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    Summary
    EudraCT Number:2011-005677-23
    Sponsor's Protocol Code Number:CFTY720D2311
    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:2013-04-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-005677-23
    A.3Full title of the trial
    A two-year, double-blind, randomized, multicenter, active controlled
    study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon β-1a i.m. once weekly in pediatric patients with multiple sclerosis
    Estudio multicéntrico, aleatorizado, doble ciego, con control activo, de dos años de duración para evaluar la seguridad y la eficacia de fingolimod administrado por vía oral una vez al día frente a interferon β-1a i.m. administrado una vez a la semana en pacientes pediátricos con esclerosis múltiple
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis
    Seguridad y eficacia de fingolimod en pacientes pediatricos con esclerosis multiple
    A.4.1Sponsor's protocol code numberCFTY720D2311
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/272/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmaceutica 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 Service AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmaceutica S.A.
    B.5.2Functional name of contact pointDepartamento medico (ICRO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les corts catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900353036
    B.5.5Fax number+34932479903
    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 Yes
    D.2.1.1.1Trade name Gilenya
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd.
    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.3.2Product code FTY720
    D.3.4Pharmaceutical form Capsule, hard
    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 INNfingolimod
    D.3.9.1CAS number 162359-56-0
    D.3.9.2Current sponsor codeFTY720
    D.3.9.3Other descriptive nameFINGOLIMOD HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB30967
    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: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Avonex
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Ltd.
    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.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNinterferon beta-1a
    D.3.9.1CAS number 220581-49-7
    D.3.9.3Other descriptive nameINTERFERON BETA-1A
    D.3.9.4EV Substance CodeSUB12440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 namefingolimod
    D.3.2Product code FTY720
    D.3.4Pharmaceutical form Capsule, hard
    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 INNfingolimod
    D.3.9.1CAS number 162359-56-0
    D.3.9.2Current sponsor codeFTY720
    D.3.9.3Other descriptive nameFINGOLIMOD HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB30967
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solution for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing multiple sclerosis
    Esclerosis multiple remitente recurrente
    E.1.1.1Medical condition in easily understood language
    relapsing multiple sclerosis
    Esclerosis multiple remitente recurrente
    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 10048393
    E.1.2Term Multiple sclerosis relapse
    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
    To evaluate the efficacy of fingolimod relative to intramuscular IFN β-1a in reducing the frequency of relapses as assessed by the annualized relapse rate in children/adolescent MS patients aged 10 to less than 18 years treated for up to 24 months.
    Evaluar la eficacia de fingolimod con respecto a IFN ß-1a intramuscular en la reducción de la frecuencia de recidivas según la evaluación de la tasa anual de recidivas en pacientes niños/adolescentes con EM con edades comprendidas entre los 10 y los 17 años (ambos inclusive) tratados hasta un máximo de 24 meses.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of fingolimod relative to IFN β-1a in reducing the number of new/newly enlarging T2 (n/neT2) lesions in children/adolescent MS patients aged 10 to less than 18 years treated for up to 24 months.
    Other secondary objectives
    • To evaluate the safety of fingolimod relative to IFN β-1a in children/adolescent MS patients.
    • To evaluate the effect of fingolimod relative to IFN β-1a in children/adolescent MS patients on other relapse-related parameters:
    o Time to first relapse
    o Proportion of patients relapse-free
    • To evaluate the effect of fingolimod relative to IFN β-1a in children/adolescent MS patients on T1 Gd-enhancing lesions on brain MRI.
    • To study the pharmacokinetics of fingolimod and fingolimod-P in children/adolescent MS patients treated for up to 24 months.
    • To study the pharmacokinetic/pharmacodynamic relationship for key efficacy and safety outcomes in children/adolescent MS patients treated for up to 24 months.
    Evaluar la eficacia de fingolimod con respecto a IFN ß-1a en la reducción del número de lesiones de nueva aparición/ lesiones que se han extendido en T2 (n/eT2) en pacientes niños/adolescentes con EM con edades entre 10 y 17 años (ambos inclusive) tratados hasta 24 meses.
    Evaluar la seguridad de fingolimod con respecto a IFN ß-1a en pacientes niños/adolescentes con EM.
