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    Summary
    EudraCT Number:2010-024000-10
    Sponsor's Protocol Code Number:101MS206
    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:2011-05-26
    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 number2010-024000-10
    A.3Full title of the trial
    A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis
    Estudio aleatorizado, ciego, con grupo paralelo en fase 2 en el que se explora la seguridad, tolerabilidad y eficacia de pautas posológicas múltiples de Natalizumab en sujetos adultos con esclerósis múltiple recidivante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis
    Estudio para evaluar para la seguridad y la eficacia en el efecto de diferentes dosis de TYSABRI en la esclerosis múltiple recidivante
    A.3.2Name or abbreviated title of the trial where available
    REFINE
    A.4.1Sponsor's protocol code number101MS206
    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 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 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 Limited
    B.5.2Functional name of contact pointNot available
    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.5.6E-mailneurologyclinicaltrial@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 TYSABRI
    D.2.1.1.2Name of the Marketing Authorisation holderElan Pharma International 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.3.1Product nameNatalizumab for IV Infusion
    D.3.2Product code AN100226; BG00002
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 189261-10-7
    D.3.9.2Current sponsor codeAN100226; BG00002
    D.3.9.4EV Substance CodeSUB22282
    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) 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 Yes
    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 nameNatalizumab for Subcutaneous Injection
    D.3.2Product code AN100226; BG00002
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNNATALIZUMAB
    D.3.9.1CAS number 189261-10-7
    D.3.9.2Current sponsor codeAN100226; BG00002
    D.3.9.4EV Substance CodeSUB22282
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    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
    Esclerósis múltiple recidivante
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis characterized by unpredictable relapses followed by
    periods with no new signs of disease activity
    La esclerosis múltiple se caracteriza por recaídas imprevisibles, seguido de períodos sin nuevos signos de actividad de la enfermedad
    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 13.1
    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
    To explore the effects of multiple regimens of natalizumab on disease
    activity and safety in subjects with relapsing remitting MS.
    El objetivo principal de este estudio es explorar los efectos de múltiples pautas posológicas de natalizumab sobre la actividad de la enfermedad y la seguridad en sujetos con EM remitente recurrente
    E.2.2Secondary objectives of the trial
    • To characterize and compare PK/PD profiles across multiple dose
    regimens of natalizumab.
    • To characterize effects on secondary brain MRI measures.
    • To evaluate potential laboratory markers of immune function and
    trafficking across the treatment regimens.
    • To assess the safety and tolerability across multiple dose regimens
    Caracterizar y comparar los perfiles FC/FD en múltiples pautas posológicas de natalizumab.
    Caracterizar los efectos sobre las medidas secundarias de la RMN cerebral. Evaluar los posibles
    marcadores de laboratorio de la actividad y el tráfico inmunitarios en las diferentes pautas posológicas.
    Evaluar la seguridad y la tolerabilidad en múltiples pautas posológicas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand the purpose and risks of the study and provide
    signed and dated informed consent and authorization to use protected
    health information (PHI) in accordance with national and local subject
    privacy regulations.
    2. Aged 18 to 55 years old, inclusive, at the time of informed consent.
    3. Subjects of childbearing potential must practice effective
    contraception during the study.
    4. A documented diagnosis of RRMS.
    5. Free of MS relapse, as determined by the enrolling Investigator, for 12
    months prior to randomization.
    6. Treatment with natalizumab according to locally approved pescribing
    information for a minimum of the 12 months immediately prior to
    randomization. The subject must have received at least 11 doses of
    natalizumab in the 12 months prior to randomization with no missed doses in the 3 months prior to randomization.
