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    Summary
    EudraCT Number:2018-001584-23
    Sponsor's Protocol Code Number:7605
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-27
    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 number2018-001584-23
    A.3Full title of the trial
    "Microglial Activation in Narcolepsy Type 1: Positron Emission Tomography (PET) Study in [18F] DPA-714"
    "Activation microgliale dans la Narcolepsie de type 1: Etude en tomographie par émission de positons (TEP) au [18F]DPA-714"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    "Activation microgliale dans la Narcolepsie de type 1: medical imaging study"
    "Activation microgliale dans la Narcolepsie de type 1: Etude d'imagerie médicale"
    A.3.2Name or abbreviated title of the trial where available
    Narcoglie
    Narcoglie
    A.4.1Sponsor's protocol code number7605
    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 of Montpellier
    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 of Montpellier
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationResearch Department of Montpellier Hospital
    B.5.2Functional name of contact pointResearch Departmen _ sponsor Unit
    B.5.3 Address:
    B.5.3.1Street AddressHopital La Colombière, 39 avenue Charles Flahault
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number0033467330924
    B.5.5Fax number0033467339172
    B.5.6E-mailc-chauveton@chu-umontpellier.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 nameN,N-diethyl-2-[4-(2-fluoroethoxy)phenyl]-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide
    D.3.4Pharmaceutical form Solution for 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 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 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
    To study in vivo microglial activation by PET [18F] DPA-714 in NT1 patients with recent evolution (appearance of the first symptoms - somnolence and cataplexy-less than 2 years ago) compared with controlled subjects (followed for another pathology of sleep without narcolepsy or hypersomnia) matched in age and sex.
    Il s'agit d'étudier l'activation microgliale in vivo par TEP [18F]DPA-714 chez des patients NT1 avec évolution récente ( apparition des premiers symptômes - somnolence et cataplexies- il y a moins de 2 ans) en comparaison à des sujets contrôles (suivis pour une autre pathologie du sommeil sans narcolepsie ni hypersomnie) appariés en âge et sexe.
    E.1.1.1Medical condition in easily understood language
    Perform a medical imaging examination in patients with NT1 compared to control subjects (followed for another pathology of sleep without narcolepsy or hypersomnia).
    Réaliser un examen d'imagerie médicale chez des patients atteints de NT1 en comparaison à des sujets contrôles (suivis pour une autre pathologie du sommeil sans narcolepsie ni hypersomnie) .
    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
    To study hypothalamic cerebral microglial activation in NT1 patients compared to matched controls in age and sex. The PET [18F] DPA-714 data will be recalibrated on a cerebral MRI for the SPM standardization step, then hypothalamic interest volumes (VOI) will be isolated and a semi-quantitative evaluation will be performed at various instants of time. dynamic acquisition.
    Objectiver une activation microgliale cérébrale hypothalamique chez des patients NT1 en comparaison à des sujets témoins appariés en âge et sexe. Les données de TEP[18F]DPA-714 seront recalées sur une IRM cérébrale de référence pour l’étape standardisation sous SPM, puis des volumes d’intérêts (VOI) hypothalamiques seront isolés et une évaluation semi-quantitative sera réalisée à divers instants de l’acquisition dynamique.
    E.2.2Secondary objectives of the trial
    To study the relationship between (1) microglial activation in the whole brain, at the level of the hypothalamus and neighboring regions (thalamus), and (2) clinical characteristics (age of onset of symptoms, duration of evolution , severity of symptoms) and polysomnographic, and (3) Hcrt levels in the CSF, and proinflammatory cytokines in the CSF and serum in the NT1 patient population.
    Etudier la relation entre (1) l’activation microgliale dans l’ensemble du cerveau, au niveau de l’hypothalamus et des régions voisines (thalamus), et (2) les caractéristiques cliniques (âge de début des symptômes, durée d’évolution, sévérité des symptômes) et polysomnographiques, et (3) les taux d’Hcrt dans le LCR, et de cytokines proinflammatoires dans le LCR et le serum dans la population de patients NT1.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Narcoleptic patients Inclusion Criteria :
    - Clinical diagnosis of NT1 according to International Classification of Sleep Disorders, 3rd Edition (AASM: American Academy of Sleep Medicine, 2014), with beginning of symptoma since 2 years top (somnolence and/or cataplexy)
    - With or without psychostimulant treatment for the pathology
    Control patients Inclusion Criteria :
    - Sleep disorder without objectification of narcolepsy or hypersomnia and without any inflammatory pathology.