    Evaluar el efecto de fingolimod con respecto a IFN ß-1a en pacientes niños/adolescentes con EM en otros parámetros relacionados con la recidiva:
    o Tiempo hasta la primera recidiva
    o pacientes sin recidiva
    Evaluar el efecto de fingolimod con respecto a IFN ß-1a en pacientes niños/adolescentes con EM en lesiones realzadas con Gd en T1 en RM cerebrales
    Estudiar farmacocinética de fingolimod y fingolimod-P en pacientes niños/adolescentes con EM tratados hasta 24 meses.
    Estudiar relación farmacocinética/farmacodinámica en resultados de eficacia y seguridad en pacientes niños/adolescentes con EM tratados hasta 24 meses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained before any assessment is performed.
    2. Male and female patients aged 10-17 years old, inclusive (i.e., have not yet had their 18th birthday) at randomization.
    3. A diagnosis of MS as defined by the consensus definition proposed for pediatric MS (Krupp et al 2007, Polman et al 2011).
    - Central review of the diagnosis of pediatric MS will be required for all patients prior to randomization.
    4. At least one MS relapse during the previous year or two MS relapses in the previous two years, preceding enrollment to the study.
    5. Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive.
    1. Se deberá obtener el consentimiento informado por escrito antes de que se realice cualquier evaluación.
    2. Pacientes de ambos sexos con edades comprendidas entre los 10 y los 17 años (ambos inclusive) (es decir, que todavía no hayan cumplido los 18 años de edad) en la aleatorización.
    3. Diagnóstico de EM según la definición consensuada propuesta para la EM pediátrica (Krupp et al 2007, Polman et al 2011).
    - Será necesario realizar una revisión central del diagnóstico de EM pediátrica a todos los pacientes antes de la aleatorización
    4. Al menos una recidiva de EM durante el año anterior o dos recidivas de EM en los dos años anteriores a la inclusión en el estudio.
    5. Una puntuación de 0 a 5,5 (ambos inclusive) en la escala ampliada del estado de discapacidad (EDSS).
    E.4Principal exclusion criteria
    1. Patients with progressive MS.
    2. Patients with an active, chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. Sjögren’s disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency).
    3. Patients with widespread and symmetric white matter alterations in the Screening MRI suggestive of other demyelinating disorders (e.g. metabolic disorders, mitochondrial disorders).
    4. Patients meeting the definition of ADEM according to the 2007 consensus definition for pediatric MS and related disorders (Krupp et al 2007).
    5. Patients who have been previously treated with any IFN β and have detectable antibodies to IFN β at Screening.
    6. Patients treated with:
    o Systemic corticosteroids or adrenocorticotropic hormone (ACTH) in the 30 days prior to Screening
    o High dose intravenous immunoglobulin within 2 months prior to randomization
    o Natalizumab within 3 months prior to randomization
    o Immunosuppressive medications, e.g. azathioprine or methotrexate, within 6 months prior to randomization
    o Rituximab, ofatumumab or ocrelizumab within 2 years prior to randomization
    o Cladribine, cyclophosphamide or mitoxantrone at any time
    o The following antiarrhythmic drugs at Screening: Class Ia (e.g. quinidine, disopyramide) or Class III (e.g. amiodarone, sotalol) anti-arrhythmics
    o Concurrently treated with heart-rate-lowering drugs at Screening e.g.: Beta blockers, heart-rate lowering calcium channel blockers (e.g. verapamil, diltiazem or ivabradine), digoxin, anticholinesteratic agents, pilocarpine.
    Advice from a cardiologist should be sought regarding the switch to non-heartrate lowering medicinal products.
    7. Patients diagnosed with macular edema during the pre-randomization phase.
    8. Patients with active systemic bacterial, viral or fungal infections, including tuberculosis.
    9. Patients who have not completed their vaccination schedule based on the local recommendations.
    10. Patients who are negative for varicella-zoster virus, mumps, measles, or rubella IgG antibodies.
    11. Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within one month prior to randomization.
    12. Patients with a history or presence of malignancy.
    13. Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
    14. Patients with any severe cardiac disease or significant findings on the screening ECG, such as:
    o History of symptomatic bradycardia or recurrent syncope
    o Known ischaemic heart disease
    o History of major congenital heart disease
    o Cerebrovascular disease
    o History of myocardial infarction
    o Congestive heart failure
    o History of cardiac arrest
    o Uncontrolled hypertension despite prescribed medications
    o Resting heart rate <55 bpm (in patients 12 years or older) and <60 bpm (in patients below 12 years)
    o Severe untreated sleep apnea.
    o Sick sinus syndrome or sino-atrial heart block
    o QTc interval >450 msec in males and >470 msec in females or relevant risk factors for QT prolongation (e.g. hypokalaemia, mypomagnesemia, congenital QT prolongation)
    o Second degree Mobitz type II or higher AV block
    15. Patients with any pulmonary conditions, as determined by the investigator, including severe asthma defined as per the 2010 WHO uniform definition on severe asthma (Bousquet et al 2010).