    7. In the 12 months prior to the initiation of natalizumab, subject must
    have experienced a minimal level of disease activity as defined by:
    • 2 or more documented clinical relapses
    OR
    • 1 relapse and documented MRI activity, defined by the presence of at
    least one Gd enhancing lesion on MRI, unrelated to the relapse
    1. Capacidad de comprender el objetivo y los riesgos del estudio y de dar el consentimiento informado firmado y fechado y la autorización para usar información de salud protegida (Protected Health Information, PHI) de acuerdo con la normativa nacional y local sobre la privacidad de los sujetos. 2. Edad de entre 18 y 55 años, ambos inclusive, en el momento del consentimiento informado. 3. Los
    sujetos en edad fértil deben tomar medidas anticonceptivas eficaces durante el estudio 4. Diagnóstico documentado de EMRR. 5. Ausencia de recaída de la EM, determinada por el investigador que realiza
    la inscripción, en los 12 meses previos a la aleatorización. 6. Tratamiento con natalizumab de acuerdo con la información de la ficha técnica aprobada localmente al menos durante los 12 meses
    inmediatamente anteriores a la aleatorización. El sujeto debe haber recibido un mínimo de 11 dosis de natalizumab en los 12 meses previos a la aleatorización y no haberse saltado ninguna en los 3 meses previos a la aleatorización. 7. En los 12 meses previos al inicio del natalizumab, el sujeto debe haber experimentado un grado mínimo de actividad de la enfermedad, definido por: 2 o más recaídas clínicas documentadas O 1 recaída y actividad documentada en la RMN, definida como la presencia de al menos una lesión potenciada con Gd en la RMN no relacionada con la recaída
    E.4Principal exclusion criteria
    1. Known history of Human Immunodeficiency Virus (HIV).
    2. Known history of hepatitis C (test for hepatitis C virus antibody [HCV
    Ab]) or hepatitis B virus (test for Hepatitis B Surface Antigen [HBsAg]
    and/or Hepatitis B Core Antibody [HBcAb]).
    3. Positive for anti-natalizumab antibodies at Screening.
    4. MRI positive for Gd-enhancing lesions at study entry.
    5. Subjects for whom MRI is contraindicated, e.g., have a pacemaker or
    other contraindicated implanted metal devices, have suffered, or are at
    risk for, side effects from Gd, or have claustrophobia that cannot be
    medically managed.
    6. History of any clinically significant (as determined by the
    Investigator) cardiac, endocrinologic, hematologic, hepatic,
    immunologic, metabolic (including diabetes), urologic, pulmonary,
    neurologic (except for RRMS), dermatologic, psychiatric, renal, or
    other major disease that would preclude participation in a clinical study.
    7. History of malignant disease, including solid tumors and hematologic
    malignancies (with the exception of basal cell and squamous cell
    carcinomas of the skin that have been completely excised and are
    considered cured).
    8. History of transplantation or any anti-rejection therapy.
    9. History of severe allergic or anaphylactic reactions or known
    hypersensitivity to any drug.
    10. A clinically significant infectious illness (e.g., cellulitis, abscess,
    pneumonia, septicemia) within 30 days prior to Screening, or PML or
    other opportunistic infections at any time.
    11. Signs or symptoms suggestive of any serious infection, based on
    medical history, physical examination, or laboratory testing, as
    determined by the Investigator.
    MS Treatment History
    12. Prior treatment with total lymphoid irradiation.
    13. Prior treatment with cladribine, mitoxantrone, fingolimod, T-cell or
    T-cell receptor vaccination, cyclophosphamide, cyclosporine,
    azathioprine, methotrexate, mycophenolate mofetil, or any therapeutic
    monoclonal antibody other than natalizumab within 24 months
    prior to randomization.
    14. Prior treatment with intravenous immunoglobulin (IVIg),
    plasmapheresis, or cytapheresis within 12 months prior to
    randomization.
    15. Treatment with IV or oral corticosteroids (topical corticosteroids are
    acceptable) or related products within 3 months prior to randomization.
    Miscellaneous
    16. Female subjects considering becoming pregnant while in the study.
    17. Female subjects who are pregnant or currently breastfeeding.
    18. History of drug or alcohol abuse within 2 years prior to entry per
    Investigator judgment.
    19. Unwillingness or inability to comply with the requirements of this
    protocol including the presence of any condition (physical, mental, or
    social) that is likely to affect the subject's ability to comply with the study protocol.
    20. Receiving any other investigational treatment within the 12 months
    prior to Screening or concurrent with this study.
    21. Any pre-scheduled elective procedure during the study period that,
    in the opinion of the Investigator, would interfere with study endpoints.
    22. Any other condition, clinical finding, or reason that, in the opinion of
    the Investigator and/or the Sponsor, makes the subject unsuitable for
    enrollment into this study.
