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    Summary
    EudraCT Number:2008-006786-92
    Sponsor's Protocol Code Number:AC-058B201
    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:2009-05-06
    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 number2008-006786-92
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, de búsqueda de dosis para evaluar la eficacia, seguridad y tolerabilidad de tres dosis de ACT-128800, un agonista oral de los receptores S1P1, durante 24 semanas en pacientes con esclerosis múltiple recurrente-remitente
    A.4.1Sponsor's protocol code numberAC-058B201
    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 SponsorActelion Pharmaceuticals Ltd
    B.1.3.4CountrySwitzerland
    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 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 nameACT-128800
    D.3.2Product code ACT-128800
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeACT-128800
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 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 nameACT-128800
    D.3.2Product code ACT-128800
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeACT-128800
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 nameACT-128800
    D.3.2Product code ACT-128800
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeACT-128800
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Esclerosis Múltiple Recurrente-Remitente
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    1.Demostrar la eficacia de al menos una de las tres dosis de ACT-128800 en comparación con placebo, en pacientes con esclerosis múltiple recurrente-remitente (RRMS) en el número acumulado de nuevas lesiones intensificadas con gadolinio por paciente, registradas mediante escáner de resonancia magnética ponderado en T1 en las semanas 12, 16, 20, y 24 posteriores al inicio del tratamiento del estudio.
    E.2.2Secondary objectives of the trial
    1.Evaluar los efectos de ACT-128800 en la tasa anual de recaídas confirmadas en las 24 semanas del inicio del tratamiento con el fármaco del estudio.
    2.Evaluar los efectos de ACT-128800 sobre el tiempo hasta la primera recaída confirmada, en las 24 semanas del inicio del tratamiento con el fármaco del estudio.
    3.Evaluar la seguridad y tolerabilidad de ACT-128800.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Hombres y mujeres con edades comprendidas entre los 18 y los 55 años (inclusive).
    2.Las mujeres con potencial reproductivo deberán:
    • Disponer de una prueba de embarazo realizada en suero negativa, en la selección y una prueba de embarazo en orina negativa en la visita basal.
    • Estar de acuerdo en utilizar dos métodos anticonceptivos desde la visita de selección hasta las 8 semanas posteriores a la interrupción del tratamiento del estudio.
    De los dos métodos anticonceptivos, uno debe ser del Grupo 1, y otro del Grupo 2, definidos como:
    &#61485; Grupo 1: Anticonceptivo hormonal oral, implantable, transdérmico o inyectable, dispositivo intrauterino, esterilización femenina (ligadura de trompas), o esterilización de la pareja (vasectomía). Si se elige un anticonceptivo hormonal de este grupo, debe haber iniciado su uso al menos 1 mes antes de la aleatorización.
    &#61485; Grupo 2: Preservativo, diafragma o anillo cervical, todos en combinación con un espermicida.
    Los métodos de abstención y del ritmo no se consideran métodos anticonceptivos aceptables.
    3.Presentación del diagnóstico de RRMS como se define en los criterios diagnósticos revisados de McDonald (2005) para la esclerosis múltiple (MS).
    4.Pacientes ambulatorios y con una puntuación en la escala del estado de incapacidad ampliada (Expanded Disability Status Scale, EDSS) entre 0 y 5.5 (inclusive).
    5.Con al menos una de las siguientes características de la RRMS:
    • Una o más recaídas documentadas en los 12 meses previos a la visita de selección,
    • Dos o más recaídas documentadas en los 24 meses previos a la visita de selección,
    • Al menos una lesión intensificada con gadolinio, detectada mediante MRI ponderada en T1 en la visita de selección (lectura centralizada).
    6.En condición clínica estable:
    • Sin una exacerbación clínica de la MS durante al menos los 30 días anteriores a la aleatorización (exacerbación de la MS se define como la aparición de uno o más síntomas nuevos, o empeoramiento de los síntomas preexistentes, sin asociación con fiebre ni infección, y que dura al menos 24 horas).
    7.Obtención de la firma del consentimiento informado antes del inicio de cualquier procedimiento requerido por el estudio.
    E.4Principal exclusion criteria
    1.Mujeres en periodo de lactancia.
    2.Diagnóstico de MS clasificada como primaria progresiva o secundaria progresiva o recaída progresiva.
    3.Tratamiento con
    En los 30 días previos a la aleatorización:
    •Corticosteroides sistémicos u hormona adrenocorticotropa (ACTH)
    •Tratamiento con &#946;-bloqueantes, diltiazem, verapamilo, o digoxina, por cualquier indicación
    •Vacunación, excepto vacunas vivas (véase más abajo)
    En los 3 meses previos a la aleatorización:
    •Interferón o acetato de glatiramer
    •Tratamiento inmunosupresor sistémico (ej., ciclosporina, sirolimus, ácido micofenólico)
    •Vacunación con vacunas vivas
    •Trasfusión de plasma (plasmaféresis, citoféresis)
    •Tratamiento con un fármaco en investigación (en los 3 meses previos o 5 semividas del fármaco, lo que sea mayor), excepto agentes biológicos (véase más abajo)
    En los 6 meses previos a la aleatorización:
    •Azatioprina o metotrexato
    •Natalizumab (o fracaso previo al tratamiento con natalizumab)
    •Inmunoglobulina intravenosa
    •Agentes biológicos que no reduzcan los linfocitos (ej., daclizumab)
    En cualquier momento antes de la aleatorización:
    •Cyclofosfamida, mitoxantrona, o cladribina
    •Agentes biológicos que reduzcan los linfocitos como alemtuzumab o rituximab
    4.Pacientes en tratamiento actual de una patología autoinmune diferente a la MS.
