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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-016143-19
    Sponsor's Protocol Code Number:09 196 07
    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:2010-02-22
    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 number2009-016143-19
    A.3Full title of the trial
    VALIDATION OF DYSKINESIA RATING SCALES
    A.4.1Sponsor's protocol code number09 196 07
    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 SponsorMichael J. Fox Foundation for Parkinson’s Research
    B.1.3.4CountryUnited States
    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 MANTADIX
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB
    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 nameAmantadine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Maladie de parkinson
    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
    - Déterminer la sensibilité de plusieurs échelles évaluant les dyskinésies et identifier la (ou les) meilleure (s) échelle(s) permettant de détecter les modifications des dyskinésies induites par l’Amantadine
    E.2.2Secondary objectives of the trial
    Quantifier l’effet anti dyskinétique de l’Amantadine et déterminer un seuil thérapeutique minimum à atteindre pour démontrer l’effet antidyskinétique des molécules en développement dans le traitement des dyskinésies induites par la L Dopa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Malades des 2 sexes, âgés de 30 à 90 ans et atteints d’une maladie de Parkinson idiopathique répondant aux critères de définition de la UKPDS Brain Bank (Gibb and Lees, 1988) - Présentant des dyskinésies de pic de dose induites par la L-dopa, définies par un score CGI ≥ 3, établi par l’évaluation globale du clinicien - ne recevant pas un traitement par Amantadine depuis au moins 3mois -Recevant un traitement antiparkinsonien stable depuis au moins 4 semaines et chez qui l’on présume qu’il sera possible de maintenir ce traitement inchangé pendant la durée de l’étude- ayant un accompagnant souhaitant participer à l’étude- ayant montré sa capacité à remplir un journal de bord précis après un entrainement durant la période de screening- Ayant donné son consentement libre et éclairé et signé le consentement- Etant affilié à un régime de sécurité sociale
    E.4Principal exclusion criteria
    Patient présentant un syndrome parkinsonien non idiopathique atypique (de type Paralysie SupraNucléaire (PSP), Atrophie Multi systématisée (MSA), Dégénérescence Cortico Basale (DCB), etc…)- Patients présentant un syndrome parkinsonien induit par un médicament-Patients ayant présenté des effets indésirables sous Amantadine et ayant dû l’interrompre- Patient atteint d’une démence, de troubles psychiatriques sévères (dépression ou psychose)- Patient incapable de comprendre le protocole, de remplir un carnet de bord ou un autre critère de jugement ou de suivre les procédures de l’essai clinique- Patients présentant une contre-indications à l’Amantadine (RCP Vidal 2006: hypersensibilité connue aux médicaments de la classe de l’Amantadine ou l’un des constituant, association avec les neuroleptiques anti-émétiques, patient présentant des antécédents d’épilepsie, d’état confusionnel, d’hallucinations ou ayant fait un état psychonévrotique grave non contrôlé par un traitement, patients ayant des antécédents d’insuffisance cardiaque congestive ou d’œdème périphérique, patients ayant des antécédents d’eczéma cutané)-Insuffisant rénal (créatininémie > 150 µmol/l)-femme enceinte ou allaitante ou en âge de procréer sans dispositif contraceptif efficace-Patient ayant bénéficié d’une intervention par chirurgie fonctionnelle pour maladie de Parkinson-Patient sous tutelle, curatelle ou sauvegarde de justice.
    E.5 End points
    E.5.1Primary end point(s)
    Comparaison des modifications des échelles de dyskinésies après 8 semaines de traitement dans 2 groupes de patients : patients traités par Amantadine versus patients sous placebo:- AIMS (abnormal Involuntary Movement Scale): distribution anatomique des dyskinésies et intensités- RDRS (Rush Dyskinesia Rating Scale) : retentissement fonctionnel durant les activités de la vie quotidienne- LFS (Lang-Fahn Activities of Daily Living Dyskinesia Scale) : ressenti du patient- UPDRS (United Parkinson’s Disease Rating Scale) partie IV item 32,33,34,35 : information sur la durée des dyskinésies et leur retentissement au cours de la dernière semaine-MDS UPDRS part IV item 1,2,6: information sur la durée des dyskinésies et leur retentissement au cours de la dernière semaine- Obeso Dyskinesia Scale : échelle généraliste sur les dyskinésies- UDysRS (Unified Dyskinesia Rating Scale) [objective (Parts 3-4), subjective (Parts 1-2)] -carnet de bord rempli par le patient évaluant son état moteur toutes les demi heures.-PDYS-26 (Parkinson Disease Dyskinesia Scale) : autoquestonnaire évaluant les dyskinésies- Clinical Global Impressions – Severity (CGI-S) : évaluation subjective du patient- Clinical Global Impression – Change (CGI-C) : évaluation subjective du patient- Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) : evaluation motrice du patient parkinsonien
    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 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 Yes
    E.6.13.1Other scope of the trial description
    VALIDATION D4UNE ECHELLE
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 66
    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 Decision2010-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-18
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