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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-005201-75
    Sponsor's Protocol Code Number:1125301
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-01-24
    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 number2011-005201-75
    A.3Full title of the trial
    Impact d’un traitement PREcoce par aMANtadine sur les DYSKinésies induites par la L-DOPA dans la maladie de Parkinson : étude comparative avec tirage au sort versus placebo.
    A.3.2Name or abbreviated title of the trial where available
    PREMANDYSK
    A.4.1Sponsor's protocol code number1125301
    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 Toulouse
    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 Programme Hospitalier de Recherche Clinique, Enveloppe Nationale 2011
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Toulouse
    B.5.2Functional name of contact pointElodie Lestimé
    B.5.3 Address:
    B.5.3.1Street AddressDRCI, Hôtel-Dieu, 2 rue Viguerie
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post code31059
    B.5.3.4CountryFrance
    B.5.4Telephone number3305 61 77 72 01
    B.5.6E-maillestime.e@chu-toulouse.fr
    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.2.1.1.1Trade 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 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 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 placeboCapsule
    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
    E.1.1.1Medical condition in easily understood language
    Maladie de Parkinson
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Démontrer que l’introduction d’un traitement par amantadine (200 mg/j) dès les premières années de prise en charge thérapeutique, c'est-à-dire chez des Parkinsoniens en « lune de miel » de la dopathérapie (phase précoce de la maladie, < 3 ans du diagnostic, < 1 an de L-Dopa et absence de complications de la dopathérapie), diminue le taux de sujets souffrant des mouvements anormaux involontaires dyskinétiques après 18 mois de suivi.
    E.2.2Secondary objectives of the trial
    - Déterminer si cet effet de l’amantadine sur les dyskinésies résulte d’un mécanisme à long-terme de type « disease modification » ou met simplement en jeu l’effet symptomatique antidyskinétique à court terme déjà documenté à un stade tardif de la maladie.

    - Déterminer si l’introduction d’un traitement par amantadine (200 mg/j) à ce stade de début de la maladie, c'est-à-dire chez des Parkinsoniens en lune de miel de la dopathérapie, diminue le taux de sujets souffrant d’autres complications potentielles de la dopathérapie telles que les fluctuations motrices ou non motrices après 18 mois de suivi.

    - Déterminer si l’introduction d’un traitement par amantadine (200 mg/j) à ce stade de la maladie, c'est-à-dire chez des Parkinsoniens en lune de miel de la dopathérapie, retarde la survenue de dyskinésies.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    cette étude ancillaire consistera en une étude pharmacogénétique pour identifier d’éventuels facteurs de susceptibilité génétique à l’apparition des dyskinésies
    E.3Principal inclusion criteria
    - Homme ou Femme, entre 35 ans et 80 ans
    - Ayant donné son consentement libre et éclairé et signé le consentement
    - Etant affilié à un régime de sécurité sociale
    - Malades atteints d’une maladie de Parkinson idiopathique répondant aux critères de définition de l’UKPDS Brain Bank
    - Maladie de Parkinson évoluant < 3 ans
    - Patient recevant un traitement par L-DOPA depuis < 1an
    - Patient ne présentant pas de complications de la dopathérapie
    Recevant un traitement antiparkinsonien stable pouvant associer, en plus de la L-DOPA, un agoniste dopaminergique, un IMAO-B, un anti-cholinergique depuis au moins 2 mois avant l’inclusion et chez qui l’on présume qu’il sera possible de maintenir ce traitement inchangé pendant la durée de l’étude (hormis la dose de L-dopa qui pourra être ajustée pendant l’étude après le 3ème mois de la Phase 1).
    E.4Principal exclusion criteria
    - Syndromes parkinsoniens atypiques et d’origine médicamenteuse
    - Forme juvénile de Parkinson
    - Patients présentant des complications de la dopathérapie
    - Traitement préalable par amantadine (de plus de 3 mois)
    - Contre-indications de l’amantadine
    - Impossibilité de maintenir le traitement antiparkinsonien en cours stable durant la durée de l’étude, en dehors de la L-DOPA.
    - Traitement neuroleptique
    - Patient présentant une démence, MMSE < 26
    - Patient présentant un trouble du comportement, item ECMP ≥ 3
    - Femme enceinte ou allaitante ou en âge de procréer sans dispositif contraceptif efficace
    - Patient sous tutelle, curatelle ou sauvegarde de justice
    E.5 End points
    E.5.1Primary end point(s)
    Taux de patients présentant des mouvements anormaux involontaires dyskinétiques (tels que définis spécifiquement dans le protocole) à l’issue des 18 mois de la phase 1 de l’étude (amantadine versus placebo).
    E.5.2Secondary end point(s)
    - Taux de patients présentant des mouvements anormaux involontaires dyskinétiques à l’issue de la phase 3 de l’étude (wash-out).
    - Taux de patients présentant des fluctuations motrices au bout de 18 mois de la phase 1 de l’étude (amantadine versus placebo) (définies à l’aide de l’item 4.3 de la MDS-UPDRS )
    - Taux de patients présentant des fluctuations non-motrices au bout des 18 mois de la Phase 1 (définies par l’échelle spécifique développée par l’équipe marseillaise participant au projet.
    - Délai d’apparition de dyskinésies défini comme étant la visite d’étude lors de laquelle l’investigateur répond « oui » pour la première fois à la question « à votre avis, ce patient présente-t-il des dyskinésies» telles que définies dans le protocole.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number of treatment arms in the trial2
    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 No
    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 years3
    E.8.9.1In the Member State concerned months6
    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 state202
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation réseau thématique Neurosciences-Parkinson des CIC
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-01
    P. End of Trial
    P.End of Trial StatusOngoing
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