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    Summary
    EudraCT Number:2013-001025-53
    Sponsor's Protocol Code Number:109MS405
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-03-03
    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 number2013-001025-53
    A.3Full title of the trial
    A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsule (TECNERGY)
    Estudio abierto multicéntrico para evaluar el cansancio en sujetos con esclerosis múltiple recidivante-remitente durante el tratamiento con Tecfidera® (dimetil fumarato) en cápsulas duras gastrorresistentes (TECNERGY)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study that evaluates Fatigue in Multiple Sclerosis Patients taking Tecfidera® (Dimethyl Fumarate)
    Un estudio que evalúa la fatiga en pacientes con esclerosis múltiple que están tomandoTecfidera® (dimetil fumarato)
    A.3.2Name or abbreviated title of the trial where available
    TECNERGY
    A.4.1Sponsor's protocol code number109MS405
    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 SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointPedro Allende Echevarrieta
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+3491702 79 63
    B.5.6E-mailpedro.allendeechevarrieta@biogenidec.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 Tecfidera (BG00012)
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTecfidera
    D.3.2Product code BG00012
    D.3.4Pharmaceutical form Gastro-resistant 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 INNDIMETHYL FUMARATE
    D.3.9.1CAS number 624-49-7
    D.3.9.2Current sponsor codeBG00012
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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 Yes
    D.2.1.1.1Trade name Tecfidera (BG00012)
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTecfidera
    D.3.2Product code BG00012
    D.3.4Pharmaceutical form Gastro-resistant 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 INNDIMETHYL FUMARATE
    D.3.9.1CAS number 624-49-7
    D.3.9.2Current sponsor codeBG00012
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing-Remitting Multiple Sclerosis
    Esclerosis múltiple recidivante-remitente
    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 17.1
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting 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
    The primary objective of this study is to determine whether DMF taken over 12 months is effective in reducing MS related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in subjects with RRMS.
    El objetivo principal del estudio es determinar si el tratamiento con DMF durante 12 meses disminuye eficazmente el cansancio asociado a la EM, determinado mediante la variación media en la Escala de cansancio para las funciones motoras y cognitivas (FSMC), en pacientes con EMRR.
    E.2.2Secondary objectives of the trial
    To investigate changes from Baseline in FSMC and fatigue severity (Fatigue Severity Scale [FSS]) at 1, 3, 6, 9, and 12 months in subjects receiving DMF

    To assess the impact of DMF on patient reported outcomes (PROs), including work productivity (Work Productivity and Activity Impairment-Multiple Sclerosis questionnaire [WPAI-MS]), health-related quality of life (Short Form Health Survey [SF-12] or the 15-dimensional health-related quality of life [15D HRQoL] questionnaire), depression (Beck Depression Inventory-Fast Screen [BDI-FS]), and sleepiness (Epworth Sleepiness Scale [ESS]) at 6 and 12 months in subjects receiving DMF

    To examine whether an association exists between fatigue and baseline demographics (e.g., age and sex) and disease characteristics (e.g., disease duration, baseline disease activity, treatment history, expanded disability status scale [EDSS] score, and PROs)

    To assess any changes in fatigue-related medication use
    Investigar la variación de la FSMC y de la intensidad del cansancio (Escala FSS) entre el momento basal y los meses 1, 3, 6, 9 y 12 de tratamiento con DMF.
    Evaluar el efecto del tratamiento con DMF sobre los resultados comunicados por los pacientes (RCP) acerca de la productividad laboral (Cuestionario WPAI-MS), la calidad de vida relacionada con la salud (Cuestionario SF-12 o Cuestionario 15D HRQoL), la depresión (Escala de depresión de Beck - evaluación rápida [BDI-FS]) y la somnolencia (Escala de somnolencia de Epworth [ESS]) a los 6 y 12 meses de tratamiento con DMF.
    Analizar si existe relación entre el cansancio, los datos demográficos (por ejemplo, sexo, edad) y las características clínicas basales (por ejemplo, duración de la enfermedad, actividad de la enfermedad en el momento basal, tratamientos previos, puntuación en la Escala ampliada del estado de discapacidad [EDSS] y RCP).
    Evaluar todos los cambios efectuados en la medicación para el cansancio.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biomarker Sub-Study. Subjects who consent to participate will provide blood samples that will be used to identify or verify deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and serum markers associated with disease and response to DMF.
    Subestudio de análisis de biomarcadores. Los sujetos que acceden a participar proporcionarán muestras de sangre que se utilizarán para identificar o verificar en las muestras la presencia de ácido desoxirribonucleico (ADN), ácido ribonucleico (ARN), y los marcadores séricos de la enfermedad y su respuesta al DMF.
    E.3Principal inclusion criteria
    Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.