    16. Positive results of screening period testing for serological markers for hepatitis A, B, C, and E indicating acute or chronic infection:
    o anti-HAV IgM
    o HBs Ag and/or anti-HBc IgM
    o anti-HCV IgG or IgM
    o anti- HEV IgM (positive IgG: do HEV-RNA PCR: if negative, patient can be included)
    17. Patients with any of the following hepatic conditions:
    o Chronic liver or biliary disease
    o Total or conjugated bilirubin >1.5 (unless in the context of Gilbert’s disease), AST (SGOT) or ALT (SGPT) > 2 times the upper limit of the normal range for age
    18. Patients with severe renal insufficiency (GFR <30 ml/min/1.73 m2).
    19. Patients with lymphocyte count < 800 cells (mm3).
    20. Patients with any of the following neurologic /psychiatric disorder:
    o History of suicide attempt or patients who, in the opinion of the investigator,
    are at risk of suicide attempt;
    o History of substance abuse (drug or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject’s ability to cooperate and comply with the study procedures;
    o Progressive neurological disorder, other than MS, which may affect participation in the study or require the use of medications not allowed by the protocol
    21. Patients unable to undergo MRI scans, including those with claustrophobia or a history of severe hypersensitivity to gadolinium-DTPA.
    ......
    please find the complete criteria in the protocol
    1. Pacientes con EM progresiva.
    2. Pacientes con una enfermedad crónica activa (o estable tratada con inmunoterapia) del sistema inmunitario que no sea EM o con un síndrome de inmunodeficiencia conocido.
    3. Pacientes con numerosas anomalías simétricas y generalizadas en la sustancia blanca observadas en la RM de selección que indican otros trastornos desmielinizantes.
    4. Pacientes que se ajusten a la definición de EAD según la definición consensuada en 2007 de EM pediátrica y trastornos relacionados (Krupp et al 2007).
    5. Pacientes que hayan sido tratados anteriormente con cualquier IFN ß y tengan anticuerpos detectables de IFN ß en la selección.
    6. Pacientes tratados con:
    o Corticosteroides sistémicos o corticotropina (ACTH) durante los 30 días anteriores a la selección
    o Una dosis elevada de inmunoglobulina intravenosa durante los 2 meses anteriores a la aleatorización
    o Natalizumab durante los 3 meses anteriores a la aleatorización
    o Medicación inmunosupresora, p. ej., azatioprina o metotrexato, durante los 6 meses anteriores a la aleatorización
    o Rituximab, ofatumumab u ocrelizumab durante los 2 años anteriores a la aleatorización
    o Cladribina, ciclofosfamida o mitoxantrona en cualquier momento
    o Los siguientes fármacos antiarrítmicos en la selección: antiarrítmicos de clase Ia o de clase III
    o Tratados de forma concomitante con fármacos que reducen la frecuencia cardíaca en la selección, digoxina, fármacos anticolinesterásicos o pilocarpina.
    7. Pacientes a quienes se les haya diagnosticado edema macular durante la fase de prealeatorizacion.
    8. Pacientes con infecciones bacterianas, víricas o fúngicas sistémicas activas, incluida la tuberculosis.
    9. Pacientes que no hayan completado su programa de vacunación basándose en las recomendaciones locales.
    10. Pacientes con anticuerpos IgG negativos del virus de la varicela zóster, paperas, sarampión o rubeola.
    11. Pacientes que hayan recibido cualquier vacuna viva o viva atenuada (incluida la del virus de la varicela zóster o del sarampión) durante el mes anterior a la aleatorización.
    12. Pacientes con antecedentes o presencia de cáncer.
    13. Pacientes con cualquier enfermedad médicamente inestable, según la evaluación del médico que les trate en cada centro.
