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    Summary
    EudraCT Number:2012-005076-34
    Sponsor's Protocol Code Number:BEL-FMP-12-10325
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-14
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-005076-34
    A.3Full title of the trial
    Prolonged-release oral Fampridine in Multiple Sclerosis: effects on clinical, neurophysiological and quantified gait analysis parameters.
    A cross-over, double-blinded, placebo-controlled study.
    Fampridine à liberation prolongée dans la sclérose en plaque: les effets sur les paramètres cliniques, neurophysiologiques et de l’analyse quantifiée de la marche.
    Une étude en cross-over et double aveugle, contrôlée par placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prolonged-release oral Fampridine in Multiple Sclerosis: effects on clinical, neurophysiological and quantified gait analysis parameters.
    A cross-over, double-blinded, placebo-controlled study.
    Fampridine à liberation prolongée dans la sclérose en plaque: les effets sur les paramètres cliniques, neurophysiologiques et de l’analyse quantifiée de la marche.
    Une étude en cross-over et double aveugle, contrôlée par placebo.
    A.4.1Sponsor's protocol code numberBEL-FMP-12-10325
    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 SponsorCliniques Universitaires Saint-Luc, Neurologie
    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 supportBiogen Idec Research Limited
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCliniques Universitaires Saint-Luc, Neurologie
    B.5.2Functional name of contact pointSouraya ElSankari
    B.5.3 Address:
    B.5.3.1Street AddressAvenue Hippocrate 10
    B.5.3.2Town/ cityBruxelles
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number003227641932
    B.5.5Fax number003227643679
    B.5.6E-mailsouraya.elsankari@uclouvain.be
    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 Fampyra
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Research Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameFampridine
    D.3.2Product code BIIB041
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Multiple Sclerosis
    Sclérose en Plaques
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Sclérose en Plaques
    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
    The primary objective of the study is to assess the effect of treatment with prolonged-release fampridine 10 mg twice, on the quantified gait analysis parameters (kinematics, dynamics, mechanical work).
    L'objectif principal de cette étude est d'évaluer les effets du traitement par Fampridine libération prolongée (10 mg fois 2 par jour) sur les paramètres cinématiques, dynamiques et de travail mécanique, en analyse quantifiée de marche.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are the followings:
    -quantified gait analysis by electromyographic activity and energy cost
    -clinical efficacy on strength, spasticity, walking tests, subjective self assessed walking functional parameters, quality of life, and fatigue
    -amplitude and latency of motor evoked potentials
    Les objectifs secondaires évalués seront les suivants:
    -les paramètres électromyographiques et en coût énergétique en analyse quantifiée de marche
    -efficacité clinique sur la force motrice, la spasticité, les tests de marche, les auto-évaluations fonctionnelles, de fatigue, et de qualité de vie
    -l'amplitude et la latence des potentiels évoqués moteurs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria:
    1.aged > 18 years and < 65 years
    2.diagnosed with clinically definite MS (RR, SP or PP form)
    3.have an EDSS score ≤ 6.0
    4.present a subjective complaint of impaired walking ability.

    After 4 weeks of treatment, patients who respond to treatment with Fampridine (clinical response is based on improvement of walking ability and self assessed walking capacity) will be randomized into one of the groups (active drug or placebo)
    Les patients inclus doivent répondre aux critères d'inclusion suivants:
    1-âge > 18 ans et < 65 ans
    2-diagnostic de Sclérose en Plaques cliniquement définie, de forme rémittente, secondairement progressive ou primaire progressive
    3-score EDSS ≤ 6.0
    4- plainte subjective de troubles de la marche

