Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2009-015556-15
    Sponsor's Protocol Code Number:101MS325
    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:2010-03-24
    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 number2009-015556-15
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente
    A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis
    A.3.2Name or abbreviated title of the trial where available
    SURPASS
    A.4.1Sponsor's protocol code number101MS325
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiogen Idec 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 TYSABRI 300 mg concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderELAN PHARMA INTERNATIONAL LTD
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNATALIZUMAB
    D.3.9.3Other descriptive nameNATALIZUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo anti-integrina alfa-4 humanizado recombinante.
    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 COPAXONE 20 mg/ml solución inyectable en jeringa precargada
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA PHARMACEUTICALS LTD.
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLATIRAMERO ACETATO
    D.3.9.3Other descriptive nameGLATIRAMER ACETATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 REBIF 44 microgramos solución inyectable en jeringa precargada
    D.2.1.1.2Name of the Marketing Authorisation holderSERONO EUROPE LTD
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINTERFERON BETA1A
    D.3.9.3Other descriptive nameINTERFERON BETA1A
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number44
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeProducido en celulas de ovario de hamster chino (CHOK1) mediante tecnología de ADN recombinante.
    D.IMP: 4
    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 Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINTERFERON BETA1A
    D.3.9.3Other descriptive nameINTERFERON BETA1A
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number8.8 to 44
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeProducido en células ováricas de hamster chino (CHOK1) mediante tecnología de ADN recombinante.
    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
    Esclerosis Múltiple Recidivante-Remitente
    Relapsing-Remitting Multiple Sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este estudio es evaluar la eficacia (clínica y en la RMN) del cambio a natalizumab en comparación con el tratamiento con interferón Beta 1a o glatiramer acetato.
    E.2.2Secondary objectives of the trial
    El objetivo secundario del estudio es evaluar el efecto sobre la calidad de vida del cambio a natalizumab en comparación con el tratamiento con interferón Beta 1a o glatiramer acetato.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub estudio farmacogenómico para llevar a cabo análisis de biomarcadores.El análisis farmacogenómico explorará la identificación de polimorfismos genéticos específicos asociados con la respuesta al tratamiento del estudio.El ADN puede usarse para análisis de Polimorfismos de Nucleótido Único (SNP) de genes candidatos o de todo el genoma.
    E.3Principal inclusion criteria
    1.Haber firmado el consentimiento informado por escrito (en persona o por medio de un representante legal) para participar en el estudio y proporcionado autorización por escrito para el uso de información sanitaria protegida de acuerdo con las leyes locales.
    2.Tener un diagnóstico de esclerosis múltiple recidivante-remitente de acuerdo con los criterios revisados del Comité de McDonald (Polman 2005).
    3.Deben haber sido tratados con una pauta estable de glatiramer acetato (20 mg al día SC) o interferón Beta 1a (44 mcg 3 veces a la semana) como primera terapia principal para la EM durante 6 a 18 meses previos a la aleatorización. (Nota: el tratamiento previo con otra terapia para la EM con una duración total meenor o igual a 30 días no es motivo de exclusión [p.ej. se permite el ajuste de dosis a 44 mcg]).
    4.Haber presentado actividad de la enfermedad en los 12 meses previos a la selección mientras estaba en tratamiento; la actividad de la enfermedad se debe observar después de 6 meses en tratamiento como mínimo. La actividad de la enfermedad que cumple los requisitos se define como:
    Una o más recidivas clínicas O bien Dos o más lesiones nuevas en la RMN (lesiones Gd+ y/o hiperintensas en T2)
    A efectos de la inclusión: (a) una recidiva se define como signos y/o síntomas neurológicos documentados en la historia clínica por un neurólogo y de suficiente duración para que el Investigador o el médico que trata al paciente determinen que son compatibles con una recidiva de la EM o (b) la actividad en la RMN debe ser verificada por el centro de interpretación central.
    5.No haber recibido nunca natalizumab.
    6.Tener una edad comprendida entre 18 y 60 años, ambos incluidos, en el momento del consentimiento informado.
    7.Tener una puntuación documentada en la EDSS de 0,0 a 5,5, ambas incluidas.
    E.4Principal exclusion criteria
    1.Tener un diagnóstico de EM progresiva primaria, progresiva secundaria o recidivante progresiva (como definen Lublin and Reingold, 2001). Estos trastornos requieren la presencia de empeoramiento continuo de la enfermedad clínica durante un periodo de al menos 3 meses. Los pacientes con estos trastornos pueden presentar también recidivas superpuestas, pero se diferencian de los pacientes con EM recidivante-remitente por la ausencia de periodos clínicamente estables o de mejoría clínica.
