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    Summary
    EudraCT Number:2012-003056-36
    Sponsor's Protocol Code Number:CBAF312A2304
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-10-02
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-003056-36
    A.3Full title of the trial
    A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis
    Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo, con duración variable del tratamiento, que evalúa la eficacia y seguridad de Siponimod (BAF312) en pacientes con esclerosis múltiple secundaria progresiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis
    Estudio de eficacia, seguridad y tolerabilidad para BAF312 en pacientes con esclerosis múltiple secundaria progresiva
    A.4.1Sponsor's protocol code numberCBAF312A2304
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/115/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica S.A
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNA
    B.5.2Functional name of contact pointNA
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountrySpain
    B.5.4Telephone number0034 93 306 43 42
    B.5.5Fax number0034 93 306 42 90
    B.5.6E-maileecc.novartis@novartis.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 nameSiponimod 2 mg tablet
    D.3.2Product code BAF312A
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSiponimod
    D.3.9.1CAS number 1234627-85-0
    D.3.9.2Current sponsor codeBAF312
    D.3.9.3Other descriptive nameBAF312 hemifumarate
    D.3.9.4EV Substance CodeSUB31412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 2
    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 nameSiponimod 1 mg tablet
    D.3.2Product code BAF312A
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSiponimod
    D.3.9.1CAS number 1234627-85-0
    D.3.9.2Current sponsor codeBAF312
    D.3.9.3Other descriptive nameBAF312 hemifumarate
    D.3.9.4EV Substance CodeSUB31412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 3
    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 nameSiponimod 0.5 mg tablet
    D.3.2Product code BAF312A
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSiponimod
    D.3.9.1CAS number 1234627-85-0
    D.3.9.2Current sponsor codeBAF312
    D.3.9.3Other descriptive nameBAF312 hemifumarate
    D.3.9.4EV Substance CodeSUB31412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.IMP: 4
    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 nameSiponimod 0.25 mg tablet
    D.3.2Product code BAF312A
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSiponimod
    D.3.9.1CAS number 1234627-85-0
    D.3.9.2Current sponsor codeBAF312
    D.3.9.3Other descriptive nameBAF312 hemifumarate
    D.3.9.4EV Substance CodeSUB31412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 placeboFilm-coated tablet
    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
    Secondary progressive multiple sclerosis
    Esclerosis Múltiple Secundaria Progresiva
    E.1.1.1Medical condition in easily understood language
    Secondary progressive multiple sclerosis
    Esclerosis Múltiple Secundaria Progresiva
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive 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
    Primary objective: To demonstrate the efficacy of Siponimod (BAF312) relative to placebo in delaying the time to 3-month confirmed disability progression in patients with secondary progressive multiple sclerosis (SPMS) as measured by expanded disability status scale (EDSS)
    El objetivo principal es demostrar la eficacia de BAF312 respecto al placebo para retrasar el tiempo hasta la progresión de la discapacidad confirmada a 3 meses en pacientes con EMSP medida mediante la EDSS.
    E.2.2Secondary objectives of the trial
    First key secondary objective: To demonstrate the efficacy of Siponimod relative to placebo in delaying the time to 3-month confirmed worsening of at least 20% from Baseline in the timed 25-foot walk test (T25W)
    Second key secondary objective: To demonstrate the efficacy of Siponimod relative to placebo in reducing the increase in T2 lesion volume from Baseline to the end of the study

    For further secondary objectives please see protocol
    El primer objetivo secundario clave es demostrar la eficacia de BAF312 respecto al placebo para retrasar el tiempo hasta un empeoramiento confirmado a 3 meses de al menos un 20% respecto a la Visita basal en la marcha cronometrada de 7,62 metros (25 pies) (T25W).
    El segundo objetivo secundario clave es demostrar la eficacia de BAF312 respecto al placebo para reducir el aumento en el volumen de lesiones en T2 desde la Visita basal hasta el final del estudio.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Exploratory blood and CSF biomarker sub-study
    (2012-7-12, Version 00)
    - Characterization of changes in biomarker levels in the CSF and peripheral blood during study course
    2. Exploratory cognitive sub-study
    (2012-7-12, Version 00)
    - Exploration of cognitive impairment in SPMS patients
    - Investigation of relationship between cognitive test performance and certain brain imaging findings
    3. Exploratory optical coherence tomography (OCT) sub-study
    (2012-7-12, Version 00)
    -Exploration of the utility of retinal layer thickness as a marker of axonal degeneration and disability progression in SPMS
    4. Magnetic resonance imaging (MRI) sub-study
    (2012-07-12, Version 00)
    -Exploration of the use of MRI techniques that may provide additional information about the extent and nature of structural damage due to demyelination or axonal loss, in patients with SPMS treated with Siponimod and placebo, respectively
    -In addition to the conventional MRI, MTR (magnetization transfer ratio) and high resolution structural imaging will be implemented at centers meeting pre-specified technical requirements to evaluate structural integrity of the brain lesions visible on conventional MRI and in the normal appearing brain tissue as well as the grey matter volume of the patients participating in the CBAF312A2304 study
    5. Exploratory fluorescence-activated cell sorting (FACS) sub-study
    (2012-07-12, Version 00)
    -Investigation of the influence of pre-treatment peripheral lymphocyte composition on the on-treatment absolute lymphocyte count (ALC)
    -Increase understanding of the effect of Siponimod on different lymphocyte subpopulations, follow their longitudinal changes on treatment and relate these changes to the clinical and MR outcomes
    1. Subestudio de biomarcadores exploratorios en sangre y en LCR. (2012-7-12, Version 00)
    - Caracterizar los cambios en la concentración de biomarcadores en LCR y en sangre periférica durante el estudio.
    2. Subestudio exploratorio cognitivo. (2012-7-12, Version 00)
    - Explorar el deterioro cognitivo en pacientes con EMSP e investigar la relación entre la ejecución de la prueba cognitiva y ciertos hallazgos de imagen cerebral.
    3. Subestudio exploratorio de OCT. (2012-7-12, Version 00)
    - Explorar la utilidad del grosor de las capas retinianas como marcador de degeneración axónica y progresión de la incapacidad en la EMSP
    4. Subestudio de RM. (2012-07-12, Version 00)
    -Explorar el empleo de las técnicas de RM que pueden proporcionar información adicional sobre la extensión y la naturaleza del daño estructural debido a desmielinización o a pérdida axónica, en pacientes con EMSP tratados con BAF312 y placebo, respectivamente. Además de la RM convencional, se implementará el MTR y las pruebas de imagen estructural de alta resolución en centros que cumplan los requisitos técnicos pre-especificados para evaluar la integridad estructural de las lesiones cerebrales visibles en la RM convencional y en el tejido cerebral de aspecto normal así como el volumen de sustancia gris en los pacientes que participan en el estudio CBAF312A2304.
    5. Subestudio exploratorio FACS. (2012-07-12, Version 00)
    - Investigar la influencia de la composición de linfocitos periféricos pre-tratamiento sobre el ALC durante el tratamiento y obtener una mejor comprensión del efecto de BAF312 en las diferentes subpoblaciones de linfocitos, seguir sus cambios longitudinales sobre el tratamiento y relacionar estos cambios con los resultados clínicos y de RM.
    E.3Principal inclusion criteria
    Prior history of relapsing remitting MS

    Secondary progressive multiple sclerosis (SPMS) defined as progressive increase of disability in at least 6 months

    EDSS score of 3.0 to 6.5

    No relapse or corticosteroid treatment within 3 months

    Other protocol-defined inclusion criteria may apply
    -Antecedentes previos de EM remitente recurrente (EMRR) de acuerdo con los criterios revisados de McDonald 2010 (Polman et al. 2011)
    -Curso secundariamente progresivo de la EM (EMSP), definido como un aumento progresivo de la discapacidad de al menos 6 meses de duración
    - Estado de discapacidad en la Selección con una puntuación EDSS de 3,0 a 6,5 (ambas inclusive)
    - Ninguna evidencia de recidiva o tratamiento con corticoesteroides en los 3 meses previos a la aleatorización

    Ver apartado criterios de inclusión del protocolo para el resto de criterios.
    E.4Principal exclusion criteria
    Women of child bearing potential must use reliable forms of contraception.

