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    Summary
    EudraCT Number:2016-000106-11
    Sponsor's Protocol Code Number:I14039
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-000106-11
    A.3Full title of the trial
    EVALUATION OF THE EFFICIENCY OF TREATMENT BY BUMETANIDE ON AUTISTIC CHILDREN WITH A KNOWN ETIOLOGY: MULTICENTER AND DOUBLE-BLIND STUDY WITH RANDOMIZED PARALLEL GROUP, AGAINST PLACEBO.
    Evaluation de l'efficacité d'un traitement par bumétanide chez les enfants autistes avec une étiologie connue : étude multicentrique randomisée en groupes parallèles et double aveugle contre placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EVALUATION OF THE EFFICIENCY OF TREATMENT BY BUMETANIDE ON AUTISTIC CHILDREN WITH A KNOWN ETIOLOGY: MULTICENTER AND DOUBLE-BLIND STUDY WITH RANDOMIZED PARALLEL GROUP, AGAINST PLACEBO.
    Evaluation de l'efficacité d'un traitement par bumétanide chez les enfants autistes avec une étiologie connue : étude multicentrique randomisée en groupes parallèles et double aveugle contre placebo.
    A.3.2Name or abbreviated title of the trial where available
    BUMAUTEP
    BUMAUTEP
    A.4.1Sponsor's protocol code numberI14039
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/110/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLimoges Hospital
    B.1.3.4CountryFrance
    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 supportPHRC National
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLimoges Hospital
    B.5.2Functional name of contact pointDirector of Research
    B.5.3 Address:
    B.5.3.1Street Address02 avenue Martin Luther King
    B.5.3.2Town/ cityLimoges
    B.5.3.3Post code87 042
    B.5.3.4CountryFrance
    B.5.4Telephone number+33555058008
    B.5.5Fax number+33555056696
    B.5.6E-maildrc@chu-limoges.fr
    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 BURINEX 1mg, tablet
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire LEO
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Syrup
    D.3.4.1Specific paediatric formulation Yes
    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 INNBUMETANIDE
    D.3.9.3Other descriptive nameBUMETANIDE
    D.3.9.4EV Substance CodeSUB05971MIG
    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 placeboSyrup
    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
    autism
    autisme
    E.1.1.1Medical condition in easily understood language
    autism
    autisme
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10003805
    E.1.2Term Autism
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effectiveness of bumetanide treatment on the intensity of young autistic disorders with known etiology, as measured by changes in the score CARS (Childhood Autism Rating Scale) between D0 (inclusion) and D99 (after 3 first months of treatment).
    Evaluer l’efficacité d’un traitement par bumétanide sur l’intensité des troubles de jeunes autistes avec une étiologie connue, mesurée par l’évolution du score du CARS (Childhood Autism Rating Scale ou échelle d'évaluation de l'autisme infantile) entre J0 (inclusion) et J99 (après les 3 premiers mois de traitement).
    E.2.2Secondary objectives of the trial
    - Describe the evolution of the CARS score between 0 and D99, D99 and D190 (3 months + 3 months) in the etiology of autism.
    - Determine the safety profile of the experimental treatment
    - Décrire l’évolution du score de CARS entre J0 et J99, J99 et J190 (3 mois + 3 mois) selon l’étiologie de l’autisme.
    - Déterminer le profil de sécurité du traitement expérimental
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Children and teenager from age 5 to age 17, with a diagnosis of typical autism or Asperger syndrome according to the criteria of diagnosis of the WHO’s classification (CIM-10),
    - With a known etiology,
    - Of whom the parents have given their free, informed and written consent,
    - Affiliated or beneficiary of the French social security.
    NB:
    Patient taking melatonin and stabilized are eligible to the trial,
    Patient with a stabilized epilepsy by treatment (no comitial crisis for the 6 months before entering the trial) are eligible to the trial,
    - Enfants et adolescents âgés de 5 à 17 ans, répondant au diagnostic d’autisme typique ou du syndrome d’Asperger selon les critères diagnostiques d’autisme de la classification de l’OMS (CIM-10),
    - Patients ayant une étiologie connue,
    - Patients dont les titulaires de l’autorité parentale ont donné un consentement libre, éclairé et écrit,
    - Affilié ou bénéficiaire d’un régime de sécurité sociale française.
