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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    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).

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    Summary
    EudraCT Number:2007-000359-33
    Sponsor's Protocol Code Number:0604002
    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:2007-05-11
    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 number2007-000359-33
    A.3Full title of the trial
    PENOMBRE HYPOXIQUE ET ISCHEMIE SEMI-TARDIVE ETUDIEE EN TEP AU
    18F-FLUOROMISONIDAZOLE : IMPACT SUR LA RECUPERATION FONCTIONNELLE DANS LES SUITES D’UN AVC ISCHEMIQUE AVEC DEFICIT MOTEUR. Etude de faisabilité
    A.4.1Sponsor's protocol code number0604002
    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 No
    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 name18F-FLUOROMIZONIDAZOLE
    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 IMPIntravenous 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 Yes
    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
    Accident vasculaire cérébral
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008121
    E.1.2Term Cerebral ischemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1- Objectif fonctionnel : évaluer les conditions de mise en place de la technique d’identification de la pénombre ischémique à la phase aigue d’un accident vasculaire cérébral par le 18F- fluoromisonidazole en tomographie par émission de positons.
    2- Objectif Clinique : Identifier le tissu hypoxique et la zone pénombre ischémique semi-tardive au moyen du PET à la FMISO et ainsi décrire l’histoire naturelle de la pénombre ischémique sur une population sélectionnée de patients et à évaluer l’impact sur le pronostic fonctionnel de l’évolution de cette pénombre. Etablir une corrélation entre la proportion de ce tissu qui ne s’infarcit pas, et la récupération neurologique et fonctionnelle de nos malades, récupération évaluée par les scores de NIH et de Rankin modifié.
    E.2.2Secondary objectives of the trial
    - Montrer que le volume de souffrance ischémique initiale, défini par l’addition du tissu hypoxique et du tissu d’ores et déjà infarci, est corrélé au niveau de déficit clinique constaté chez nos patients.
    - Montrer que le volume hypoxique décroît avec le temps mais qu’il persiste jusqu’à la 36ème heure au moins après le début des symptômes, et qu’il peut rester important l’échelle individuelle, même à ce stade semi-tardif.
    - Mettre en évidence une corrélation, dont le sens reste à déterminer, entre le délai de réalisation de l’examen PET (et donc le délai d’étude de cette pénombre ischémique), et la proportion de tissu hypoxique de façon réversible, c’est à dire qui sera sauvé spontanément.
    - Comparer le pronostic défini par cette méthode à celui évalué au moyen de la mesure de la réponse motrice évoquée (PEM) après stimulation magnétique transcorticale à la phase aiguë.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age de 18 à 90 ans
    - Premier accident vasculaire cérébral hémisphérique ischémique symptomatique
    - Possibilité de réaliser l’examen PET dans les 36 heures suivant le début des symptômes
    - NIHSS supérieur ou égal à 5 et NIHSS inférieur à 20
    - Score de Rankin modifié compris entre 1 et 5.
    - Consentement éclairé
    - Affiliation à un régime de sécurité sociale.
    E.4Principal exclusion criteria
    - Femmes enceintes ou allaitantes
    - Femme en âge de procréer n’utilisant aucune méthode de contraception médicalement acceptée
    - Personnes sous tutelle ou curatelle ou sous sauvegarde de justice
    - Patient en période d’exclusion pour un autre protocole de recherche clinique
    - Maladie concomitante entraînant un pronostic vital défavorable dans les 3 mois suivant l‘inclusion
    - Participation à un protocole avec radiations ionisantes dans l’année précédente
    - Contre-indication à un examen par résonance magnétique et par TMS : contre-indication relative, car sinon le patient aura un TDM cérébral et ne bénéficiera pas de la TMS, qui est un objectif secondaire) : Stimulateur cardiaque, prothèses métalliques, neurostimulateurs, Clips neurochirurgicaux, sutures métalliques, agrafes, valve cardiaque métallique, valve de dérivation ventriculaire, travailleurs des métaux, corps étrangers oculaires, éclats d’obus, balle, implants cochléaires.
    - Patient dont l’état neurologique contre indique l’examen PET
    - Patient ayant bénéficié d’un examen PET dans le mois précédent
    - Patient dans le coma ne pouvant être examiné et évalué objectivement sur le plan neurologique (score de Rankin modifié, NIHSS)
    - Patient intubé, ventilé, sédaté
    - Patient ayant été traité à la phase aiguë par fibrinolyse intra-veineuse par le r-tPA
    - Hémorragie cérébrale intra-parenchymateuse et/ou sous-arachnoïdienne.
    E.5 End points
    E.5.1Primary end point(s)
    - faisabilité de la technique : fiabilité de la synthèse, décours temporel logistique entre l’admission de patient et la réalisation de l’examen PET, en comprenant les différentes étapes, recueil des données, interprétation des données, la capacité à identifier des aires cérébrales fixant le 18F-fluoromisonidazole et témoins d’une hypoxie focale persistante
    - critère clinique : corrélation entre le SHVR (surviving hypoxic volume ratio) et la progression du score de NIHSS (National Institute of Health Stroke Score) entre J0 et J7-J10.
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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 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 Yes
    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 state10
    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 Decision2007-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-06
    P. End of Trial
    P.End of Trial StatusOngoing
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