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    The EU Clinical Trials Register currently displays   35419   clinical trials with a EudraCT protocol, of which   5814   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-020810-27
    Sponsor's Protocol Code Number:IB-08-03
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2010-08-13
    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 number2010-020810-27
    A.3Full title of the trial
    Essai clinique contrôlé randomisé, multicentrique, évaluant l'efficacité de deux médicaments homéopathiques (Dopamine 5 CH et Serotoninum muriaticum 5 CH) chez l'enfant TDAH âgé de 3 à 7 ans (6 ans et 11 mois).
    A.3.2Name or abbreviated title of the trial where available
    HYP-HOPE
    A.4.1Sponsor's protocol code numberIB-08-03
    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 SponsorLaboratoires BOIRON
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 No
    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 nameDopamine 5 CH
    D.3.2Product code NA
    D.3.4Pharmaceutical form Granules
    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 INNDopamine 5 CH
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 to CH
    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) 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 Yes
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 No
    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 nameSerotonium muriaticum 5 CH
    D.3.2Product code NA
    D.3.4Pharmaceutical form Granules
    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 INNSerotonium muriaticum 5 CH
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 to CH
    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) 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 Yes
    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 placeboGranules
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGranules
    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
    TDAH (Trouble Déficit de l'Attention Hyperactivité)
    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
    L’objectif principal de l’étude est d’évaluer l’efficacité de la combinaison Dopamine 5 CH et Serotoninum muriaticum 5 CH, administrée pendant 90 jours, chez l’enfant âgé de 3 à moins de 7 ans (le jour de l’inclusion) pour lequel un TDAH a été diagnostiqué.
    E.2.2Secondary objectives of the trial
    - Evaluer l’efficacité de la combinaison Dopamine 5 CH et Serotoninum muriaticum 5 CH administrée pendant 30 jours sur le TDAH chez l’enfant âgé de 3 à moins de 7 ans (le jour de l’inclusion).
    - Evaluer l’amélioration du TDAH de l’enfant selon le jugement de l’investigateur
    - Evaluer l'évolution de la qualité du sommeil de l’enfant
    - Evaluer la tolérance au traitement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Sexe masculin ou féminin,
     Agé, au jour de l’inclusion dans l’étude, d’au moins 3 ans et de moins de 7 ans 56 ans et 11 mois),
     Ne recevant pas de traitement psychostimulant ou psychotrope au jour de l'inclusion, ni dans les 3 mois précédant l'inclusion,
     Présentant un diagnostic de TDAH établi par un pédopsychiatre sur la base des critères du DSM-IV-R, validé un à un lors de visite d’inclusion
     Score T>65 à l’Index global de Conners destiné aux parents (Conners Global Index ou CGI-P)
     Parent(s) ou titulaire(s) de l’exercice de l’autorité parentale comprenant et lisant le français,
    Consentement écrit des titulaires de l’exercice de l’autorité parentale (ou du seul titulaire du plein exercice de l'autorité parentale),
     Parent(s) ou titulaire(s) de l’exercice de l’autorité parentale affilié(s) à un régime de Sécurité Sociale
    E.4Principal exclusion criteria
     Retard mental,
     Troubles envahissants du développement dont autisme,
     Troubles de l’humeur caractérisés,
     Déficit sensoriel important,
     Recevant ou susceptible de recevoir au cours de l’essai des traitements non autorisés par le protocole (psychotropes, dont le méthylphénidate (MPH) et autres psychostimulants, autre traitement homéopathique pour le TDAH),
     Maladie chronique évolutive concomitante (ex : épilepsie, maladie neurologique ou hormonale, asthme sous corticothérapie au long court),
     Parent(s) ou titulaire(s) de l’exercice de l’autorité parentale dans l’incapacité de comprendre et de suivre les exigences de l'étude, ne pouvant se soumettre aux contraintes du protocole (ex : non coopérants, incapables de se rendre aux visites imposées par le protocole) et probablement incapables de finir l’essai,
     Ayant participé à un essai clinique dans le mois précédant l’étude,
     Etant proche d’un investigateur directement impliqués dans l’essai,
     Déjà inclus dans l’essai.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère d’évaluation principal sera le pourcentage des enfants répondeurs au traitement Dopamine 5 CH et Serotoninum muriaticum 5 CH à J90±5. La réponse au traitement est définie par une baisse d’au moins 10 points du score de l’index global de après la prise du traitement.
    L’index global de Conners pour les parents (Conners Global Index-Parent – CGI-P) est le résultat d’une évaluation basée sur 10 items (4, 7, 11, 13, 14, 25, 31, 33, 37 et 38) de l’échelle de Conners CPRS-R version longue. Chaque appréciation est cotée de 0 (pas du tout) à 3 (énormément).
    Les scores obtenus pour les différents domaines évalués par le questionnaire sont convertis en scores normalisés ou scores T. La moyenne de ces scores est de 50 avec un écart standard de 10.
    En règle générale, les scores T au-dessus de 60 sont préoccupants et ont valeur d'interprétation. Les scores interprétables varient d'un faible score T de 61 (le moins atypique) à plus de 70 (nettement atypique). Ce type de score normalisé met en évidence ce qui est typique ou atypique selon l’âge et le sexe de l’enfant.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) No
    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 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.8.3 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 concerned30
    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
    Un comité indépendant de surveillance n'a pas été prévu spécifiquement pour cet essai compte-tenu du peu de risques en terme de tolérance, toutefois le comité scientifique de cet essai ainsi que le comité de rédaction du protocole suivront l'essai de manière très régulière et seront consultès dès qu'il en sera jugé nécessaire.
    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 months10
    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.1.1.1In 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) No
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state112
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 112
    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 Decision2010-10-06
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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