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    Summary
    EudraCT Number:2007-002800-16
    Sponsor's Protocol Code Number:RBHP 2007 DURIF
    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:2007-08-27
    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 number2007-002800-16
    A.3Full title of the trial
    Reconnaissance des expressions émotionnelles du visage et classification émotionnelle de mots dans la maladie de Parkinson : Influence de la stimulation cérébrale profonde du noyau sous thalamique et de la L-Dopa.
    A.3.2Name or abbreviated title of the trial where available
    MPI-Emotions
    A.4.1Sponsor's protocol code numberRBHP 2007 DURIF
    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 SponsorCHU Clermont-Ferrand
    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 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 Modopar
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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 nameModopar
    D.3.4Pharmaceutical form Dispersible tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlévodopa
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number300
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbensérazide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number75
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nous étudions la reconnaissance d'expression faciales émotionnelles ainsi que la classification de mots émotionnels chez des patients atteints de la Maladie de Parkinson (avec ou sans traitement à la L-dopa, et/ou avec et sans stimulation cérébrale) en comparaison à des volontaires sains (sans traitement)
    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 cette étude est de déterminer l’existence d’un déficit de reconnaissance de certaines expressions émotionnelles chez les patients atteints de la maladie de Parkinson, avec une étude plus précise de l’information traitée par la voie sous-corticale de basse fréquence spatiale et celle traitée par la voie corticale de haute fréquence spatiale
    E.2.2Secondary objectives of the trial
    Les objectifs secondaires sont :
    - d’appréhender plus finement les capacités de traitement de l’information émotionnelle en testant leurs sensibilités à un phénomène d’amorçage émotionnel dans une tâche simple de décision lexicale
    - de mettre en évidence un lien étroit entre le traitement de l’information émotionnelle et la simulation de sa représentation (i.e., imitation des expressions faciales émotionnelles).
    - de tester l’impact de stimulation par électrode profonde des noyaux sous thalamiques ainsi que l’impact du traitement L-Dopa sur la perception d’expressions faciales émotionnelles
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pour les patients atteints de la Maladie de Parkinson :
    • Patients souffrant d'une maladie de Parkinson idiopathique selon les critères de l’UKPDSBB (Gibb & Lees, 1988; Hughes et al., 1992).
    • Patients pour qui une indication de stimulation cérébrale profonde a été posée selon des critères standardisés recommandés par l’ANAES (conférence de Consensus « maladie de Parkinson », mars 2000).
    • Effet de la stimulation ≥ 50%. Les patients du groupe 2 ne remplissant pas cette condition seront exclus de l’analyse statistique (Groupe 2). Ceci nous parait justifié car nous permet de confirmer que la stimulation du NST est optimale et peut donc influencer d’autres circuits que le circuit »moteur ».
    • Patients des deux sexes âgés de 30 à 75 ans.
    • Patients affiliés à un régime de sécurité sociale.
    • Patients volontaires ayant donné leur consentement écrit.

    Pour les volontaires sains :
    • Sujets homme ou femme âgés de 30-75 ans
    • Sujets affiliés à un régime de sécurité sociale.
    • Personnes volontaires ayant donné leur consentement écrit.
    E.4Principal exclusion criteria
    Pour les patients atteints de la Maladie de Parkinson :
    • Patients souffrant d'un syndrome parkinsonien atypique ou secondaire n'évoquant pas une maladie de Parkinson « idiopathique » (paralysie supranucléaire progressive, atrophie multisystématisée, post neuroleptique...).
    • Patients présentant des tremblements très sévères en pré-opératoire.
    • Patients présentant des « contre-indications » à l’utilisation du Modopar : hypersensibilité à la lévodopa ou au bensérazide, psychoses graves, confusion mentale, accidents cardiaques avec angor et troubles du rythme récents, glaucome à angle fermé, occlusion intestinale en raison de la présence d'huile de ricin, traitement à base de réserpine, neuroleptiques antiémétiques.
    • Patients présentant des troubles de la sensibilité aux contrastes
    • Patients présentant un défaut de la connaissance sémantique des mots associés à une émotion (Sprengelmeyer et al., 1997)
    • Patients sous tutelle ou curatelle ou sauvegarde de justice.
    • Patients en période d’exclusion d’une autre étude.

    Pour les témoins :
    • Personnes souffrant de pathologie neurologique et psychiatrique évolutive
    • Personnes sous tutelle ou curatelle ou sauvegarde de justice.
    • Personnes en période d’exclusion d’une autre étude
    E.5 End points
    E.5.1Primary end point(s)
    - La tâche de reconnaissance d’expressions faciales émotionnelles constitue notre critère d’évaluation principal : elle est réalisée sur PC avec le logiciel E-prime. Elle évalue la reconnaissance des 6 expressions émotionnelles (peur, dégoût, joie, colère, tristesse et surprise) et de l’expression neutre, dans 3 niveaux de contenu fréquentiels différents : images résolues (intégrales) / images BF / images HF. Elle dure environ 30 minutes Critère d’évaluation principal : le % de réponse correcte.

    - La tâche de décision lexicale constitue notre critère d’évaluation secondaire: elle consiste à reconnaître si une suite de lettres constitue un mot réel de la langue française. Les vrais mots sont des mots chargés émotionnellement précédés par une amorce subliminale. C’est la compétence dans le traitement des amorces qui sera analysée (durée : environ 30 min)
    Critère d’évaluation : le temps de latence de réponse.
    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 Information not present in EudraCT
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    physiopathologie
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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
    patients vs volontaires sains
    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 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
    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 months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-08-27. Yes
    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 state80
    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 Decision2007-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
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