Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-005801-20
    Sponsor's Protocol Code Number:2008_23/0832
    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:2009-03-19
    Trial results View 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 number2008-005801-20
    A.3Full title of the trial
    Etude d’efficacité et d’acceptabilité du méthylphénidate dans les troubles de la marche de la maladie de Parkinson : Etude multicentrique en double aveugle versus placebo.
    A.3.2Name or abbreviated title of the trial where available
    PARGKAIT II
    A.4.1Sponsor's protocol code number2008_23/0832
    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 Régional et Universitaire de Lille
    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 RoleComparator
    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 Méthylphenidate (Ritaline®)
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS Pharma S.A.S.
    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 nameMéthylpenidate
    D.3.4Pharmaceutical form Buccal tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNchlorydrate de méthylphénidate
    D.3.9.1CAS number 298-599
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    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 placeboBuccal tablet
    D.8.4Route of administration of the placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Troubles de la marche
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10056242
    E.1.2Term Parkinsonian gait
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objectif principal :
    Confirmer les résultats de l’étude préliminaire suggérant l’efficacité du methylphenidate sur les troubles de la marche de la maladie de Parkinson évaluée par le temps sur le Stand-Walk-Sit test au cours d’un test d’administration aigue de L-dopa avec une méthodologie rigoureuse d’étude comparative en groupe parallèle (méthylphenidate et placebo) en double aveugle versus placebo. L’ensemble des tests à la L-Dopa à l’inclusion et à la fin de l’étude de tous les patients de tous les centres sera enregistrés par vidéo afin centraliser l’évaluation en aveugle par deux neurologues.
    E.2.2Secondary objectives of the trial
    Objectifs secondaires :
    Efficacité sur le nombre de pas et de freezing au SWS test, évaluation clinique spécifique de la marche et des freezing (FOG trajectory) d’après Bloem, échelle objective d’Achiron, test RSGE, l’UPDRS I (nouvelle version), II, III et IV, l’échelle de dyskinésie (DRS), auto questionnaire de Giladi, échelle ABC (activity-specific Balance Confidence), agenda des freezing et des chutes, les échelle d’Epworth et de Parkinson’s Disease Sleep Scale, l’apathie (Lille Apathy Rating Scale) et la dépression (MADRS, BPRS); l’acceptabilité l’ECG, la tension artérielle, la biologie et la tolérance générale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Maladie de Parkinson (critères de Gibb)
    - Troubles de la marche sévère incluant une hypokinésie de la marche et des freezing.
    - La réponse à la 3ème question de l’auto questionnaire de Giladi doit être 2 ou 3 : Est-ce que vos troubles de la marche affectent votre vie quotidienne et votre indépendance ? Réponse : OUI Modérément à Sévèrement.
    - Le patient peut marcher avec peu (une canne) ou pas d’aide.
    - Score au MMSE ≥ 27 et Score de Mattis ≥ 130
    - Possibilité d’un traitement concomitant par stimulation à haute fréquence des noyaux sub-thalamiques depuis au moins un an.
    - Nécessité d’un aidant (conjoint, enfant, ami, aide à domicile) afin de contrôler le risque inhérent à ce psychotrope concernant l’éventualité d’une dépendance, d’un mésusage ou d’une surconsommation. Cette personne devra attester avoir pris connaissance des risques liés au traitement et accepte de prendre en charge la surveillance du patient par la signature du consentement préalablement signé par le patient.
    E.4Principal exclusion criteria
    - Sujet âgé de plus de 80 ans.
    - Sujet sans traitement par L-Dopa ou agoniste dopaminergique.
    - Adaptations de la dopathérapie ou des paramètres de stimulation au cours de l’étude.
    - Absence d’efficacité de la stimulation haute fréquence des noyaux sub-thalamiques ou implantation récente de moins d’un an.
    - Dyskinésies sévères. L’existence de quelques rares dyskinésies d’expression légère et non invalidante ne constitue pas un critère d’exclusion. Item 33 de l’échelle UPDRS IV ≥ 3.
    - Antécédent psychiatrique à l’aide de l’entretien psychiatrique semi structuré avec le MINI du DSM IV: maladie bipolaire, état psychotique, dépression sévère en cours, manifestations d’angoisse sévère. Une dysthymie et un antécédent isolé de dépression ne constituent pas un critère d’exclusion.
    - Antécédent de psychose associée à la maladie de Parkinson ou d’hallucinations même critiquées, manifestations psychotiques.
    - Patient ayant une démence parkinsonienne (critère DSM IV, Score au MMSE < 26 et Score de Mattis < 130)
    - Hyperthyroïdie
    - Arythmie cardiaque, affections cardiovasculaires sévères, angor sévère, infarctus du myocarde récent et affections cardiovasculaires sévères.
    - Tension artérielle grave non contrôlée.
    - Glaucome par fermeture de l’angle.
    - Antécédents personnels et/ou familiaux de tics moteurs et syndrome de Gilles de la Tourette.
    - Patient dénutri, cachectique.
    - Présence d’une autre pathologie grave.
    - Allaitement et grossesse.
    - Dépendances préexistantes aux médicaments, aux drogues ou à l’alcool,
    - Syndrome de dysrégulation dopaminergique avec des troubles sévère et évolutif de l’inhibition des compulsions.
    - Hypersensibilité au méthylphédinate ou à tout autre constituant du produit.
    - Incapacité de donner son consentement.
    - Présence d’un des traitements suivants qui ne peut être arrêté pendant une période correspondant à 5 demi-vies avant l’inclusion: IMAO sélectifs et non sélectifs (nialamide et iproniazide, sélégiline, vasoconstricteurs comme la phénylpropanolamine, la pseudoéphrédine, l’éphrédine, la phényléphrine), anesthésiques volatils halogénés, guanéthidine et apparentés,
    Traitement par sympathomimétiques alpha (voies orale et/ou nasale) (étilefrine, midodrine, naphazoline, oxymétazoline, tetryzoline, tuaminoheptane, tymazoline),
    Les opiacés et les dérivés morphiniques. Cf. Intéractions des RCP.
    Ces Traitements concomitants sont contre-indiqués à l’inclusion et durant toute la durée de l’étude :
    E.5 End points
    E.5.1Primary end point(s)
    Le temps sur l'échelle de Stand-Walk-Sit test (SWS) par chronométrage
    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 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) 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 concerned17
    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 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
    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
    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 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 Decision2009-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-31
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 07:15:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA