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    Summary
    EudraCT Number:2011-005249-12
    Sponsor's Protocol Code Number:EFC11759
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-01
    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 number2011-005249-12
    A.3Full title of the trial
    A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis
    Ensayo multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y dos años de duración para evaluar la eficacia, seguridad, tolerabilidad y la farmacocinética de teriflunomida administrada por vía oral una vez al día en pacientes pediátricos con formas recurrentes de esclerosis múltiple
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis
    Estudio de dos años de duración, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia, seguridad, tolerabilidad y la farmacocinética de teriflunomida administrada una vez al día en pacientes pediátricos con formas recurrentes de esclerosis múltiple
    A.3.2Name or abbreviated title of the trial where available
    TERIKIDS
    TERIKIDS
    A.4.1Sponsor's protocol code numberEFC11759
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1124-0983
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/209/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGenzyme Corporation
    B.1.3.4CountryUnited States
    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 supportGenzyme Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.5Fax numberNA
    B.5.6E-mailES-unidadestudiosclinicos@sanofi.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 nameTeriflunomide
    D.3.2Product code HMR1726
    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 INNTERIFLUNOMIDE
    D.3.9.1CAS number 108605-62-5
    D.3.9.4EV Substance CodeSUB25218
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14
    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 nameTeriflunomide
    D.3.2Product code HMR1726
    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 INNTERIFLUNOMIDE
    D.3.9.1CAS number 108605-62-5
    D.3.9.4EV Substance CodeSUB25218
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    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 nameTeriflunomide
    D.3.2Product code HMR1726
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNTERIFLUNOMIDE
    D.3.9.1CAS number 108605-62-5
    D.3.9.4EV Substance CodeSUB25218
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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.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
    Multiple Sclerosis
    Esclerosis Múltiple
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Esclerosis Múltiple
    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 16.1
    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
    To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis.
    Evaluar el efecto de teriflunomida en comparación con placebo sobre la actividad de la enfermedad medida a través del tiempo transcurrido hasta la primera recidiva clínica posterior a la aleatorización en niños y adolescentes de 10 a 17 años de edad con formas recurrentes de esclerosis múltiple.
    E.2.2Secondary objectives of the trial
    To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain MRI and on cognitive function.
    To evaluate the safety and tolerability of teriflunomide in comparison to placebo.
    To evaluate the pharmacokinetics (PK) of teriflunomide.
    - Evaluar el efecto de teriflunomida en comparación con placebo sobre la actividad/progresión de la enfermedad medidas mediante RMN del cerebro y sobre la función cognitiva.
    - Evaluar la seguridad y la tolerabilidad de teriflunomida en comparación con placebo.
    - Evaluar la farmacocinética (FC) de teriflunomida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with relapsing multiple sclerosis (MS) based on McDonald criteria of 2010 and International Pediatric Multiple Sclerosis Study Group (IPMSG) criteria for pediatric MS:
    -at least one relapse in the 12 months preceding randomization, or
    -at least 2 relapses in the 24 months preceding randomization.
    - Equal or less than 17 years of age and equal or greater than 10 years of age at randomization.
    - Signed informed consent/assent obtained from patient and patient's legal representative.
    Pacientes con diagnóstico de EM recurrente basado en los criterios para la EM pediátrica de McDonald de 2010 y del Grupo de Estudio Internacional de la Esclerosis Múltiple Pediátrica y que reúnan estos requisitos:
    - al menos 1 recidiva en los 12 meses previos a la aleatorización; o
    - al menos 2 recidivas en los 24 meses previos a la aleatorización.
    ?17 años y ?10 años en el momento de la aleatorización.
    Obtención del consentimiento informado firmado/asentimiento del paciente y de su representante legal (padres o tutores) según la normativa local.
    E.4Principal exclusion criteria
    - Expanded disability status scale (EDSS) score greater than 5.5 at screening or randomization visit.
    - Relapse within 30 days prior to randomization.
    - Treated with cladribine or mitoxantrone within 2 years preceding randomization.
    - Treated with glatiramer acetate, interferons, natalizumab, introvenous immunoglobulins or other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, dimetthyl fumrate, fingolimod less than 3 months or five half-lives prior to randomization, whichever is greater.
    - History of human immunodeficiency virus (HIV) infection.
    - Contraindication for magnetic resonance imaging (MRI).
    - Pregnant or breast-feeding females or those who plan to become pregnant during the study.
    - Female patients of child-bearing potential not using highly effective contraceptives or (double barrier) contraceptive method.
    Puntuación en la Escala ampliada del estado de discapacidad (Expanded Disability Status Scale, EDSS) >5,5 en las visitas de selección o de aleatorización.
    Recidiva en los 30 días anteriores a la aleatorización.
    Haber recibido tratamiento con cladribina o mitoxantrona en los 2 años previos a la aleatorización.
    Haber recibido tratamiento con acetato de glatirámero, interferones, natalizumab, inmunoglobulinas intravenosas u otros inmunosupresores o inmunomoduladores como ciclofosfamida, azatioprina, ciclosporina, metotrexato, micofenolato, dimetilfumarato o fingolimod menos de 3 meses o de 5 vidas medias antes de la aleatorización, el período más largo.
    Antecedentes de infección por VIH.
    Contraindicación para RMN.
    Mujeres embarazadas o que estén en período de lactancia o que tengan previsto quedarse embarazadas durante el estudio.
    Mujeres en edad fértil que no utilicen anticonceptivos o un método anticonceptivo (doble barrera) altamente eficaz.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first clinical relapse after randomization
    Tiempo transcurrido hasta la primera recidiva clínica después de la aleatorización.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over 96 weeks
    Hasta 96 semanas
    E.5.2Secondary end point(s)
    1 - Proportion of relapse free patients
    2 - Number of of new/newly enlarged T2 lesions
    3 - Number of T1 Gd-enhancing T1 lesions
    4 - Change in volume of T2 lesions
    5 - Change in volume of T1 hypointense lesions
    6 - Number of new T1 hypointense lesions
    7 - Change in brain atrophy
    8 - Change in performance on symbol digit modalities test (SDMT) and Cognitive Battery Test
    9 - Overview of safety including adverse events (AEs) based on AE reporting, physical examinations, vital signs, clinical laboratories, suspected neuropathy, electrocardiography (ECG), suspected infection
    10 - Teriflunomide pharmacokinetics (PK) to allow the dose adjustment to the 14 mg adult equivalent dose for the rest of the
    study
    1 - Proporción de pacientes sin recidivas.
    2 - Número de lesiones en T2 nuevas o aumentadas
    3 - Número de lesiones en T1 realzadas con Gd
    4 - Cambio en el volumen de las lesiones en T2
    5 - Cambio en el volumen de las lesiones hipointensas en T1
    6 - Número de lesiones nuevas hipointensas en T1
    7 - Atrofia cerebral
    8 - Resultado de cognición medido a través de la Prueba de las Modalidades de Símbolos y Dígitos (Symbol Digit Modalities Test, SDMT) y una Prueba de la Batería Cognitiva cuando esté disponible.
    9 - Acontecimientos adversos (AA), exploraciones físicas, signos vitales, pruebas de laboratorio, neuropatías, ECG, sospecha de infección
    10 - FC de teriflunomida.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 9 : Over 96 weeks
    2, 3, 4, 5, 6 and 7 : At randomization, at 24, 48 and 96 weeks
    8 : At randomization, then every 24 weeks (SDMT only) and at 96 weeks
    10 : A total of 3 PK samples (blood samples) will be collected during the beginning of study, i.e., the 4-week PK run-in period (weeks 2, 3 and 4); patients entering the open label teriflunomide arm will re-do PK run-in (3 blood samples)
    1 y 9: Hasta 96 semanas
    2,3, 4, 5, 6 y 7: A la aleatorización, a la semana 24, 48 y 96 semanas
    8: A la aleatorización, y cada 24 semanas (SDMT sólo) y a las 96 semanas.
    10: Un total de 3 muestras de FC (muestras de sangre) serán recogidas durante el inicio del estudio.
    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 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 Yes
    E.8.1.7.1Other trial design description
    Option to go in an open label teriflunomide arm for patients having a relapse after PK run-in phase
    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 concerned3
    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
    Australia
    Canada
    China
    Israel
    Lebanon
    Russian Federation
    Turkey
    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 del último paciente
    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 months4
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days3
    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: 165
    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: 33
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 132
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    10-17 years of age for this study; patients will give assents and parents or legal guardian will give consents
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 165
    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
    Ninguno
    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 Decision2014-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
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