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    Summary
    EudraCT Number:2015-002375-22
    Sponsor's Protocol Code Number:38RC15.173
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-06-26
    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 number2015-002375-22
    A.3Full title of the trial
    Study the diffusion kinetics of gadolinium at the perilymph of the inner ear structures to patients Meniere's disease
    Etude de la cinétique de diffusion du gadolinium au niveau des structures périlymphatiques de l’oreille interne pour des patients atteints de maladie de Ménière
    A.3.2Name or abbreviated title of the trial where available
    PROSPER
    PROSPER
    A.4.1Sponsor's protocol code number38RC15.173
    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 SponsorUniversity Hospital Grenoble
    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 supportUniversity Hospital Grenoble
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital grenoble
    B.5.2Functional name of contact pointDr Arnaud ATTYE
    B.5.3 Address:
    B.5.3.1Street AddressClinique universitaire de Neuroradiologie diagnostique et IRM
    B.5.3.2Town/ cityGrenoble
    B.5.3.3Post code38043
    B.5.3.4CountryFrance
    B.5.4Telephone number3304 76 76 34 50
    B.5.5Fax number3304 76 76 52 86
    B.5.6E-mailAAttye@chu-grenoble.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 Yes
    D.2.1.1.1Trade name DOTAREM
    D.2.1.1.2Name of the Marketing Authorisation holderGuerbet
    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 nameDOTAREM
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients Meniere's disease
    Patients atteints de maladie de Ménière
    E.1.1.1Medical condition in easily understood language
    Meniere's disease
    maladie de Ménière
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10027183
    E.1.2Term Meniere's disease
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Development of a diagnostic test MRI of Meniere's disease, including a prodromal stage, for studying the vascular permeability of the inner ear.
    Mise au point d’un test diagnostic en IRM de la maladie de Ménière, y compris à un stade prodromal, par étude de la perméabilité vasculaire de l’oreille interne.
    E.2.2Secondary objectives of the trial
    • Study of the central auditory pathways in search of brain damage associated with cochleovestibular reached.

    • Study of the sensitivity and specificity of early and late MRI in detecting confrontation in Meniere's disease with electrophysiological ENT examinations: electrocochleography, otoacoustic emissions and evoked potentials otolithic
    • Etude des voies auditives centrales à la recherche de lésions cérébrales associées à l’atteinte cochléo-vestibulaire.

    • Etude de la sensibilité et de la spécificité de l’IRM précoce et tardive dans la détection de la maladie de Ménière en confrontation avec les examens électrophysiologiques ORL : l’électrocochléographie, les otoémissions acoustiques et les potentiels évoqués otolithiques
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects with the following criteria may be included in this study:
    • Major subjects of over 50 years (mean age of Meniere's disease 40 to 50 years (Sajjadi and Paparella, 2008), 55 years in our sample)
    • Informed consent signed
    • Medical examination performed prior to participation in research
    • Patients with clinical criteria of Meniere's disease according to the classification of the American Association of Otology (ie the combination of a sensorineural hearing loss at low frequencies, recurrent vertigo and tinnitus and / or clogged ear sensation)
    • Recipient of a French social security scheme
    Tous les sujets présentant les critères suivants pourront être inclus dans cette étude :
    • Sujets majeurs de plus de 50 ans (âge moyen de la maladie de Ménière entre 40 et 50 ans (Sajjadi and Paparella, 2008), 55 ans dans notre échantillon)
    • Consentement éclairé signé
    • Examen médical effectué avant la participation à la recherche
    • Patients présentant des critères définis de maladie de Ménière clinique selon la classification de l’association américaine d’otologie (à savoir l’association d’une surdité de perception sur les basses fréquences, de vertiges récurrents et d’acouphènes et/ou de sensation d’oreille bouchée)
    • Bénéficiaire d’un régime de sécurité social français
    E.4Principal exclusion criteria
    • Patients minors
    • Patients on a legal protection regime type guardianship
    • Respiratory pathologies, cardiovascular, renal, diabetes
    • Claustrophobia
    • Contraindications to exposure to a magnetic field
    • Contraindications to injecting Dotarem ®
    • Patients mineurs
    • Patients sous un régime de protection juridique de type tutelle ou curatelle
    • Pathologies respiratoires, cardio-vasculaires, rénales, diabète
    • Claustrophobie
    • Contre-indication à l’exposition à un champ magnétique
    • Contre-indication à l’injection de Dotarem ®
    E.5 End points
    E.5.1Primary end point(s)
    Quantitative study by the method of the interest areas of enhancement kinetics in the first 4 hours after injection of a single intravenous dose of gadoteric acid in the cochlea of patients with Meniere's disease. These repeat sequences in hyperpondération T2 minutes at regular intervals to quantify the shortening of the relaxation time and the echo delay for product to pass across the blood Gadoline-labyrinthine barrier
    • Etude quantitative par la méthode des régions d’intérêt de la cinétique de rehaussement dans les 4 premières heures après injection d’une simple dose intraveineuse d’acide gadotérique dans la cochlée de patients atteints de maladie de de Ménière. Il s’agit de répéter des séquences en hyperpondération T2 de quelques minutes à intervalle régulier pour quantifier le raccourcissement du temps de relaxation et du temps d’écho lié au passage du produit gadoliné à travers la barrière hémato-labyrinthique
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 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 No
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 state47
    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)
    None
    non
    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 Decision2015-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-05-30
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