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    Summary
    EudraCT Number:2014-001579-30
    Sponsor's Protocol Code Number:TV5600-CNS-20006
    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:2014-10-23
    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 number2014-001579-30
    A.3Full title of the trial
    A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS)
    Estudio multinacional, multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia, la seguridad y la tolerabilidad de la administración oral una vez al día de laquinimod (0,6 o 1,5 mg) en pacientes con esclerosis múltiple progresiva primaria (EMPP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) as
    compared to placebo
    Estudio clínico de fase 2 en sujetos con esclerosis múltiple progresiva para evaluar la eficacia, seguridad y tolerabilidad de dos dosis orales de laquinimod, tanto de 0.6 mg/día o de 1.5 mg/día (fármaco experimental), comparado con placebo.
    A.3.2Name or abbreviated title of the trial where available
    ARPEGGIO
    ARPEGGIO
    A.4.1Sponsor's protocol code numberTV5600-CNS-20006
    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 SponsorTeva Pharmaceutical Industries Ltd.
    B.1.3.4CountryIsrael
    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 supportTeva Pharmaceutical Industries Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressWaldeckerstrasse 7
    B.5.3.2Town/ cityMoerfelden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.4Telephone number900834223
    B.5.5Fax number000000000000
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 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 nameLaquinimod
    D.3.2Product code TV-5600
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLAQUINIMOD
    D.3.9.1CAS number 248282-07-7
    D.3.9.2Current sponsor codeTV-5600
    D.3.9.3Other descriptive nameLaquinimod Sodium (USAN)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameLaquinimod
    D.3.2Product code TV-5600
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLAQUINIMOD
    D.3.9.1CAS number 248282-07-7
    D.3.9.2Current sponsor codeTV-5600
    D.3.9.3Other descriptive nameLaquinimod Sodium (USAN)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    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
    Primary Progressive Multiple Sclerosis
    Esclerosis Múltiple Progresiva Primaria
    E.1.1.1Medical condition in easily understood language
    Primary Progressive Multiple Sclerosis (PPMS) is an autoimmune disease of the central nervous system featuring gradual worsening of neurological function without distinct exacerbations.
    Esclerosis Múltiple Progresiva Primaria(EMPP)es una enfermedad autoinmune del sistema nervioso central que manifiesta un deterioro mantenido de la función neurológica sin exacerbaciones diferenciadas
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to assess the efficacy, safety, and tolerability of a once daily oral dose of laquinimod (0.6 or 1.5 mg) compared to placebo in PPMS patients.
    Los objetivos de este estudio consisten en evaluar la eficacia, la seguridad y la tolerabilidad de una dosis oral una vez al día de laquinimod (0,6 o 1,5 mg) en comparación con placebo en pacientes con EMPP.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    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-studies (Ancillary studies) are described within the current core study protocol.
    Some of these studies may be performed only in selected sites and in accordance with local regulations as applicable.

    1. Pharmacokinetc Variables: Pharmacokinetics of laquinimod will be evaluated
    2. Potential Biomarker Measures: Potential biomarker assessments to better understand laquinimod MoA, as well as to explore response predictive markers for efficacy or safety
    3.Pharmacogenomic Variables: PGx analyses to investigate the association between genetic sequence polymorphisms and/or gene and clinical response including unexpected adverse events.
    4. Cerebrospinal fluid (CSF) assessment: to explore putative neuroprotective effects of laquinimod
    5. Optical coherence tomography (OCT) assessment: used as a tool for visualizing the processes of
    neurodegeneration, neuroprotection, and neurorepair in MS.
    Los estudios complementarios están descritos dentro del protocolo del estudio en vigor. Algunos de estos estudios pueden tener lugar sólo en determinados centros de acuerdo a la regulaciones locales aplicables.
    1. Variable farmacocinética. La farmacocinética del laquinimod será evaluada.
    2. Medida de posibles biomarcadores. Las evaluaciones de posibles biomarcadores para conocer mejor el mecanismo de acción del laquinimod, así como para investigar marcadores predictivos de la respuesta en cuanto a eficacia o seguridad.
    3. Variables farmacogenómicas: Los estudios farmacogenómicos investigan la asociación entre polimorfismos de secuencias genéticas y/ o firmas de expresión génica y la respuesta clínica a una determinada intervención terapéutica incluyendo acontecimientos adversos inesperados.
