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    Summary
    EudraCT Number:2017-003381-27
    Sponsor's Protocol Code Number:100045
    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:2018-07-24
    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 number2017-003381-27
    A.3Full title of the trial
    Study in 18F-DPA714 PET to better locate preoperatively the epileptic focus to resect in drug-resistant partial epilepsy
    Etude en 18F-DPA714 TEP pour mieux localiser en préopératoire le foyer épileptique à réséquer dans l'épilepsie partielle pharmacorésistante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in 18F-DPA714 PET to better locate preoperatively the epileptic focus to resect in drug-resistant partial epilepsy
    tude en 18F-DPA714 TEP pour mieux localiser en préopératoire le foyer épileptique à réséquer dans l'épilepsie partielle pharmacorésistante
    A.3.2Name or abbreviated title of the trial where available
    Epi-TEP
    Epi-TEP
    A.4.1Sponsor's protocol code number100045
    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 SponsorCEA
    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 supportCEA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCEA
    B.5.2Functional name of contact pointBernadette Martins
    B.5.3 Address:
    B.5.3.1Street AddressCEA NeuroSpin
    B.5.3.2Town/ cityGif sur Yvette
    B.5.3.3Post code91190
    B.5.3.4CountryFrance
    B.5.4Telephone number33169087460
    B.5.5Fax number33169087125
    B.5.6E-mailbernadette.martins@cea.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.2.5The 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 name[18F]DPA-714
    D.3.2Product code [18F]DPA-714
    D.3.4Pharmaceutical form 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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Brain imaging on people with partial pharmaco resistant epilepsy
    Imagerie du cerveau de sujets présentant une épilepsie partielle pharmaco résistante
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    Evaluer l'apport de l'imagerie TEP au 18 F-DPA-714 pour la localisation de la zone responsable des crises chez des patients souffrant d'une épilepsie partielle pharmacorésistante et candidats à la chirurgie au cours de leur bilan de phase 2
    E.2.2Secondary objectives of the trial
    - Feasibility and tolerance of the procedure
    - Efficacy at one year of the surgical procedure in the case of ablation of the fate designated by imaging
    - Study factors associated with surgery failure versus imaging data
    - To study the results of the imaging of the patients rejected at the end of the SEEG
    - Faisabilité et tolérance de la procédure
    - Efficacité à un an de l'intervention chirurgicale en cas d'ablation du foyé désigné par l'imagerie
    - Etudier les facteurs associés à l'échec de la chirurgie par rapport aux données de l'imagerie
    - Etudier les résultats de l'imagerie des patients récusés à l'issue de la SEEG
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - patients with PPRE
    - over 12 years old
    the PPRE confirmed having performed a presurgical phase 1 evaluation and where the results have concluded the need for a SEEG
    - The patient and/or legal representative have given their consent, the child acccepts to participate
    - TSPO genetic
    - épilepsie pharmaco résistante ( après 2 traitements)
    - age supérieur à 12 ans
    - épilepsie partielle pharmacorésistante ayant bénéficié d'un bilan préchirurgical ou phase 1 dont les résultats nécessitent de recourir à une SEEG
    - Consentement du sujet majeur, des parents et assentiment de l'enfant pour les mineurs
    Génotypage pour l'expression de la protéine TSPO permettant la fixation du traceur (90 % des sujets)
    E.4Principal exclusion criteria
    - Contra-indication to MRI
    - Pregnant or lactating women or women with no contraception
    - Patients unable to maintain an elongated, lying flat position for a prolonged period
    - Patients already included in another study
    - Patients taking benzodiazepine treatment which could have a confounding affect bon the affinity ot the radiotracer and should be stopped 15 D before the PET
    Contre-indication à l'IRM
    - Femmes enceintes ou allaitantes ou femmes sans contraception
    - Patients incapables de maintenir une position allongée et allongée à plat pendant une période prolongée
    - Patients déjà inclus dans une autre étude
    - Les patients prenant un traitement à la benzodiazépine qui pourrait avoir un facteur de confusion affectent l'affinité du radiotraceur et doivent être arrêtés 15 jours avant le PET.
