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    Summary
    EudraCT Number:2019-002973-77
    Sponsor's Protocol Code Number:2019-002973-77
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-06
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-002973-77
    A.3Full title of the trial
    Multimodal quantification of cortical microstructure and synaptic density in MS patients
    Quantification multimodale de la microstructure et de la densité synaptique corticale chez des patients souffrant de sclérose en plaques
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neuroimaging of the structure and synaptic contacts of the brain of patients with multiple sclerosis
    Etude par des techniques de neuro-imagerie de la structure et des contacts synaptiques du cerveau de patients atteints de sclérose en plaques
    A.3.2Name or abbreviated title of the trial where available
    MS_SV2
    A.4.1Sponsor's protocol code number2019-002973-77
    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 SponsorService de Neurologie, CHU Liège
    B.1.3.4CountryBelgium
    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 of Liège
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportFonds L2on Frédéricq
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Liège
    B.5.2Functional name of contact pointGIGA-CRC in vivo imaging
    B.5.3 Address:
    B.5.3.1Street Addressallée du 6 août,8
    B.5.3.2Town/ cityLiege
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3243662316
    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]UCB-H
    D.3.2Product code [18F]UCB-H
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[18F]UCB-H
    D.3.9.1CAS number 1774352-40-7
    D.3.9.2Current sponsor code[18F]UCB-H
    D.3.9.3Other descriptive name[18F]UCB-H
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number185
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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
    Multiple sclerosis
    Sclérose en plaques
    E.1.1.1Medical condition in easily understood language
    Muliple sclerosis
    Sclérose en plaques
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary aim of the study is to assess regional brain synaptic density in MS patients of various duration and to determine whether a significant regional decrease in synaptic density can be detected, at the individual level, in comparison to age-matched healthy participants, using PET scanning and [18F]-UCB-H.
    L'étude vise à déterminer si la densité synaptique régionale cérébrale du cerveau de patients atteints de sclérose en plaques, telle qu'estimée en tomographie à émission de positons par injection de [18F]-UCB-H, diffère de celle de participants sains.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants, selected at the specialized MS outpatient clinic of the CHU of Liège, consist of patients with a diagnosis of RRMS according to Mc Donald criteria 2017, with no evidence of clinical progression. In order to eschew interference of recurrent relapses, patients have to be relapse-free for at least 6 months at the time of inclusion. Other inclusion criteria include:
    - Willingness to participate to the study
    - Good general health (except for MS)
    - Visual and auditory acuity adequate for testing
    - Completed at least six grades of education (i.e., exclude mental retardation)

    In addition, healthy control participants, matched with patients for sex, age and socio-cultural level will be recruited through advertising in local newspapers, radios, communities, sport clubs and word of mouth. Inclusion criteria are the same as for patients, with the exception of MS.
    Des patients souffrant de la forme rémittente de la sclérose en plaques, sans signe de rpogression, seront recrutés à la policlinique de neuroimmunologie du CHU de Liège, selon les critères diagnostiques de McDonald 2017. Les patients devront être libres de toute poussée depuis 6 mois au moins.
    Comme autres critères d 'inclusion, citons:
    - le consentement à participé à l'étude
    - une bonne santé générale, en dehors de la sclérose en plaques
    - une bonne vue et une audition normale
    - une éducation d'un niveau minimum d'école primaire.
    Des participants sains seront recrutés par voie d'affiche, appels radio, clubs de sport, etc selon les mêmes critères d'inclusion, excepté la sclérose en plaques.
    E.4Principal exclusion criteria
    - Presence or history of neurological diseases other than MS, psychiatry diseases, major traumatic brain injury, major surgery , uncontrolled infection or medical condition, Female patient without contraception, physical or behavioural state incompatible with the current protocol (including MR compatibility, pregnancy, tutorship or guardianship.
    - Antécédent ou présence d'une maladie du système nerveux autre que la sclérose en plaques, d'une infection ou d'une inflammation du système nerveux central, néoplasies, maladies non contrôlée de causes carentielles, toxiques ou métaboliques, trouble du sommeil majeur, épilepsie.
    - Antécédent de maladie psychiatrique majeure
    - Antécédent de traumatisme crânien majeur
    - Antécédent de chirurgie majeure (cœur, cerveau)
    - Traitement modifiant le métabolisme cérébral, en dehors des traitements de la sclérose en plaques
    - Patiente sans contraception, enceinte ou allaitante
    - État physique incompatible avec le protocole.
    E.5 End points
    E.5.1Primary end point(s)
    (1) Acquisition of data for 50 participants,
    (2) Last inclusion in the trial
    (3)Map of significant regional differences in synaptic density, R1, R2*, MT and QSM beween MS patients and normal controls.
    (1) Acquisition des données sur 50 participants;
    (2) Dernière inclusion dans l'essai
    (3) Génération des cartes de différences statistiques entre groupes
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint : Final analysis of data.
    Génération des cartes de différences statistiques entre groupes
    E.5.2Secondary end point(s)
    NA
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 Yes
    E.6.13.1Other scope of the trial description
    Physiopathogeny of MS
    Physiopathologie de la sclérose en plaques
    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 Yes
    E.8.1.7.1Other trial design description
    Physiopathologie
    Physiopathology
    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 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 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: 50
    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 Yes
    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 state100
    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, but the routine clinical follow up
    Aucun, en dehors du suivi clinique normal
    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 Decision2020-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-03
    P. End of Trial
    P.End of Trial StatusOngoing
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