.3Elderly (>=65 years) No
    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 state250
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 250
    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)
    Subject can choose to continue taking baclofen after the end of the trial. Baclofen is then prescribed by a physician. Furthermore, phone interviews will be held after 3, 6, and 9 month in order to assess use of alcohol and well being.
    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 Decision2012-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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