    NB :
    - Les patients sous mélatonine stabilisés sont éligibles à la participation à l’étude,
    - Les patients ayant une épilepsie équilibrée par un traitement (absence de crise comitiale dans les 6 mois précédents) sont éligibles à la participation à l’étude,
    E.4Principal exclusion criteria
    -Patients under treatment by inlet diuretic either at the time of the study or before,
    -Patients with electrolytic disorders,
    -Patients with a known hypersensitivity to sulfa drugs,
    -Patients with a hepatic or renal failure,
    -Patients for whom the CARS results are strictly inferior to 30,
    -Patients with an epilepsy not controlled by a treatment (comitial crisis in the past 6 month at the time the trial starts despite a treatment),
    -Patients under treatment by psychotropic exception made of the melatonin,
    -Allergy to the bumetanide or one of its excipients,
    -Patient under a treatment by lithium, diphémanil, érythromycine IV, halofantrine, pentamidine, sultopride,
    -pregnant and lactating women.

    Secondary exclusion criteria:
    - QT prolongation noticed on the ECG at Day0,
    - Anomaly on the biological check up (Day 0) made before including the patient that would contraindicated the prescription of bumétanide,
    - Patients for whom the CARS results are strictly inferior to 30.
    - Patients bénéficiant ou ayant bénéficié d’un traitement par diurétique de l’anse,
    - Patients présentant des désordres électrolytiques,
    - Patients présentant une hypersensibilité connue aux sulfamides,
    - Patients présentant une insuffisance hépatique ou rénale,
    - Patients dont la CARS est strictement inférieure à 30,
    - Patients présentant une épilepsie non équilibrée par un traitement (présence de crise comitiale dans les 6 mois précédents malgré un traitement adapté),
    - Patients recevant un traitement psychotrope à l’exception de la mélatonine,
    - Allergie connue au bumétanide ou ses excipients,
    - Patient sous lithium, diphémanil, érythromycine IV, halofantrine, pentamidine, sultopride, vincamine,
    - Patiente enceinte ou allaitante.

    Critères d'exclusion secondaire:
    -Allongement QT sur l’ECG réalisé à J0.
    -Anomalie au bilan biologique de l’inclusion (J0), contre-indiquant la prescription de Bumétanide
    -Patients dont la CARS est strictement inférieure à 30
    E.5 End points
    E.5.1Primary end point(s)
    The evolution of the result of the CARS (evaluation scale of the intensity of autism in child autism) between day 0 and day 99.
    Différence d’évolution du score CARS (échelle d’évaluation de l’intensité de l’autisme infantile) entre J0 et J99 entre les deux groupes de randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 days
    2 jours
    E.5.2Secondary end point(s)
    1) CARS between D0 and D99 and between D99 and D190 which will be describe by etiology.
    2) Analysis of adverse events which happened during the study (comparison of the two groups between D0 and D99, and analysis of the adverse events that occurred with subjects taking the Bumetanide between D0 and D190).
    The adverse events will be of a clinical and biological nature.
    1.Comparaison de l’évolution du score de CARS entre J0 et J99, et J99 et J190 pour chaque sous-groupe d’étiologie de l’autisme.
    2.Analyse des évènements indésirables (EI) survenus au cours de l’étude (comparaison entre les 2 bras entre J0 et J99, et analyse des évènements indésirables survenus sous Bumétanide entre J0 et J190). Les EI considérés seront de nature clinique et biologique.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 days
    3 jours
    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 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.8.2.4Number 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
    LVLS
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 Yes
    F.1.1Number of subjects for this age range: 88
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 44
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 44
    F.1.2Adults (18-64 years) No
    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 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 state88
    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 Decision2016-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-20
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