    Have a confirmed diagnosis of RRMS and satisfy the therapeutic indication as described in the local label.

    Have a stable EDSS (as assessed by the Investigator) and have been on the same (type and dosage) standard of care first line treatment for at least 6 months.

    If taking antidepressants, amphetamine, modafinil, or fampridine (Fampyra), subject must be assessed as having been clinically stable for at least 3 months prior to the Baseline Visit.

    Age >= 18 years at the time of informed consent.

    FSMC total score >= 43 (mild fatigue) at Baseline.

    As perceived by the Investigator, have the ability to comply with all requirements of the study protocol.

    Female subjects of childbearing potential who are not surgically sterile must practice effective contraception during their participation in the study and be willing and able to continue contraception for 12 weeks after their last dose of study treatment.
    Tener la capacidad de comprender el objetivo y los riesgos del estudio y de dar el consentimiento informado por escrito, firmando y fechando el documento correspondiente, así como de autorizar la utilización de información sanitaria confidencial conforme a la legislación nacional y local de confidencialidad de los datos del paciente.

    Tener un diagnóstico confirmado de EMRR y cumplir la indicación terapéutica que se indica en la ficha técnica local.

    Presentar una EMRR estable (conforme a lo determinado por el investigador) y haber recibido el mismo tratamiento de primera línea de referencia (tipo y dosis) durante los últimos seis meses.

    En caso de recibir tratamiento con antidepresivos, anfetamina, modafinilo o fampridina (Fampyra), el paciente deberá haber permanecido clínicamente estable desde al menos tres meses antes de la visita basal.

    Edad >= 18 años en el momento del consentimiento informado.

    Puntuación total en la FSMC >= 43 (cansancio leve) en el momento basal.

    Ser capaz, en opinión del investigador, de cumplir todos los requisitos del protocolo del estudio.

    Las pacientes en edad fértil que no se hayan sometido a esterilización quirúrgica deberán utilizar métodos anticonceptivos eficaces durante su participación en el estudio y estar dispuestas a mantenerlos, y ser capaces de hacerlo, hasta 12 semanas después de la última dosis de tratamiento del estudio.
    E.4Principal exclusion criteria
    Diagnosis of major depression, as identified by the Investigator.

    Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS.

    History of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical trial.

    History of a relapse within 90 days prior to study enrollment or showing transient symptoms derived from a previous relapse, irrespective of time of symptom onset.

    Treatment of MS relapse within 90 days prior to study enrollment.

    History of a positive test result for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody.

    Female subjects who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding.

    Impaired hepatic or renal function, as perceived by the Investigator.

    Any prior treatment with DMF (or other fumarate derivative), total lymphoid irradiation, cladribine, fingolimod, T cell or T-cell receptor vaccination, or any therapeutic monoclonal antibody.

    Treatment within 1 year prior to study enrollment with mitoxantrone or cyclophosphamide.

    Treatment within 6 months prior to study enrollment with cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, intravenous immunoglobulin, plasmapheresis, cytapheresis, or another investigational drug or approved therapy for investigational use.

    Current enrollment in any other clinical studies.

    Known to suffer from narcolepsy or another significant sleep disorder.

    Comorbidity that may have an impact on fatigue.

    Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
    Diagnóstico de depresión mayor identificado por el investigador.

    Diagnóstico de EM progresiva primaria, progresiva secundaria o progresiva recidivante.

    Antecedentes de neoplasia maligna (excepto el carcinoma basocelular extirpado por completo antes de la inclusión en el estudio), reacciones alérgicas graves o anafilácticas o hipersensibilidad a fármacos, anomalías analíticas indicativas de una enfermedad importante o enfermedad importante que impida la participación en un ensayo clínico.

    Antecedentes de recidiva en los 90 días precedentes a la inclusión en el estudio o presencia de síntomas transitorios debidos a una recidiva previa, con independencia del momento en que apareció el síntoma.

    Haber recibido tratamiento para una recidiva de la EM en los 90 días precedentes a la inclusión en el estudio.

