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    Summary
    EudraCT Number:2006-005318-11
    Sponsor's Protocol Code Number:0602308
    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:2007-05-10
    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 number2006-005318-11
    A.3Full title of the trial
    Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons.
    A.4.1Sponsor's protocol code number0602308
    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 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
    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 APOKINON
    D.2.1.1.2Name of the Marketing Authorisation holderAGUETTANT
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous 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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous 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.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l’effet de l’administration aiguë d’apomorphine (agoniste dopaminergique) contre placebo sur le seuil nociceptif subjectif chez deux groupes de patients Parkinsoniens (douloureux et non douloureux)
    E.2.2Secondary objectives of the trial
    - Evaluer l’effet de l’apomorphine sur le seuil nociceptif objectif (Réflexe de flexion, RIII) dans les deux groupes de patients.
    - Evaluer l’effet de l’apomorphine sur l’activité des aires cérébrales au cours d’une stimulation expérimentale douloureuse en Tomographie par Emission de Positons (TEP) dans les deux groupes de patients.
    - Comparer les résultats des différents paramètres évalués entre les deux groupes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients souffrant d'une maladie de Parkinson idiopathique selon les critères de l’UKPDSBB (Gibb et Lees, 1988; Hughes et al, 1992)
    - Stade de Hoehn et Yahr inférieur ou égal à 3
    - Patients traités par médicaments antiparkinsoniens dopaminergiques (levodopa, agonistes dopaminergiques, IMAO-B, ICOMT...)
    - Patients des deux sexes âgés de 30 à 70 ans,
    - Patients affiliés à un régime de sécurité sociale

    Pour les patients appartenant au groupe « Parkinsoniens douloureux » :
    - Patients présentant des douleurs chroniques
    - Liées à la maladie de Parkinson.

    Pour les patients appartenant au groupe « Parkinsoniens non douloureux » :
    Patients ne présentant pas des douleurs chroniques liées à la maladie de Parkinson.
    E.4Principal exclusion criteria
    - Patients présentant une autre pathologie occasionnant des douleurs chroniques (maladies rhumatismales, pathologie traumatique ou orthopédique……)
    - Patients souffrant d’une affection cancéreuse
    - Patients sous tutelle ou curatelle ou sauvegarde de justice
    - Patients en période d’exclusion d’une autre étude.
    - Patients incapables de remplir les échelles prévues dans le cadre de cette étude
    - Patients ayant eu un examen TEP dans les trois mois précédents
    - Femme enceinte ou allaitante ou en âge de procréer sans contraception efficace
    - Patient présentant une contre-indication absolue à l’injection d’apomorphine
    - Patient présentant une contre-indication à la dompéridone : hypersensibilité à la dompéridone ou à l'un de ses excipients, tumeur hypophysaire à prolactine (prolactinome), hémorragie gastro-intestinale, obstruction mécanique ou perforation digestive.
    E.5 End points
    E.5.1Primary end point(s)
    Critère de jugement principal : seuil nociceptif thermique subjectif

    Les stimulations thermiques seront réalisées à l’aide d’un thermotest (MSA Thermotest, Somedic AB, Sweden) (Frushstorfer et al, 1976). Une thermode de contact de 12X25mm sera placée au contact de l’éminence thénar du patient.
    Nous déterminerons le seuil nociceptif propre à chacun des sujets. Pour cela, nous utiliserons la méthode des seuils qui ne dépend pas du temps de réaction (Gescheider, 1985 ; Gracely, 1989).
    La détermination du seuil douloureux sera effectuée sur l’hémicorps le plus atteint par la maladie.
    Méthode des seuils (method of levels) : La température initiale de la thermode étant de 30ºC, le patient recevra pendant 30 secondes une température de +3°C . Immédiatement après chaque stimulation thermique, on demandera au patient s’il a ressenti ou non une sensation douloureuse ;
    En cas de réponse négative, la température sera alors augmentée de 3ºC et appliquée à nouveau durant 30 secondes, jusqu'à ce que le patient ressente une sensation douloureuse ;
    En cas de réponse positive, la température sera diminuée de 1.5°C (la moitié de 3°C) et appliquée à nouveau pendant 30 secondes. Le seuil sera ensuite progressivement ajusté jusqu'à obtenir une température comprise entre deux intervalles proches de 0,2ºC. Un intervalle de 30 secondes était respecté entre chaque stimulation. Deux séries de stimulations seront réalisées et le seuil subjectif sera défini comme la moyenne des deux.
    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
    physiopathologie
    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) 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 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 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 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
    Dernière visite du dernier patient participant à l'étude
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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 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 state32
    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)
    Reprise du traitement habituel
    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 Decision2007-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-27
    P. End of Trial
    P.End of Trial StatusOngoing
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