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    Summary
    EudraCT Number:2009-017490-38
    Sponsor's Protocol Code Number:101MS205
    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:2010-02-19
    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 number2009-017490-38
    A.3Full title of the trial
    "Estudio aleatorizado de interrrupción de tratamiento con Natalizumab"

    "Randomized Treatment Interruption of Natalizumab"
    A.3.2Name or abbreviated title of the trial where available
    RESTORE
    A.4.1Sponsor's protocol code number101MS205
    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 Ltd
    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 recombinante humanizado anti-integrina alfa-4.
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name AVONEX 30 microgramos/0,5 ml (Interferón Beta - 1a) Solución inyectable
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINTERFERON BETA1A
    D.3.9.3Other descriptive nameINTERFERON BETA1A
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 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 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: 4
    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 URBASON FORTE
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS Deutschland GmbH
    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 Powder and solvent 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 INNMETHYLPREDNISOLONE
    D.3.9.1CAS number 83-43-2
    D.3.9.3Other descriptive nameURBASON FORTE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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.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 injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    El natalizumab es un medicamento muy eficaz utilizado en el tratamiento de pacientes con esclerosis múltiple (EM) recidivante.

    Se trata de un estudio prospectivo y aleatorizado, en pacientes con formas recidivantes de la EM que han recibido tratamiento con natalizumab durante un mínimo de 12 meses, sin recaídas durante ese tiempo.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11
    E.1.2Level LLT
    E.1.2Classification code 10063399
    E.1.2Term Esclerosis múltiple remitente-recurrente
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1.Cómo evoluciona la recuperación de la función inmunitaria, utilizando los marcadores indirectos
    2. Cómo evoluciona la reaparición de pruebas radiológicas y/o clínicas de actividad de la EM
    3. El efecto de los tratamientos inmunomodulares alternativos sobre la recuperación de la función inmunitaria y la actividad de la EM.
    4. Las relaciones entre la concentración de natalizumab, la saturación de la integrina alfa-4 y los indicadores inmunitarios y clínicos en los pacientes individuales y en los grupos de tratamiento.
    E.2.2Secondary objectives of the trial
    1. Cómo evoluciona la reaparición de los efectos del natalizumab, medidos por la función inmunitaria y los indicadores radiológicos y/o clínicos de actividad de la enfermedad tras reintroducir el tratamiento con natalizumab.
    2. La relación entre la concentración de natalizumab, la saturación de la integrina alfa-4 y otros marcadores farmacodinámicos tras la reintroducción del tratamiento con natalizumab.
    3. Los análisis genéticos relevantes para el tratamiento con natalizumab y la biología del VJC.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Cuatro sub-estudios están incluidos en 101MS205 version 1 fechado 14 December 2009.
    1. Función leucocitaria (adhesión y/o transmigración celular) de sangre entera.
    2. Determinar la secreción de trifosfato de adenosina (ATP) por los linfocitos CD4 de sangre entera.
    3. Presencia de celulas mononucleares, calculo del índice de inmunoglobulina y bandas oligoclonales [BOC] en el LCR.
    4. Análisis genéticos relevantes para el tratamiento con natalizumab y la biología del VJC de ADN de sangre
    E.3Principal inclusion criteria
    1. Capacidad de comprender la finalidad y los riesgos de este estudio y firmar un consentimiento informado y fechado y la autorización para utilizar la información sanitaria protegida (PHI) según lo establecido en la legislación nacional y local sobre confidencialidad.
    2. Tener entre 18 y 60 años de edad, ambas incluidas, en el momento del consentimiento informado.
    3. Las pacientes en edad fértil deben utilizar un método anticonceptivo eficaz durante el estudio.
    4. Diagnóstico de EM recidivante de acuerdo con la ficha técnica local aprobada.
    5. Tratamiento con natalizumab de acuerdo con la ficha técnica local aprobada durante al menos los 12 meses anteriores a la asignación aleatoria. El paciente deberá haber recibido al menos 11 dosis de natalizumab en los 12 meses anteriores a la asignación aleatoria y no haberse perdido ninguna dosis en los 3 meses anteriores a la misma.