    Antecedentes de resultado positivo en la prueba del virus de la inmunodeficiencia humana, del anticuerpo del virus de la hepatitis C o del virus de la hepatitis B (definida como positividad para el antígeno de superficie o para el anticuerpo nuclear del virus de la hepatitis B).

    Mujeres embarazadas o que tengan previsto quedarse embarazadas durante el estudio, o que estén en período de lactancia.

    Trastorno de la función hepática o renal, a criterio del investigador.

    Antecedentes de tratamiento con DMF (u otro derivado del fumarato), irradiación linfática total, cladribina, fingolimod, vacunas de linfocitos T o de receptores de linfocitos T o cualquier anticuerpo monoclonal terapéutico.

    Tratamiento con mitoxantrona o ciclofosfamida durante el último año antes de la inclusión en el estudio.

    Tratamiento con ciclosporina, azatioprina, metotrexato, micofenotalo mofetilo, inmunoglobulinas intravenosas, plasmaféresis, citaféresis, otro fármaco experimental u otro tratamiento aprobado para uso experimental en los seis meses previos a la inclusión en el estudio.

    Participación actual en otros estudios clínicos.

    Narcolepsia o cualquier otro trastorno importante del sueño.

    Enfermedades concomitantes que afecten al cansancio.

    Otro motivo no especificado que, en opinión del investigador o de Biogen Idec, impida la inclusión del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from Baseline in MS-related fatigue (FSMC) at 12 months in subjects receiving DMF.
    Variación media del cansancio asociado a la EM (FSMC) entre el momento basal y el mes 12 de tratamiento con DMF.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    Mean change from Baseline in fatigue (FSMC and FSS) at 1, 3, 6, 9, and 12 months in subjects receiving DMF

    Mean change from Baseline in work productivity, quality of life, depression, and sleepiness at 6 and 12 months in subjects receiving DMF

    Change in MS-related fatigue (FSMC) status (improved [> 4.5 increase], stable [within ±4.5], and worsened [> 4.5 decrease])

    Correlation of fatigue with baseline demographics and disease characteristics

    Proportion of subjects with reduced dose or discontinuation of fatigue related medications at 6 and 12 months
    Variación media del cansancio (FSMC y FSS) entre el momento basal y los meses 1, 3, 6, 9 y 12 de tratamiento con DMF.

    Variación media de la productividad laboral, la calidad de vida, la depresión y la somnolencia entre el momento basal y los meses 6 y 12 de tratamiento con DMF.

    Variación del estado de cansancio asociado a la EM (FSMC) (mejoría [aumento > 4,5], estabilización [variación de ± 4,5] o empeoramiento [disminución > 4,5]).

    Correlación entre el cansancio y las características demográficas y clínicas basales.

    Porcentaje de pacientes a los que se ha reducido o retirado la medicación para el cansancio a los 6 y 12 meses.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Mean change from Baseline in fatigue (FSMC and FSS) at 1, 3, 6, 9, and 12 months in subjects receiving DMF

    Mean change from Baseline in work productivity, quality of life, depression, and sleepiness at 6 and 12 months in subjects receiving DMF

    Change in MS-related fatigue (FSMC) status (improved [> 4.5 increase], stable [within ±4.5], and worsened [> 4.5 decrease])

    Correlation of fatigue with baseline demographics and disease characteristics

    Proportion of subjects with reduced dose or discontinuation of fatigue related medications at 6 and 12 months
    Variación media del cansancio (FSMC y FSS) entre el momento basal y los meses 1, 3, 6, 9 y 12 de tratamiento con DMF.

    Variación media de la productividad laboral, la calidad de vida, la depresión y la somnolencia entre el momento basal y los meses 6 y 12 de tratamiento con DMF.

    Variación del estado de cansancio asociado a la EM (FSMC) (mejoría [aumento > 4,5], estabilización [variación de ± 4,5] o empeoramiento [disminución > 4,5]).

    Correlación entre el cansancio y las características demográficas y clínicas basales.

    Porcentaje de pacientes a los que se ha reducido o retirado la medicación para el cansancio a los 6 y 12 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 No
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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: The end of study is last subject, last visit for final collection of data for the primary outcome.
    La última visita del último paciente: El fin del estudio es el úlltimo paciente, la última visita de la última recogida de datos para el resultado primario.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 320
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 320
    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)
    There are no post trial treatment plans. DMF will not be made available to subjects after the end of the study under this protocol.
    No hay planes de tratamiento después del ensayo. DMF no se pondrá a disposición de los sujetos después del final del estudio.
    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 Decision2015-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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