    Non-specific Inclusion Criteria :
    - Age over 18
    - Absence of contraindication to the performance of PET [18F] DPA-714
    - Absence of immunomodulatory or anti-inflammatory treatment
    - Subjects having given their written and informed consent for this study
    - Subjects speaking and including French
    - Affiliated to social security
    Critères d’inclusion du groupe de patients narcoleptiques :
    - Patients avec un diagnostic clinique de NT1 selon les critères internationaux (International Classification of Sleep Disorders, 3rd Edition) (AASM: American Academy of Sleep Medicine, 2014), suivis au CHU de Nîmes et au Centre National de Référence Narcolepsie-Hypersomnie de Montpellier, avec un début des symptômes (somnolence et/ou cataplexies) datant d’au maximum deux ans. Les critères ICSD-3 sont : somnolence diurne excessive évoluant depuis au moins 3 mois, et présence d’un ou 2 des éléments suivants : (1) cataplexies bien définies et latence moyenne d’endormissement inférieure ou égale à 8 minutes au test itératif de latence d’endormissement, et au moins 2 endormissements en sommeil paradoxal (ESP) (un ESP la nuit précédente peut remplacer un ESP au TILE), (2) un taux d’hypocrétine dans le LCR inférieur ou égal à 110 pg/mL.
    - Traitement ou non par des psychostimulants dans le cadre de leur pathologie
    Critères d’inclusion du groupe de témoins :
    Patients présentant un trouble du sommeil sans objectivation de narcolepsie ou d’hypersomnie et indemnes de toute pathologie inflammatoire.
    Critères d’inclusion non spécifiques (patients et témoins) :
    - Age supérieur à 18 ans
    - Absence de contre-indication à la réalisation du TEP au [18F]DPA-714
    - Absence de traitement immunomodulateur ou anti-inflammatoire
    - Sujets ayant donné leur consentement écrit et éclairé pour cette étude
    - Sujets parlant et comprenant le français
    - Affiliés à un régime de Sécurité Sociale ou bénéficiaire d’un tel régime
    E.4Principal exclusion criteria
    Exclusion Criteria (non-specific patients/control) :
    - Refusal to perform PET Imaging in [18F] DPA-714
    - Pregnant or lactating women
    - Subject deprived of liberty, by judicial or administrative decision
    - Major protected by law
    - Subject without social security
    - Subject in exclusion period after another protocol
    - Refusal to participate in the protocol
    - Contraindications to MRI
    Critères de non inclusion (non spécifiques, patients et témoins) :
    - Refus de réalisation de l’imagerie TEP au [18F]DPA-714
    - Femmes enceintes ou allaitantes
    - Sujet privé de liberté, par décision judiciaire ou administrative
    - Majeur protégé par la loi
    - Sujet non affilié à un régime de sécurité sociale, ou non bénéficiaire d’un tel régime
    - Sujet en période d’exclusion relative par rapport à un autre protocole
    - Refus de participer au protocole
    -Contre-indication à l’IRM : Contre-indication pour la réalisation d’une IRM (patients porteurs d’un pacemaker, d’une prothèse valvulaire mécanique non compatible avec l’IRM, patients porteurs d’un implant cochléaire, patients porteur d'un clip anévrismal, présence d'un corps étranger métallique intra-oculaire, ou de certaines endoprothèses coronariennes…)
    E.5 End points
    E.5.1Primary end point(s)
    Hypothalamic microglial activation level, using [18F] DPA-714 dynamic PET data (in 40 minute LIST mode).
    Le critère d’évaluation principal portera sur le niveau d’activation microgliale hypothalamique en utilisant les données TEP dynamiques au [18F]DPA-714 (en mode LIST sur 40 minutes).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month after inclusion
    Visite 2 (environ 1 mois après l'inclusion)
    E.5.2Secondary end point(s)
    Search of the links between:
    (1) The mean [18F] DPA-714 SUV measurement at the different regions of interest (including the hypothalamus and thalamus) defined in brain CT after MRI referral and anatomical standardization in the MNI space, and
    (2) The clinical data of the disease (age of onset of symptoms, severity of symptoms), and electrophysiology (sleep latency and number of sleep in paradoxical sleep),
    (3) Hcrt levels in CSF and pro-inflammatory cytokines measured in serum and CSF of narcoleptic patients.
    Il sera recherché des liens entre :
    (1) La mesure moyenne des SUV du [18F] DPA-714 au niveau des différentes régions d’intérêt (parmi lesquelles l’hypothalamus et le thalamus) définies sur le TEP cérébral après recalage sur IRM de référence et standardisation anatomique dans l’espace MNI, et
    (2) Les données cliniques de la maladie (âge de début des symptômes, sévérité des symptômes), et électrophysiologiques (latence d’endormissement et nombre d’endormissements en sommeil paradoxal),
    (3) Le taux d’Hcrt dans le LCR et de cytokines pro-inflammatoires mesurées dans le sérum et le LCR des patients narcoleptiques.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 month after inclusion
    Visite 2 (environ 1 mois après l'inclusion)
    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 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 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Patient témoin avec trouble du sommeil sans narcolepsie, hypersomnie ni pathologie inflammatoire
    Patient control without sleep disorder, narcolepsy, hypersomnia or inflammatory pathology
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    3 months after the LVLS
    3 mois après la dernière visite de suivi
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    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 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.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 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 Decision2018-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-03
    P. End of Trial
    P.End of Trial StatusCompleted
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