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    The EU Clinical Trials Register currently displays   42752   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-021265-80
    Sponsor's Protocol Code Number:PHRCNATHorsCancer2010-HC11-05
    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:2010-07-22
    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 number2010-021265-80
    A.3Full title of the trial
    Injections intradétrusoriennes de toxine botulique A chez l'enfant présentant un syndrome d'hyperactivité vésicale neurogène : essai thérapeutique contrôlé multicentrique de non infériorité entre deux doses rapportées au poids.
    A.3.2Name or abbreviated title of the trial where available
    TBIDE
    A.4.1Sponsor's protocol code numberPHRCNATHorsCancer2010-HC11-05
    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 SponsorCentre Hospitalier Universitaire de Reims
    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 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 Yes
    D.2.1.1.1Trade name DYSPORT 500 UNITES SPEYWOOD
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA
    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 Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 93384-43-1
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 93384-43-1
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Syndrome d'hyperactivité vésicale neurogène chez l'enfant
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10029279
    E.1.2Term Neurogenic bladder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Déterminer si une posologie à mi-dose de Toxine Botulique de type A permet d'escompter des résultats similaires à la posologie à pleine dose chez l'enfant présentant une hyperactivité détrusorienne symptomatique neurologique.
    E.2.2Secondary objectives of the trial
    * Analyser les critères urodynamiques, en particulier la compliance, des non répondeurs, ceci dans le but d'affiner les indications,
    * Homogénéiser les pratiques des différents opérateurs et déterminer des doses minimales efficaces,
    * Permettre une amélioration du rapport bénéfice/risque concernant un produit largement utilisé hors AMM dans cette indication,
    * Essayer de rapporter la posologie à une unité plus constante que le poids, comme par exemple la capacité vésicale, meilleur reflet de la surface détrusorienne et censée permettre une meilleure adaptabilité des doses
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1) Evaluation de la qualité de vie dans cette population de patients et de l'impact de ce type de traitement sur celle-ci (version 13 du 09/09/2010). Elle sera évaluée par le CHQ50, forme courte du CHQ, questionnaire de qualité de vie adapté à l'enfant et validé entre 5 et 18 ans.

    2) Etablir une étude coût/efficacité après élaboration d'une dose "idéale" (version 13 du 09/09/2010) : l'étude du surcoût comparé à la prise en charge standard avec traitement anticholinergique chez l'adulte montre un rapport coût/efficacité favorable en tenant compte d'un score mesurant le coût par unité de la qualité de vie gagnée. En fonction des résultats, un bilan financier sera réalisé pour établir les gains financiers liés à la demi-dose.
    E.3Principal inclusion criteria
    1) Enfants de 3 ans révolus à moins de 16 ans, affiliés à un régime de sécurité sociale et ayant signé le consentement,
    2) Souffrant d'une "vessie neurologique" : myélopathies (dysraphismes congénitaux, atteintes acquises), traumatisme crânien, IMC, SEP,
    3) Hyperactivité vésicale symptomatique, non ou mal contrôlée par un traitement anticholinergique, ou en cas de contre-indication ou d'intolérance au dit traitement, ou en cas de difficulté d'ingestion médicamenteuse : persistance d'une incontinence, manifestations d'hyper-reflexie autonome itératives, retentissement sur le haut appareil urinaire en raison de hautes presssions détrusoriennes,
    4) Hyperactivité détrusorienne définie au bilan urodynamique par l'existence de contractions détrusoriennes pendant la phase de remplissage de plus de 15 cm d'eau, ou par l'existence d'un arc réflexe mictionnel désinhibé,
    5) Vessie d'origine (native) et n'ayant jamais reçu de la Toxine Botulique,
    6) Pour les patients recevant de la TB pour une indication non urologique (e.g enfant traité pour une spasticité des muscles squelettique) : un délai de 3 mois entre l'injection musculaire périphérique et l'injection intra-vésicale sera obligatoire pour pouvoir être inclus,
    7) Les patients inclus sont en cathétérisme intermittent (CI) ou susceptible de l'être,
    8) L'injection sera réalisée à distance d'une éventuelle épine irritative (escarre ...)
    E.4Principal exclusion criteria
    1) Enfants de moins de 3 ans et de plus de 16 ans,
    2) Présentant une hyperactivité non neurologique,
    3) Bonne tolérance et efficacité du traitement anticholinergique,
    4) Vessie agrandie ou déjà traitée par une ou plusieurs injections de toxine,
    5) Enfants ayant bénéficié d'une injection de toxine dans un autre site depuis moins de 3 mois,
    6) Enfant chez qui le sondage n'est pas envisageable de façon satisfaisante,
    7) Contre-indication à l'utilisation de Toxine Botulique intra-détrusorienne (myasthénie, sclérose latérale amyotrophique, troubles de l'hémostase),
    8) Contre-indication à une anesthésie générale,
    9) Patients avec une infirmité motrice cérébrale souffrant de troubles majeurs de la coordination pharyngo-laryngée,
    10) Grossesse ou allaitement.
    E.5 End points
    E.5.1Primary end point(s)
    L'évaluation repose principalement sur les critères urodynamqiues, critères objectifs, et par ailleurs sur l'évaluation de la continence urinaire (analyse des "calendriers mictionnels" et calcul du score de continence (score de Baukloh)).
    L'évaluation est donc basée sur les variations des mesures urodynamiques et des scores de continence, pré et post-injection.
    L'échographie rénale et la mesure de la qualité de vie (CHQ50) sont utilisés pour les études ancillaires.
    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 Yes
    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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Mi-dose de Dysport 500 Unités Speywood
    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 concerned18
    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 Information not present in EudraCT
    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
    La fin de l'essai correspond à la 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 months0
    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 months0
    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 Yes
    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.1.1.6Adolescents (12-17 years) Yes
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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 Decision2010-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-30
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