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    Summary
    EudraCT Number:2012-004586-41
    Sponsor's Protocol Code Number:CHUBX2012/16
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2013-06-19
    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 number2012-004586-41
    A.3Full title of the trial
    Cognitive remediation in Attention Deficit Disorder with or without Hyperactivity (ADHD) children : Comparison between three therapeutic strategies : cognitive remediation with a virtual classroom software and methylphenidate and supportive psychotherapy
    Remédiation cognitive et Trouble Déficit de l’Attention avec ou sans Hyperactivité (TDAH) chez l’enfant : comparaison de trois prises en charge : Remédiation cognitive par un logiciel de classe virtuelle versus méthylphénidate ou psychothérapie de soutien.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cognitive remediation and Attention Deficit Disorder with or without Hyperactivity (ADHD)
    Remédiation Cognitive et Trouble Déficitaire de l'Attention avec ou sans Hyperactivité (TDAH)
    A.3.2Name or abbreviated title of the trial where available
    RECOGNITA
    RECOGNITA
    A.4.1Sponsor's protocol code numberCHUBX2012/16
    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 SponsorCHU de Bordeaux
    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 supportAssociation pour l'Amélioration des Conditions de Vie des Enfants et Adolescents Hospitalisés
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointStéphanie BIOULAC
    B.5.3 Address:
    B.5.3.1Street AddressCentre Jean Abadie Groupe Hospitalier Saint-André - 89 Rue des Sablières
    B.5.3.2Town/ cityBordeaux
    B.5.3.3Post code33077
    B.5.3.4CountryFrance
    B.5.4Telephone number05 56 78 47 41
    B.5.6E-mailstephaniebioulac@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 QUASYM L.P. 10 mg, gélule à libération modifiée QUASYM L.P. 20 mg, gélule à libération modifiée
    D.2.1.1.2Name of the Marketing Authorisation holderSHIRE PHARMACEUTICALS IRELAND LIMITED
    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.3.1Product nameQUASYM LP
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 Yes
    D.3.11.13.1Other medicinal product typeStupéfiant
    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
    Attention Deficit Disorder with or without Hyperactivity
    Trouble Déficit de l’Attention avec ou sans Hyperactivité
    E.1.1.1Medical condition in easily understood language
    Attention Deficit Disorder with or without Hyperactivity
    Trouble Déficit de l’Attention avec ou sans Hyperactivité
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level HLT
    E.1.2Classification code 10003730
    E.1.2Term Attention deficit and disruptive behaviour disorders
    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
    To examine whether a cognitive remediation program based on the virtual classroom software can be a therapeutic tool for children suffering from ADHD.
    Démontrer l’efficacité d’un outil de réalité virtuelle (classe virtuelle) en remédiation cognitive comme outil de prise en charge chez des enfants TDAH.
    E.2.2Secondary objectives of the trial
    Compare children's cognitive performances on the virtual classroom software, before, during and after treatments ( cognitive remediation program or supportive psychotherapy or drug treatment)
    Compare children's cognitive performances on neuropsychological tests before, during and after treatments ( cognitive remediation program or supportive psychotherapy or drug treatment)
    Comparer les performances cognitives à la classe virtuelle des enfants TDAH avant, durant (pour le groupe remédiation cognitive uniquement), et après la prise en charge.
    Comparer les performances cognitives aux tests neuropsychologiques des enfants TDAH avant et après prise en charge.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient, male or female, aged 7 to 11 years,
    - Responding to current diagnostic criteria for ADHD according to DSM IV-TR,
    - Presenting a total score on the ADHD-RS (ADHD Rating Scale)> 28 (before treatment),
    - Stopping his supportive psychotherapy if he had begun one,
    - Schooled in conventional class,
    - Presenting a WISC IV total score> 80 (done maximum one year before the inclusion or at the inclusion)
    - Registered to social security,
    - Informed consent given by the two holders of parental authority
    - Patient de sexe masculin ou féminin, âgé de 7 à 11 ans,
    - Répondant au critère diagnostic actuel du TDAH selon le DSM IV-TR,
    - Présentant un score total à l’ADHD-RS (ADHD Rating Scale) > 28,
    - Scolarisé en milieu classique,
    - Présentant un score total WISC IV > 80 (réalisé dans l’année précédant l’inclusion dans le cadre du suivi, sinon au moment de l’inclusion),
    - Devant arrêter la psychothérapie de soutien, s’il en suit une
    - Inscrit à la sécurité sociale,
    - Dont le consentement a été donné par les deux titulaires de l’autorité parentale
    E.4Principal exclusion criteria
    - Uncorrected perceptual disorder
    - Subjects with a pervasive developmental disorder, psychotic disorder, characterized major depressive disorder
    - Subjects who participated in research in the last 3 months
    - Subjects suffering from: glaucoma, hyperthyroidism, thyrotoxicosis, heart diseases (high blood pressure, congestive heart failure, etc…), cerebrovascular disorders.
    - Subjects with no deficit in the virtual classroom: having a total number of hit superior to 80 and a number of commissions inferior to 21
    For the group of children with ADHD treated with methylphenidate:
    - Patient stopping his treatment during the protocol
    For groups of ADHD children treated with cognitive remediation, and ADHD children treated with supportive psychotherapy:
    - Patients receiving treatment with psychostimulant during the protocol
    - Patient présentant un trouble de la perception non corrigé,
    - Patient présentant un TDAH uniquement de sous-type hyperactif
    - Patient sous psychostimulant,
    - Patient présentant un trouble envahissant du développement, un trouble psychotique, épisode dépressif majeur caractérisé actuel,
    - Patient souffrant d’une pathologie en contre-indication avec le traitement par méthylphénidate : glaucome, phéochromocytome, hyperthyroïdie, thyrotoxicose, troubles cardio-vasculaires (Hypertension artérielle, insuffisance cardiaque, etc…), troubles cérébrovasculaires, etc…
    - Patient ne présentant pas de déficit à la classe virtuelle : ayant un nombre de total de hit supérieur à 80 et un nombre de commissions inférieur à 21 (performances correspondant au quartile des meilleures performances à la classe virtuelle),
    - Patient ayant participé à une recherche dans les 3 derniers mois.
    - Dont le consentement ne peut pas être donné par l’un des deux titulaires de l’autorité parentale
    E.5 End points
    E.5.1Primary end point(s)
    Score at ADHD Rating Scale
    Score à l’ADHD Rating Scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day one and day 70 (before and after treatment)
    Jour 1 et jour 70 (avant et après traitement)
    E.5.2Secondary end point(s)
    Cognitives performances in neuropsychological tests assessing executive and attentional abilities
    Performances cognitives aux tests neuropsychologiques
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day one and day 70 (before and after treatment)
    Jour 1 et jour 70 (avant et après traitement)
    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 No
    E.6.5Efficacy No
    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 Yes
    E.8.1.3Single blind No
    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
    Prise en charge non médicamenteuse : Remédiation cognitive et psychothérapie de soutien
    Prise en charge non médicamenteuse : Remédiation cognitive et psychothérapie de soutien
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    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 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
    Last visit of the last subject
    Dernière visite du dernier patient
    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 months25
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months25
    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: 60
    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: 60
    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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    At the end of its participation in the research, the choice of the best care will be made for the patient. The investigator will judge if the treatment must be continued or not for his care.
    It is indispensable to watch attentively the patient after he stop his treatment by méthylphénidate, because a depression or a chronic hyperactivity can be then revealed. An extanded follow-up can could than be necessary, because of a risk of appearance of a severe depression
    A l’issue de sa participation à la recherche le choix de la meilleure prise en charge sera faite pour le patient.
    L’investigateur jugera de la nécessité ou non de la poursuite du traitement dans le cadre du soin courant.
    Il est indispensable de surveiller attentivement le patient à l' arrêt du traitement, car une dépression ou une hyperactivité chronique peuvent être révélées. Un suivi prolongé pourra donc s'avérer nécessaire en raison d’un risque d’apparition d’une dépression sévère.
    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 Decision2012-12-21
    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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