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    Summary
    EudraCT Number:2009-015837-55
    Sponsor's Protocol Code Number:RAA09-004
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-015837-55
    A.3Full title of the trial
    Double-blind, 36 month, placebo-controlled trial of mifepristone on cognition in alcoholics
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cortisol and Memory in Alcoholics
    A.3.2Name or abbreviated title of the trial where available
    Cortisol and Memory in Alcoholics
    A.4.1Sponsor's protocol code numberRAA09-004
    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 SponsorKings College London
    B.1.3.4CountryUnited Kingdom
    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 supportMedical Research Council
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitute of Psychiatry, King's College London
    B.5.2Functional name of contact pointProfessor Colin Drummond
    B.5.3 Address:
    B.5.3.1Street AddressAddictions Department, Institute of Psychiatry, King's College London, 4 Windor Walk
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00442078480817
    B.5.5Fax number00442078480839
    B.5.6E-mailcolin.drummond@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorSouth London and Maudsley NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportMedical Research Council
    B.4.2CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name Mifegyne
    D.2.1.1.2Name of the Marketing Authorisation holderExelgyn Laboratories
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMifepristone
    D.3.4Pharmaceutical form 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 INNMIFEPRISTONE
    D.3.9.1CAS number 84371653
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Alcoholism
    E.1.1.1Medical condition in easily understood language
    Alcoholism
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10001639
    E.1.2Term Alcoholism
    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
    Does the action of the drug, mifepristone, in preventing the effects of the naturally released glucocorticoid hormone cortisol on the Type II glucocorticoid receptor reduce the cognitive deficits and/or the depression experienced by alcoholics?
    E.2.2Secondary objectives of the trial
    Does the drug, mifepristone, reduce the amount or frequency of relapse drinking in abstinent alcoholics?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (i) diagnosis of alcohol dependence by DSM-IV for 5 years or more
    (ii) male
    (iii) aged between 18 and 60 years (inclusive)
    (iv) willingness to provide informed consent

    E.4Principal exclusion criteria
    Exclusion criteria will be
    (i) clinical diagnosis of a neuroendocrine disorder,
    (ii) liver damage, determined by alanine aminotransferase (ALT) activity of more than 2.5 x normal range,
    (iii) renal dysfunction, as determined by creatinine levels over 150 umol/L in plasma samples taken prior to admission to the Alcohol Unit
    (iv) documented evidence of a psychotic disorder
    (v) severe brain damage or severe mental impairment,
    (vi) diagnosis of severe physical illness that would preclude participation (e.g. terminal illness),
    (vii) documented evidence of current dependence on a substance other than alcohol or nicotine
    (viii) inability to understand sufficient english to understand the information needed for the cognitive testing
    (ix) female gender
    (x) patients with Korsakoff's/Wernicke's syndromes (less than 2% in our Treatment Unit) will not be included because the cognitive deficits are considered to be permanent and due primarily to thiamine deficiency
    (xi) porphyria
    (xii) severe asthma uncontrolled by therapy
    (xiii) cardiac disorders i.e. myocardial infarction, congestive cardiac failure or cardiomyopathy
    (xvi) Has persistent high blood pressure (over 160 mmHg systolic and/or 100 mmHG diastolic on both of two readings at initial screening session)
    (xv) medical history of diabetes
    (xvi) known allergy to mifepristone
    (xvii) owing to potential interactions with mifepristone, participants taking the following drugs will be excluded: ketoconazole, itraconazole, metronodazole, miconazole, erythromycin, clarithromycin, rifampin, rifabutin, norfloxacin, nelfinavir, ritonavir, saquinavir, zafirlukast, fluvoxamine, quinine, phenytoin, phenobarbital, primadone, carbamazepine, amiodarone, warfarin, corticosteroids or St John's Wort. Consumption of grapefruit juice is also contraindicated during mifepristone treatment
    E.5 End points
    E.5.1Primary end point(s)
    Cognitive ability as measured by the CANTAB test battery
    Depressive symptoms, as measured by the Beck depression scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    CANTAB - Days 13 and 20 inclusive and between Days 21 and 28 inclusive
    Beck Depression Inventory (BDI-II) will record depressive symptoms every 7 days (± 2 days) for four weeks, starting one week after detoxification. The BDI-II will also be administered in Week 3, 4 and at the 3, 6 and 12 month follow up appointments.
    E.5.2Secondary end point(s)
    severity of the acute phase of alcohol withdrawal, alcohol craving and symptoms of protracted withdrawal including sleep disturbances
    E.5.2.1Timepoint(s) of evaluation of this end point
    The analysis on the data from the follow-up studies will be carried out when all the data from these have been collected, or in the case of difficulties in contacting for follow-up interviews, when the 12 month interval has passed for the last participant
    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 No
    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 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 trial2
    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 concerned5
    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 Yes
    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 trial will be closed when all participants have made their final follow-up visit, the data have been entered into the database, all queries have been resolved and the database has been locked.

    This definition allows time following the last visit of the last participant, to ensure that all data are thoroughly scrutinised and cleaned before being analysed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days14
    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: 52
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state52
    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)
    Mifepristone is hypothesised to be useful only in the acute phase of alcohol withdrawal, therefore there will be no continued intervention at the end of the trial. All participants will receive the standard care provided by the participating alcohol treatment services.
    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 Decision2010-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-24
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