    6. No haber sufrido recidivas en los 12 meses anteriores a la asignación aleatoria.
    7. No debe presentar, a juicio del investigador, signos y síntomas indicadores de infección grave, basándose en el historial médico, el examen físico o las pruebas de laboratorio.
    E.4Principal exclusion criteria
    1. Antecedentes de infección por el virus de la inmunodeficiencia humana (VIH).
    2. Antecedentes de hepatitis C (prueba de anticuerpos contra el virus de la hepatitis C [HCV Ab]) o hepatitis B (prueba del antígeno de superficie de la hepatitis B [HBsAg] y/o anticuerpo de nucleocápside de la hepatitis B [HBcAb]).
    3. Presencia de anticuerpos anti-natalizumab en el momento de la selección.
    4. Indicios de lesiones Gd+ en el momento de la selección.
    5. Pacientes en los que está contraindicada la RM por llevar marcapasos u otros aparatos médicos implantados, y pacientes que han sufrido o presentan riesgo de sufrir los efectos secundarios del Gd, o que sufren claustrofobia que no se puede tratar médicamente.
    6. Antecedentes de alguna enfermedad clínicamente significativa (según criterio del investigador) cardíaca, endocrina, hematológica, hepática, inmunitaria, metabólica (incluyendo diabetes), urológica, pulmonar, neurológica, dermatológica, psiquiátrica o renal, u otra enfermedad grave, que excluirían la participación en un ensayo clínico.
    7. Antecedentes de neoplasia maligna, incluyendo tumores y neoplasias malignas hematológicas (a excepción de carcinomas cutáneos de células basales y epidermoide que hayan sido extirpados completamente y se consideren curados).
    8. Antecedentes de trasplantes o algún tratamiento contra el rechazo.
    9. Antecedentes de reacciones alérgicas o anafilácticas intensas o hipersensibilidad conocida a algún fármaco.
    10. Enfermedad infecciosa clínicamente significativa (p. ej., celulitis, abscesos, neumonía o septicemia) en los 30 días anteriores a la selección, o LMP u otra infección oportunista en cualquier momento
    11. Tratamiento previo con irradiación linfocítica total.
    12. Tratamiento previo con cladribina, mitoxantrona, fingolimod, vacunación con linfocitos T o receptores de linfocitos T, ciclofosfamida, ciclosporina, azatioprina, metotrexato, micofenolato de mofetilo o cualquier anticuerpo monoclonal terapéutico distinto de natalizumab en los 24 meses anteriores a la asignación aleatoria.
    13. Tratamiento previo con inmunoglobulina intravenosa (IgIV), plasmaféresis o citaféresis en los 12 meses anteriores a la asignación aleatoria.
    14. Tratamiento con corticosteroides IV o por vía oral (se acepta el tratamiento con corticosteroides inhalados) o productos relacionados en los 3 meses anteriores a la asignación aleatoria.
    15. Mujeres que estén considerando quedarse embarazadas durante el estudio.
    16. Mujeres que estén embarazadas o en período de lactancia.
    17. Antecedentes de abuso de drogas o alcohol en los 2 años anteriores al ingreso en el estudio.
    18. Incapacidad o falta de voluntad para cumplir con los requisitos de este protocolo, incluida la presencia de alguna enfermedad (física, mental o social) que pueda afectar a la capacidad del paciente para cumplir con el protocolo.
    19. Administración de otro tratamiento en fase de investigación en los 12 meses anteriores a la selección o de forma simultánea a este estudio.
    20. Cualquier procedimiento previamente programado y realizado durante el período de estudio que, a juicio del investigador, pudiera interferir en los criterios de eficacia del estudio.
    21. Cualquier otro trastorno, hallazgo clínico o motivo por los que, en opinión del investigador y/o el promotor, no sea adecuado reclutar al paciente para este estudio.
    22. Participación previa en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Concentration de Natalizumab , funcion inmune, farmacodinámica, actividad de la enfermedad
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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) 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 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
    Rater Blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 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
    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 months9
    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 months9
    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 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 125
    F.4.2.2In the whole clinical trial 200
    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 Decision2010-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-02
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