    - CI à un examen IRM
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the contribution of PET imaging to 18 F-DPA-714 for the localization of the area responsible for seizures in patients from 12 years of age suffering from pharmaco-resistant partial epilepsy and candidates for surgery during their balance sheet
    Evaluer l'apport de l'imagerie TEP au 18 F-DPA-714 pour la localisation de la zone responsable des crises chez des patients à partir de 12 ans souffrant d'une épilepsie partielle pharmaco résistante et candidats à la chirurgie au cours de leur bilan
    E.5.1.1Timepoint(s) of evaluation of this end point
    Percentage of subjects in whom the epileptogenic volume defined by the SEEG performed according to the electrode implantation plan determined with the PET-MRI imaging data has been modified with good reason compared to the implantation plan of the electrodes determined without the multimodal imaging data
    Pourcentage de sujets chez qui le volume épileptogène défini par la SEEG réalisée selon le plan d'implantation des électrodes déterminé avec les données de l'imagerie TEP-IRM aura été modifié à juste raison par rapport au plan d'implantation des électrodes déterminé sans les données de l'imagerie multimodale
    E.5.2Secondary end point(s)
    - Evaluate the feasibility and the tolerance of the whole procedure.
    - To evaluate the effectiveness at 1 year of the surgical procedure in case of removal of the designated hearth by imaging.
    - To study the influence of the "type of epilepsy" (localization, etiology) on the imaging results.
    - To study the factors associated with the failure of the surgery compared to the data of the imagery.
    - Compare the resected volume in surgery and the volume defined from the results of the imaging.
    -Study the imaging results of patients challenged at the end of SEEG.
    -Conversion of the topography of the 18F-DPA-714 PET imaging data to that of MRI imaging (diffusion tensor and morphological MRI T1 and T2)
    - Assessment of the impact of epileptic focus on the remote functioning of the brain (functional MRI rest)
    -Evaluer la faisabilité et la tolérance de l’ensemble de la procédure.
    - Evaluer l’efficacité à 1 an de l’intervention chirurgicale en cas d’ablation du foyer désigné par l’imagerie.
    - Etudier l’influence du "type d'épilepsie" (localisation, étiologie) sur les résultats en imagerie.
    - Etudier les facteurs associés à l’échec de la chirurgie par rapport aux données de l’imagerie.
    - Comparer le volume réséqué en chirurgie et le volume défini à partir des résultats de l’imagerie.
    -Etudier les résultats de l’imagerie des patients récusés à l’issue de la SEEG.
    -Confronter la topographie des données de l’imagerie TEP au 18F-DPA-714 à celles de l’imagerie IRM (tenseur de diffusion et IRM morphologique T1 et T2)
    - Evaluation du retentissement du foyer épileptique sur le fonctionnement à distance du cerveau (MRI fonctionnelle de repos)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Collection and analysis of adverse events and their causal relationship to the entire evaluated procedure.
    - Number of subjects who benefited from the whole procedure according to the protocol.
    - Number of seizures in patients 1 year after surgery (ILAE classification).
    - Study of the results in imaging subgroups of patients according to the type of their epilepsy (the temporal or extra-temporal location, the etiology of their epilepsy, the frequency of seizures).
    - Imaging data in patients not cured by surgery
    - Imaging data in patients challenged after SEEG
    - Recueil et analyse des événements indésirables et de leur relation de causalité par rapport à l’ensemble de la procédure évaluée.
    - Nombre de sujets ayant pu bénéficier de l’ensemble de la procédure conformément au protocole.
    - Nombre de crises chez les patients 1 an après l’intervention chirurgicale (classification ILAE).
    - Etude des résultats en imagerie de sous-groupes de patients selon le type de leur épilepsie (la localisation temporale ou extra temporale, l’étiologie de leur l’épilepsie, la fréquence des crises).
    - Données de l’imagerie chez les patients non guéris par la chirurgie
    - Données de l’imagerie chez les patients récusés après SEEG
    -
    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 Yes
    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 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.8.1.7.1Other trial design description
    étude pilote
    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.8.3 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 years3
    E.8.9.1In the Member State concerned months
    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 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) No
    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 state30
    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
    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 Decision2018-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
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