    14. Pacientes con cualquier enfermedad cardíaca grave o hallazgos significativos en el ECG de selección:
    o Antecedentes de bradicardia sintomática o síncope recurrente
    o Cardiopatía isquémica conocida
    o Antecedentes de cardiopatía congénita significativa
    o Enfermedad cerebrovascular
    o Antecedentes de infarto de miocardio
    o Insuficiencia cardíaca congestiva
    o Antecedentes de paro cardiaco
    o Hipertensión no controlada a pesar de la medicación prescrita
    o Frecuencia cardíaca en reposo <55 lpm (en pacientes ≥12 años de edad) y <60 lpm (en pacientes < 12 años de edad)
    o Apnea del sueño grave no tratada
    o Síndrome de disfunción sinusal o bloqueo cardiaco sinoauricular
    o Intervalo QTc >450 mseg en hombres y >470 mseg en mujeres o factores de riesgo relevantes de prolongación del QT
    o Bloqueo AV de segundo grado Mobitz tipo II o superior
    15.Pacientes con cualquier enfermedad pulmonar, incluido el asma grave.
    16. Resultados positivos en las pruebas del periodo de selección para marcadores serológicos de hepatitis A, B, C y E que indican una infección aguda o crónica:
    o IgM anti-VHA
    o AgHBs y/o IgM anti-HBc
    o IgG o IgM anti-VHC
    o IgM anti-VHE
    17. Pacientes con cualquiera de las siguientes enfermedades hepáticas:
    o Enfermedad hepática crónica o biliar
    o Bilirrubina total o conjugada >1,5 (excepto en el contexto de la enfermedad de Gilbert), AST (SGOT) o ALT (SGPT) > 2 veces por encima del límite superior normal para su edad
    18. Pacientes con insuficiencia renal grave (TFG < 30 ml/min/1,73m2).
    19. Pacientes con un recuento de linfocitos < 800 células (mm3).
    20. Pacientes con trastornos neurológicos / psiquiátricos:
    o Antecedentes de tentativa de suicidio o pacientes que tienen riesgo de suicidio.
    o Antecedentes de toxicomanía (drogas o alcohol) o cualquier otro factor (una enfermedad psiquiátrica grave) que pueda interferir en la capacidad del sujeto para cooperar y cumplir los procedimientos del estudio.
    o trastorno neurológico progresivo, salvo EM, que pueda afectar a la participación en el estudio
    21. Pacientes que no puedan someterse a RM, aquellos con claustrofobia o antecedentes de hipersensibilidad grave al gadolinio-DTPA.
    22. Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el estado de la mujer después de la concepción y hasta que finalice la gestación, confirmado por un resultado positivo en la prueba HCG (> 5 mUI/ml).
    23. Pacientes en edad fértil,todas las mujeres fisiológicamente capaces de quedarse embarazadas, salvo que opten por la abstinencia o, si son sexualmente activas, por utilizar un método anticonceptivo.
    24.hipersensibilidad a alguno de los fármacos del estudio o a fármacos de clases químicas similares.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of fingolimod relative to intramuscular interferon B-1a in reducing the frequency of relapses as assess by the annualized relapse rate (ARR) in children/adolescent MS patients aged 10 to less than 18 years treated for up to 24 months.
    Evaluar la eficacia de fingolimod con respecto a IFN ß-1a intramuscular en la reducción de la frecuencia de recidivas según la evaluación de la tasa anual de recidivas en pacientes niños/adolescentes con EM con edades comprendidas entre los 10 y los 17 años (ambos inclusive) tratados hasta un máximo de 24 meses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 meses
    E.5.2Secondary end point(s)
    To evaluate the efficacy of fingolimode relative to IFN B-1a in reducing the number of new/newly enlarging T2 (n/ne T2)lesions in children/adolescent MS patients aged 10 to less than 18 years treated for up to 24 months
    Evaluar la eficacia de fingolimod con respecto a IFN ß-1a en la reducción del número de lesiones de nueva aparición/ lesiones que se han extendido en T2 (n/eT2) en pacientes niños/adolescentes con EM con edades comprendidas entre los 10 y los 17 años (ambos inclusive) tratados hasta un máximo de 24 meses.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 meses
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Brazil
    Canada
    Mexico
    United States
    Venezuela, Bolivarian Republic of
    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 years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 190
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 38
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 152
    F.1.2Adults (18-64 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-04-09. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minor patients aged 10 to less than 18 years : parents or guardian must give their written consent.
    Pacientes de 10 años y menores de 18 años: padres o tutores deben dar su consentimiento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 190
    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)
    An extension study will be offered
    Un estudio de extensión será ofrecido.
    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 Decision2013-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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