    23. Previous participation in this study at randomization
    1. Antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH). 2. Antecedentes conocidos de infección por el virus de la hepatitis C [prueba de detección de anticuerpos para el virus de la hepatitis C (Ac VHC)] o el virus de la hepatitis B [prueba de detección del antígeno de superficie del virus de la hepatitis B (HBsAg) y/o anticuerpos del antígeno nuclear del virus de la hepatitis B (HBcAb)]. 3. Anticuerpos anti-natalizumab positivos en la selección. 4. RMN positiva para lesiones potenciadas con Gd en la inscripción en el estudio. 5. Sujetos en los que la RMN está contraindicada, por ejemplo, que tienen un marcapasos u otros dispositivos metálicos implantados contraindicados, presentan riesgo de experimentar efectos secundarios del Gd o sufren claustrofobia que
    no puede tratarse médicamente. 6. Antecedentes de cualquier enfermedad clínicamente significativa (según determine el investigador) cardíaca, endocrinológica, hematológica, hepática, inmunitaria, metabólica (incluyendo la diabetes), urológica, pulmonar, neurológica (excepto la EMRR), dermatológica, psiquiátrica, renal u otra enfermedad importante que impida participar en un estudio
    clínico. 7. Antecedentes de cáncer, incluyendo tumores sólidos y cánceres hematológicos (con la excepción de los carcinomas basocelulares y de células escamosas de la piel que se han extirpado por completo y se consideran curados). 8. Antecedentes de trasplante o tratamiento antirrechazo. 9. Antecedentes de reacciones alérgicas o anafilácticas graves o hipersensibilidad conocida a cualquier
    fármaco. 10. Enfermedad infecciosa clínicamente significativa (por ejemplo, celulitis, absceso, neumonía, septicemia) en los 30 días previos a la selección o LMP u otras infecciones oportunistas en
    cualquier momento. 11. Signos o síntomas indicativos de cualquier infección grave, en base al historial médico, la exploración física o las pruebas de laboratorio, según determine el investigador. Tratamiento
    previo de la EM 12. Tratamiento previo con irradiación linfoide total. 13. Tratamiento previo con cladribina, mitoxantrona, fingolimod, vacuna con células T o receptores de células T, ciclofosfamida,
    ciclosporina, azatioprina, metotrexato, micofenolato mofetil o cualquier anticuerpo monoclonal terapéutico distinto del natalizumab en los 24 meses previos a la aleatorización 14. Tratamiento previo
    con inmunoglobulina intravenosa (Ig i.v.), plasmaféresis o citaféresis en los 12 meses previos a la aleatorización. 15. Tratamiento con corticoesteroides i.v. u orales (los corticoesteroides tópicos son
    aceptables) o productos relacionados en los tres meses previos a la aleatorización. Varios 16. Sujetos del sexo femenino que se estén planteando quedarse embarazadas durante el estudio. 17. Sujetos del sexo femenino que estén embarazadas o amamantando. 18. Antecedentes de abuso de drogas o alcohol en los dos años previos a la inscripción en el estudio, a criterio del investigador. 19. Falta de voluntad o incapacidad de cumplir con los requisitos de este protocolo, incluyendo la presencia de cualquier enfermedad (física, mental o social) que probablemente afecte la capacidad del sujeto de cumplir con el protocolo del estudio. 20. Recepción de cualquier otro tratamiento en investigación en los 12 meses previos a la selección o de manera simultánea a este estudio. 21. Cualquier intervención quirúrgica programada previamente durante el estudio que, en opinión del investigador, interferiría en los criterios de valoración del estudio. 22. Cualquier otra enfermedad, hallazgo clínico o motivo que, en opinión del investigador y/o el patrocinador, hace que el sujeto no sea apto para su inscripción en este estudio. 23. Participación previa en este estudio en la aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative number of combined unique active lesions (sum of the
    number of new Gd enhancing and new or newly enlarging T2
    hyperintense lesions not associated with Gd enhancement on T1
    weighted scans) based on brain MRI scans
    Número acumulado de lesiones activas únicas nuevas (suma de lesiones Gd+ nuevas y de lesiones hiperintensas en T2 nuevas o de nuevo crecimiento no asociadas a imágenes en T1 potenciadas con Gd) según las RMN cerebrales
    E.5.1.1Timepoint(s) of evaluation of this end point
    At weeks 12, 24, 36, 48 and 60.
    En las semanas 12, 24, 36, 48 y 60.
    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 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    The end of study is last subject, last visit for final collection of data
    El fin del estudio es la última visita del último sujeto para la obtención de datos final
    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 months3
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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 Decision2011-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-18
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