    2.Tener intolerancia conocida, contraindicación o antecedentes de incumplimiento del uso de glatiramer acetato o interferón Beta 1a.
    3.Haber presentado una exacerbación (recidiva) de la EM en los 30 días previos a la aleatorización Y/O el paciente no se ha estabilizado tras una recidiva previa antes de la aleatorización, en opinión del Investigador.
    4.El Investigador considera que el paciente está inmunocomprometido basándose en la historia clínica, la exploración física, los análisis de laboratorio, o debido a tratamiento inmunosupresor o inmunomodulador previo.
    5.Pacientes en los que la RMN está contraindicada, o sea, que tienen marcapasos u otros dispositivos metálicos implantados contraindicados, han sufrido o tienen alto riesgo de efectos secundarios de gadolinio (Gd) o tienen claustrofobia que no puede manejarse médicamente.
    6.Antecedentes de enfermedades cardiacas, endocrinas, hematológicas, hepáticas, inmunológicas, metabólicas, urológicas, pulmonares, neurológicas, dermatológicas, psiquiátricas o renales clínicamente significativas (según lo determine el Investigador), u otras enfermedades importantes que impedirían la participación en un ensayo clínico.
    7.Antecedentes de neoplasias, incluyendo tumores sólidos y neoplasias hematológicas (con la excepción de carcinomas cutáneos basocelulares y espinocelulares extirpados completamente o considerados como curados).
    8.Antecedentes de virus de la inmunodeficiencia humana (VIH)
    9.Resultado positivo en la prueba del virus de la hepatitis C (prueba de anticuerpos frente al virus de la hepatitis C [HCV Ab]) o del virus de la hepatitis B (prueba del antígeno de superficie de la hepatitis [HBsAg] y/o de anticuerpos frente al núcleo de la hepatitis B [HBcAb]).
    10.Antecedentes de trasplante o de cualquier tratamiento anti-rechazo.
    11.Antecedentes de reacciones anafilácticas o alérgicas severas o hipersensibilidad conocida a fármacos.
    12.Enfermedad infecciosa clínicamente significativa (p.ej. celulitis, absceso, neumonía, septicemia) en los 30 días previos a la selección.
    13.Antecedentes de LMP.
    Historia del tratamiento
    14.Tratamiento previo con irradiación linfoide total, cladribina, mitoxantrona, fingolimod, vacunación con células T o con receptores de células T, ciclofosfamida, ciclosporina, azatioprina, metotrexato, micofenolato mofetilo o cualquier anticuerpo monoclonal terapéutico, incluyendo natalizumab o rituximab.
    15.Tratamiento previo con inmunoglobulina intravenosa (IgIV), plasmaféresis o citoféresis en los 6 meses previos a la aleatorización.
    16.Tratamiento con corticosteroides IV u orales o con 4-aminopiridina o productos relacionados en los 30 días previos a la aleatorización.
    Miscelánea
    17.Mujeres que se estén planteando quedarse embarazadas mientras estén en el estudio.
    18.Mujeres potencialmente fértiles que tengan una prueba de embarazo positiva en la Visita de Selección o en la Visita del Día 0 (Basal).
    19.Mujeres que se estén actualmente embarazadas o dando lactancia materna.
    20.Antecedentes de abuso de alcohol o de drogas en los 2 años previos a la inclusión.
    21.Falta de disposición o incapacidad para cumplir con los requisitos del protocolo incluyendo la presencia de cualquier trastorno (físico, mental o social) que pueda probablemente afectar a la capacidad del paciente para cumplir con el protocolo del estudio.
    22.Participación en cualquier estudio de un tratamiento en investigación o de una enfermedad en los 6 meses previos a la inclusión o de forma concurrente con este estudio.
    23.Pacientes con procedimientos electivos programados de antemano durante el periodo del estudio que en opinión del Investigador interferirían con los parámetros del ensayo.
    24.Pacientes con otros trastornos, hallazgos clínicos o motivos que en opinión del Investigador y/o del Promotor hagan que el paciente no sea adecuado para su inclusión en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal en este estudio es la tasa de recidivas anualizada en pacientes con esclerosis múltiple recidivante-remitente (EMRR).
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    Evaluador Ciego
    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.8.3 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA144
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 850
    F.4.2.2In the whole clinical trial 1800
    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 Decision2010-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 18 14:20:43 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA