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    Summary
    EudraCT Number:2014-000420-15
    Sponsor's Protocol Code Number:AKF1919
    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:2015-10-05
    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 number2014-000420-15
    A.3Full title of the trial
    Slow continuous subcutaneous flumazenil infusion for benzodiazepine dependence: a pilot study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Detoxification of high dose Benzo with flumazenil infusion
    Ontgifting van hoge dosis Benzo's door middel van een infuus met flumazenil
    A.4.1Sponsor's protocol code numberAKF1919
    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 SponsorRadboud University Medical Centre, department of Psychiatry
    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 supportRadboud University Medical Centre, department of Psychiatry
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNijmegen Institute for Scientist Practitioners in Addiction (NISPA)
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNovadic-Kentron Addiction Care network
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadoud University Medical centre department of psychiatry
    B.5.2Functional name of contact pointErik Paling
    B.5.3 Address:
    B.5.3.1Street Addresshuispost 963 Postbus 9101
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6500 HB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031613038350
    B.5.6E-mailerikpaling@hotmail.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 Anexate
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Nederland B.V.
    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 nameAnexate
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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
    Patients diagnosed with benzodiazepine dependence with an average daily dose of at least 30 mg of diazepam equivalence.
    E.1.1.1Medical condition in easily understood language
    Patients with high dose benzodiazepine dependence who cannot succeed in detoxification otherwise
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10004099
    E.1.2Term Barbiturate and similarly acting sedative or hypnotic dependence, continuous use
    E.1.2System Organ Class 100000004873
    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 objective is to demonstrate that detoxification of benzodiazepines in high-dose benzodiazepine dependent patients using continuous subcutaneous infusion of flumazenil is feasible and safe.
    E.2.2Secondary objectives of the trial
    Secondary goals of the study are to explore
    1) the effect of flumazenil detoxification on anxiety levels during and after detoxification,
    2) the effects of flumazenil detoxification on sleep quality during and after detoxification,
    3) patient satisfaction with flumazenil detoxification,
    4) efficacy of flumazenil detoxification.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • A primary diagnosis of benzodiazepine dependence with an average daily dose of at least 30 mg of diazepam or equivalent according table 2
    OR
    A diagnosis of benzodiazepine dependence with an average daily dose of at least 30 mg of diazepam or an equivalent with a co-morbid diagnosis of alcohol or cannabis dependence. Prior to the baseline measurement and flumazenil infusion patients must be abstinent from alcohol and cannabis for at least two months.
    • Age between 21 and 65 years.
    • Participants should master Dutch language sufficiently to provide informed consent and participate in all measurements (including self report questionnaires).
    • Motivation for and availability of a regular treatment after the detoxification procedure at a regional (addiction) care facility.
    E.4Principal exclusion criteria
    • History of epilepsy or IEDs on EEG or other serious neurological disorders;
    • History of a serious medical condition, including heart disease (myocardial infarction or arrhythmias), lung disease (COPD gold stage II or higher), acute liver or kidney disease (indexed by ASAT ALAT max three times the norm or increased Creatinine/Ureum);
    • Diagnosis of a current severe psychiatric disorder (psychosis, mania, severe depression);
    • Diagnosis of a primary organic sleep disorders e.g. hypersomnia, disorders of the sleep wake schedule and sleep apnoea;
    • A positive urine screening for cocaine, heroin, amphetamine, ecstasy, cannabis, opiates, buprenorphine and methadone;
    E.5 End points
    E.5.1Primary end point(s)
    Only mild and transient withdrawal symptoms during and after detoxification,
    Without the occurrence of any adverse events.
    Without IEDs on EEG/PSG recording.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during detoxification an after one month and three month.
    E.5.2Secondary end point(s)
    After detoxification
    1) Decreased anxiety levels,
    2) Improve sleep quality,
    3) A satisfactory method for detoxification reviewing the detoxified patients,
    4) Show 100% completers, 75% abstinence after 3-months and improved quality of life.
    E.5.2.1Timepoint(s) of evaluation of this end point
    during detoxification and after one and three month.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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: 30
    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 Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    None
    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 Decision2015-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-24
    P. End of Trial
    P.End of Trial StatusOngoing
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