    Diagnosis of Macular edema during screening period

    Any medically unstable condition determined by investigator

    Unable to undergo MRI scans

    Hypersensitivity to any study drugs or drugs of similar class

    Other protocol-defined inclusion criteria may apply
    -Mujeres embarazadas o en período de lactancia deben utilizar métodos anticonceptivos altamente eficaces.
    -Diagnóstico de edema macular durante la fase de prealeatorización
    -Pacientes con alguna enfermedad inestable, según lo determine el investigador
    -Pacientes que no puedan ser sometidos a exploraciones con RM
    -Antecedentes de hipersensibilidad a cualquiera de las medicaciones del estudio o a fármacos de clases químicas similares
    Ver apartado criterios de exclusión del protocolo para el resto de criterios.
    E.5 End points
    E.5.1Primary end point(s)
    The delay in time to 3-month confirmed disability progression by Siponimod (BAF312) relative to placebo as measured by expanded disability status scale (EDSS)

    Confirmed disability is defined as an increase of score of 1 point in patients with baseline score of 3.0-5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.
    Eficacia de BAF312 respecto al placebo para retrasar el tiempo hasta la progresión de la discapacidad confirmada a 3 meses medida mediante la EDSS.

    La progresión de la discapacidad se define como un incremento en 1 punto en pacientes con una puntuación basal entre 3.0 y 5.0 y un incremento de 0,5 puntos en pacientes con una puntuación basal entre 5.5 y 6.5.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline, every three months
    basal, cada 3 meses
    E.5.2Secondary end point(s)
    The first key secondary endpoint is the delay in time to 3-month confirmed worsening of at least 20% from Baseline in the timed 25-foot walk test (T25W) by Siponimod (BAF312) compared to placebo.

    The second key secondary endpoint is the efficacy of Siponimod (BAF312) relative to placebo in reducing the increase in T2 lesion volume from Baseline to the end of the study.
    El primer objetivo secundario clave es demostrar la eficacia de BAF312 respecto al placebo para retrasar el tiempo hasta un empeoramiento confirmado a 3 meses de al menos un 20% respecto a la Visita basal en la marcha cronometrada de 7,62 metros (25 pies) (T25W).
    El segundo objetivo secundario clave es demostrar la eficacia de BAF312 respecto al placebo para reducir el aumento en el volumen de lesiones en T2 desde la Visita basal hasta el final del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.) baseline, every three months
    2.) baseline, every year
    1.) Basal, cada 3 meses
    2.) basal, cada año
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA173
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Egypt
    Estonia
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Latvia
    Lithuania
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Última visita último paciente
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 1530
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1031
    F.4.2.2In the whole clinical trial 1530
    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)
    Patients who complete the double-blind treatment epoch will be offered to enter a planned Phase III extension study, until the drug is available on the market for treatment of SPMS or development is discontinued. Patients who have completed the ?Abbreviated Visits? and patients who have completed the study on open-label treatment may also be eligible for inclusion in the planned Phase III extension study.
    Los pacientes que completen el estudio podrán ser elegibles para la inclusión en el estudio de extensión de Fase III planificado hasta que el fármaco esté disponible en el mercado para EMSP o se pare el desarrollo. Los pacientes que completen las ?visitas abreviadas? y los pacientes que completen el estudio en tratamiento abierto también serán elegibles para ser incluidos en el estudio de extensión de Fase III planificado.
    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 Decision2012-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-20
    P. End of Trial
    P.End of Trial StatusOngoing
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