    5.Contraindicaciones de la MRI como:
    •Marcapasos, cualquier implante metálico como válvulas cardíacas artificiales, clips en aneurismas o vasos y cualquier material metálico en las áreas de alto riesgo.
    •Alergia conocida a cualquier agente de contraste con gadolinio.
    •Insuficiencia renal grave definida por un aclaramiento de creatinina < 30 mL/min según la fórmula de Cockroft-Gault.
    •Claustrofobia.
    6.Infección bacteriana o vírica actual (excepto la onicomicosis y dermatomicosis), pruebas del antígeno de superficie de hepatitis B o anticuerpos para hepatitis C positivas.
    7.Inmunodeficiencia congénita o adquirida grave o infección por el virus de la inmunodeficiencia humana (HIV) conocida.
    8.Anticuerpos negativos para el virus de varicela zoster en el momento de la selección.
    9.Historia o presencia de enfermedad maligna (excepto lesiones extirpadas quirúrgicamente de lesiones cutáneas de células basales o escamosas), enfermedad linfoproliferativa, o historia de irradiación linfoide total o trasplante de médula ósea.
    10.Diabetes tipo I o II mal controlada.
    11.Edema macular o retinopatía diabética (confirmada en los 30 días previos a la aleatorización).
    12.Historia de abuso de drogas o alcohol clínicamente significativo.
    13.Alguna de las siguientes situaciones cardiovasculares:
    •Frecuencia cardíaca en reposo (HR) < 55 bpm, medidos mediante un ECG pre-aleatorización en la Visita 3 (Día 1).
    •Infarto de miocardio en los 6 meses previos a la aleatorización o enfermedad cardíaca isquémica sintomática.
    •Historia de enfermedad valvular cardíaca previa o actual.
    •Historia de insuficiencia cardíaca previa o actual (Clase III o IV de la NYHA).
    Historia previa o actual de alteraciones del ritmo cardíaco (e.j., bloqueo cardíaco sinauricular, síndrome del seno enfermo, bloqueo auriculo-ventricular (AV) de segundo o tercer grado, bradicardia sintomática, aleteo auricular o fibrilación auricular) o tratamiento anti-arrítmico actual.
    •Historia de síncope.
    •Hipertensión arterial no controlada.
    14.Alguna de las siguientes enfermedades pulmonares:
    •Asma bronquial moderado o grave o enfermedad pulmonar obstructiva crónica (COPD) estadios II–IV, es decir, con volumen espiratorio forzado en 1 segundo (FEV1) < 70% de la capacidad vital forzada (FVC), es decir, con relación FEV1/FVC < 0.7.
    •Historia de fibrosis pulmonar (cicatrización del pulmón), histiocitosis pulmonar de células de Langerhans.
    •Historia de tuberculosis, hallazgos en la placa de Rayos X de tórax sugestivos de una tuberculosis activa o latente, en la selección o en los 3 meses previos.
    15.Pruebas de función hepática anormales definidas como elevaciones de ALT/SGPT o AST/SGOT > 2-veces el límite superior de los valores normales (ULN) o bilirrubina total > 1.5-veces ULN.
    16.Alguno de los siguientes valores de laboratorio anormales:
    •Recuento de células blancas (WBC) < 3,500/&#61549;L
    •Hemoglobina (Hb) < 10 g/dL
    •Recuento de linfocitos < 1,000/&#61549;L
    •Plaquetas < 100,000/&#61549;L
    17.Alergia conocida a alguno de los excipientes del fármaco del estudio.
    18.Presencia de otra enfermedad médica o quirúrgica clínicamente relevante, que, en opinión del investigador, pudiera poner en riesgo al paciente por su participación en el estudio.
    19.Pacientes que estén internados por orden de las autoridades judiciales o administrativas.
    20.Pacientes que sea poco probable que cumplan el protocolo, ej. actitud no cooperativa, incapacidad de asistir a las visitas de seguimiento o probabilidad conocida de que no puedan completar el estudio incluyendo una alteración mental que haga que el paciente no sea capaz de entend
    E.5 End points
    E.5.1Primary end point(s)
    •Número acumulado de nuevas lesiones intensificadas con gadolinio por paciente, registradas mediante escáner MRI ponderado en T1 en las Semanas 12, 16, 20, y 24 después del inicio del tratamiento con el fármaco del estudio.

    Este objetivo se evaluará mediante la suma del número observado de nuevas lesiones intensificadas por gadolinio en los escáneres MRI en las Semanas 12, 16, 20, y 24. Se espera detectar una reducción de 8 a 4 (50% de reducción en comparación con placebo) en el número medio acumulado de las lesiones.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Búsqueda de dosis, Tolerabilidad
    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 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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 400
    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)
    N/A- Tratamiento normal esperado.
    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 Decision2009-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-17
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