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    Summary
    EudraCT Number:2013-002113-35
    Sponsor's Protocol Code Number:MD1003CT2013-02MS-SPI
    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:2015-05-29
    Trial results View 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 number2013-002113-35
    A.3Full title of the trial
    Effect of MD1003 in spinal progressive multiple sclerosis: a pivotal randomized double blind placebo controlled study
    MD1003 dans le traitement des formes progressives spinales de sclerose en plaques: Etude pivot randomisée en double insu versus placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of MD1003 in progressive multiple sclerosis with walking impairment
    MD1003 dans le traitement des formes progressives de sclerose en plaques avec troubles de la marche
    A.3.2Name or abbreviated title of the trial where available
    MS-SPI
    MS-SPI
    A.4.1Sponsor's protocol code numberMD1003CT2013-02MS-SPI
    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 SponsorMEDDAY SAS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMEDDAY SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMEDDAY SAS
    B.5.2Functional name of contact pointClinical trials Information
    B.5.3 Address:
    B.5.3.1Street Address26 rue des rigoles
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75020
    B.5.3.4CountryFrance
    B.5.6E-mailguillaume.brion@medday-pharma.com
    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 namebiotin
    D.3.2Product code MD1003
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIOTIN
    D.3.9.1CAS number 58-85-5
    D.3.9.4EV Substance CodeSUB05841MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Progressive spinal multiple sclerosis
    Formes progressives spinales de sclérose en plaques
    E.1.1.1Medical condition in easily understood language
    Progressive multiple sclerosis
    Sclérose en plaques progressive
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10053395
    E.1.2Term Progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the superiority of Biotin 300 mg/day over placebo in clinical improvement of patients with spinal progressive multiple sclerosis
    Démontrer la supériorité de la biotine à 300 mg/jour par rapport à un placebo dans l'amélioration clinique des patients atteints de sclérose en plaques progressive
    E.2.2Secondary objectives of the trial
    1) To assess the efficacy of biotin at 300 mg/day versus 100mg/day in the clinical improvement of patients with spinal progressive multiple sclerosis.
    2) To evaluate the safety of high doses of biotin
    1) Evaluer l'efficacité de la biotine 300 mg/jour versus 100 mg/jour chez des patients atteints de sclérose en plaques progressive.
    2) Evaluer la sécurité de la biotine à forte dose
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Diagnosis criteria of secondary or primary progressive MS with clinical or radiological evidence of spinal cord involvement fulfilling revised MacDonald criteria (2010) and Lublin criteria (1996)
    2) Progression of the EDSS of at least 0.5 point during the past two years
    3) EDSS score between 4.5 and 7 (measured beside a relapse and confirmed at 6 months)
    4) Informed consent
    5) Patient aged 18-64 years
    1) Critères diagnostiques de sclérose en plaques progressive primaire ou secondaire avec signes objectifs cliniques ou radiologiques de lésion médullaire conformément aux critères de Mac Donald (2010) et aux critères de Lublin (1996)
    2) Progression du score EDSS d'au moins 0.5 point au cours des deux dernières années
    3) Score EDSS entre 4.5 et 7 (mesuré en dehors d'une poussée et confirmé à 6 mois)
    4) Consentement éclairé
    5) Patient majeur de moins de 65 ans
    E.4Principal exclusion criteria
    1) Any general chronic handicapping disease other than MS
    2) Intensive physical therapy program within the 3 months prior to inclusion
    3) Differences of the TW25 mean score between screening and baseline above 20%
    4) New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine
    5) Pregnancy or childbearing potential woman without contraception
    1) Toute maladie chronique invalidante autre que la sclérose en plaques
    2) Programme de réeducation fonctionnelle intensif dans les 3 mois précédant l'inclusion
    3) Différence de score moyen au TW25 entre la sélection et l'inclusion de plus de 20%
    4) Nouveau traitement introduit dans les 3 mois précédant l'inclusion, dans le mois précédant pour la fampridine
    5) Grossesse ou femme en âge de procréer sans contraception
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with decreased EDSS at M12 (defined as a decrease of at least 0.5 point if initial EDSS between 6 and 7 and a decrease of at least 1 point if initial EDSS between 4.5 and 5.5)
    Or
    with improved TW25 of at least 20% compared to baseline (TW25 performed two times at each visit and calculation of the average of the two values)
    Proportion de patients ayant à 12 mois :
    - une amélioration de l'EDSS (définie par une diminution d'au moins 0.5 point si l'EDSS initial est entre 6 et 7, et d'au moins 1 point si l'EDSS initial est entre 4.5 et 5.5)
    OU
    - une amélioration du TW25 d'au moins 20% (moyenne des deux mesures réalisées à chaque visite)
    E.5.1.1Timepoint(s) of evaluation of this end point
    M-1 selection visit
    M0 inclusion visit
    M3 follow up visit
    M6 follow up visit
    M9 follow up visit
    M12 end of double blind period (primary endpoint)
    M18 follow up visit
    M24 end of open label period (secondary endpoints)
    M-1 Visite de sélection
    M0 visite d'inclusion
    M3 visite de suivi
    M6 visite de suivi
    M9 visite de suivi
    M12 fin de période en double aveugle (critère principal de jugement)
    M18 visite de suivi
    M24 fin de période en ouvert (critères secondaires de jugement)
    E.5.2Secondary end point(s)
    - Proportion of patients with increased EDSS score of at least 0.5 at M12 (or M24 during the extension phase)
    - Proportion of patients with stable EDSS score at 12 months (M24 during the extension phase)
    - Mean change of the Nine Hole Peg Test (9HPT) between M0 and M12 (and between M12 and M24 during the extension phase)
    - Mean change in the SF36 score between M0 and M12 (and between M12 and M24 during the extension phase)
    - Mean change in the MS walking scale (MSWS) between M0 and M12 (and between M12 and M24 during the extension phase)
    - Mean change in the FIS (Fatigue Impact Scale) between M0 and M12 (and between M12 and M24 during the extension phase)
    - Proportion de patients avec augmentation du score EDSS d'au moins 0.5 point à M12 (ou à M24 pour la période d'extension en ouvert)
    - Proportion de patients avec score EDSS stable à M12 (ou à M24 pour la période d'extension en ouvert)
    - Différence moyenne de 9-HPT (Hole Peg Test) entre M0 et M12 (entre M12 et M24 pendant la phase d'extension)
    - Différence moyenne de SF36 entre M0 et M12 (entre M12 et M24 pendant la phase d'extension)
    - Différence moyenne de MSWS (MS walking scale) entre M0 et M12 (entre M12 et M24 pendant la phase d'extension)
    - Différence moyenne de FIS (Fatigue Impact Scale) entre M0 et M12 (entre M12 et M24 pendant la phase d'extension)
    E.5.2.1Timepoint(s) of evaluation of this end point
    M-1 selection visit
    M0 inclusion visit
    M3 follow up visit
    M6 follow up visit
    M9 follow up visit
    M12 end of double blind period (primary endpoint)
    M18 follow up visit
    M24 end of open label period (secondary endpoints)
    M-1 Visite de sélection
    M0 visite d'inclusion
    M3 visite de suivi
    M6 visite de suivi
    M9 visite de suivi
    M12 fin de période en double aveugle (critère principal de jugement)
    M18 visite de suivi
    M24 fin de période en ouvert (critères secondaires de jugement)
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned16
    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
    Last patient last visit
    Dernier patient dernière visite
    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 months6
    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: 105
    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 state105
    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
    Aucun
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-04
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