    Après 4 semaines de traitement, seuls les patients répondeurs (amélioration significative de la marche et de l'auto-évaluation des capacités de marche) seront randomisés en l'un des 2 groupes (placebo ou Fampridine)
    E.4Principal exclusion criteria
    Candidates will be excluded from study entry if any of the following exclusion criteria are met at the screening visit or at any time during the screening period:
    1. Presence of gait or walking disability not attributed to MS
    2. EDSS score > 6.0
    3. Relapse or steroid treatment within the last 4 weeks before inclusion
    4. Any history of seizure, epilepsy or other convulsive disorder with the exception of febrile seizures in childhood.
    5. Mild, moderate or severe renal impairment
    6. Contraindication to Motor Evoked Potentials
    7. Incapacity to walk on a treadmill at a comfortable speed during at least 3 minutes
    8. Concurrent treatment with other medicinal products containing 4-aminopyridine
    9. Concomitant use of medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2) for example, cimetidine.
    10. Breastfeeding or pregnant female subjects or subjects who are considering becoming pregnant.
    Les sujets seront exclus en cas de présence de l'un des critères suivants au screening ou pendant la période d'inclusion:
    1-présence de troubles de la marche d'une autre origine que la Sclérose en Plaques
    2-score EDSS > 6.0
    3- poussée ou traitement par corticoïdes dans les 4 semaines précédant l'inclusion
    4-antécédent d'épilepsie ou de convulsions, excepté les convulsions fébriles dans l'enfance
    5-insuffisance renale légère, modérée ou sévère
    6-contreindication aux potentiels évoqués moteurs
    7-impossibilité de marcher sur un tapis de marche à vitesse confortable pendant au moins 3 minutes
    8-traitement concomittant à base de 4 aminopyridine
    9-traitement concomitant par inhibiteurs de transporteurs organiques de cation, par exemple la cimétidine
    10- femmes enceintes, planifiant une grossesse, ou allaitant.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the quantified gait analysis kinematic, dynamic and mechanical work parameters
    Amélioration après traitement, des paramètres cinématiques, dynamiques et de travail mécanique, en analyse quantifiée de marche
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each patient will be randomized, after inclusion, in group 1 or 2. Group 1 will receive the treatment during 6 weeks, then have a period of 2 weeks of wash-out, and after this be treated with placebo for 6 weeks.
    Group 2 will receive the placebo first for 6 weeks, be washed-out for 2 weeks, and then have the IMP for 6 weeks.

    Each patient will thus be evaluated 4 times, before and at the end of each period of treatment.
    Chaque patient, à l'inclusion, sera randomisé en l'un des 2 groupes, 1 ou 2. Le groupe 1 recevra le traitement par Fampridine pendant 6 semaines, puis aura une période de 2 semaines de wash-out, avant d'être traité par placebo pendant 6 semaines.
    Le groupe 2 sera traité d'abord par placebo pendant 6 semaines, cash-out pendant 2 semaines, puis la FAmpridine pendant 6 semaines.
    Ainsi, chaque patient sera évalué 4 fois, avant et à la fin de chacune des 2 périodes de traitement.
    E.5.2Secondary end point(s)
    -comparison of change after treatment, of quantified parameters of electromyography and energy cost an gait analysis
    -comparison of clinical parameters (spasticity, strength, muscular stiffness, walking tests) and subjectives scores (MSWS-12, Borg scale, quality of life, fatigue)
    -comparison of motor evoked potentials parameters
    -comparaison après traitement des paramètres électromyographiques et de coût énergétique, en analyse quantifiée de marche
    -comparaison après traitement des paramètres cliniques (spasticité, force musculaire, raideur musculaire), et des échelles subjectives (MSWS-12, score de Borg, qualité de vie, fatigue)
    -comparaison des résultats des potentiels évoqués moteurs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each patient will thus be evaluated 4 times, before and at the end of each period of treatment.
    These evaluations will be coupled with the primary endpoint evaluations.
    chaque patient sera évalué 4 fois, avant et à la fin de chacune des 2 périodes de traitement.
    Ces analyses seront couplées aux évaluations des objectifs primaires
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    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
    Physiologic mechanisms of Fampridine efficacy on walking abilities in MS patients.
    Comprendre les mécanismes physiopathologiques sous-tendant l'efficacité de la Fampridine sur la marche des patients atteints de 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) 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 No
    E.8.1.6Cross over Yes
    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 trial2
    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
    Dernière visite chez le dernier patient inclus
    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 months2
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 110
    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 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 state110
    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)
    From the 110 screened patients, only responders will pursue the study. According to available data from previous studies, 30% of patients will respond.
    We intend to randomize 32 patients into the 2 arms of treatment (placebo before FAmpyra vs Fampyra before placebo) for the 14 weeks of the study.
    At the end of this study, if the treatment is not yet available for commercial use, the sponsor intends to sponsor an extension study to provide treatment to responding patients wishing to continue.
    110 patients seront inclus, parmi eux, seuls les répondeurs (30% selon les études antérieures) seront randomisés. Donc 32 patients seront répartis entre les 2 bras de traitement (placebo puis Fampridine ou inversement) pour les 14 semaines de l'étude.
    A la fin de cette étude, si la Fampridine n'est pas encore commercialisée en Belgique, le sponsor a prévu un protocole d'extension, afin d'offrir le traitement aux patients répondeurs qui le souhaitent.
    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 Decision2013-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-29
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