    4. Evaluación del líquido cefalorraquídeo (LCR): se investigarán supuestos efectos neuroprotectores del laquinimod.
    5. Evaluación de Tomografía de Coherencia Óptica (TCO): usada como herramienta para visualizar los procesos de neurodegenración, neuroprotección y neuroreparación en Esclerosis Múltiple (EM).
    E.3Principal inclusion criteria
    1. Patients must have a confirmed and documented PPMS diagnosis as defined by the current valid McDonald criteria
    2. Baseline magnetic resonance imaging (MRI) showing lesions consistent with PPMS in either or both brain and spinal cord
    3. Patients must have an Expanded Disability Status Scale (EDSS) score of 3 to 6.5, inclusive, at both
    screening and baseline visits
    4. Documented evidence of clinical disability progression in the 2 years prior to screening.
    5. Functional System Score (FSS) of > or equal 2 for the pyramidal system or gait impairment due to lower extremity dysfunction
    6. Patients must be between 25 to 55 years of age, inclusive
    7. Women of child-bearing potential must practice an acceptable method of birth control for 30 days before taking the study drug, and 2 acceptable methods of birth control during all study duration and until 30 days after the last dose of treatment is administered.
    8. Patients must sign and date a written informed consent prior to entering the study.
    9. Patients must be willing and able to comply with the protocol requirements for the duration of the study.
    1. Los pacientes deben tener un diagnóstico confirmado y documentado de EMPP conforme a lo definido por los criterios de McDonald actualmente validados.
    2. Resonancia magnética (RM) basal en la que se aprecian lesiones compatibles con EMPP en el cerebro, la médula espinal o ambos.
    3. Pacientes con puntuación EDSS (Escala ampliada del estado de discapacidad) de 3 a 6,5, ambos inclusive, en las visitas de selección y basal.
    4. Pruebas documentadas de progresión clínica de la discapacidad en los 2 años previos a la selección.
    5. Puntuación FSS (Puntuación de sistemas funcionales) > o igual a 2 en relación con el sistema piramidal o deterioro de la marcha por disfunción de las extremidades inferiores.
    6. Pacientes con edad comprendida entre los 25 y 55 años, ambos inclusive.
    7. Las mujeres en edad fértil deberán utilizar un método anticonceptivo aceptable durante 30 días antes de tomar el fármaco del estudio, así como 2 métodos anticonceptivos aceptables durante todo el estudio y hasta 30 días después de administrar la última dosis del tratamiento.
    8. Firma con fecha de un consentimiento informado por escrito por parte del paciente antes de incorporarse el estudio.
    9. Disposición y capacidad del paciente de cumplir los requisitos del protocolo durante el estudio.
    E.4Principal exclusion criteria
    1. Patients with history of any multiple sclerosis (MS) exacerbations or relapses, including any episodes of optic neuritis.
    2. Progressive neurological disorder other than PPMS.
    3. Any MRI record showing presence of cervical cord compression.
    4. Baseline MRI showing other findings (including lesions that are atypical for PPMS) that may explain the clinical signs and symptoms.
    5. Relevant history of vitamin B12 deficiency.
    6. Positive human T-lymphotropic virus Type I and II (HTLV-I/II) serology.
    7. Use of experimental or investigational drugs in a clinical study within 24 weeks prior to baseline. Use of a currently marketed drug in a clinical study within 24 weeks prior to baseline would not be exclusionary, provided no other exclusion criteria are met.
    8. Use of immunosuppressive agents, or cytotoxic agents, including cyclophosphamide and azathioprine
    within 48 weeks prior to baseline.
    9. Previous treatment with fingolimod (GILENYA®, Novartis), dimethyl fumarate (TECFIDERA®, Biogen
    Idec Inc), glatiramer acetate (COPAXONE®, Teva), interferon-beta (either 1a or 1b), intravenous
    immunoglobulin, or plasmapheresis within 8 weeks prior to baseline.
    10. Use of teriflunomide (AUBAGIO®, Sanofi) within 2 years prior to baseline, except if active washout (with either cholestyramine or activated charcoal) was done 2 months or more prior to baseline.
    11. Prior use of monoclonal antibodies ever, except for:
    a. natalizumab (TYSABRI®, Biogen Idec Inc), if given more than 24 weeks prior to baseline AND the
    patient is John Cunningham (JC) virus antibody test negative (as per medical history)
    b. rituximab, ocrelizumab, or ofatumumab, if B cell count (CD19, as per medical history) is higher than
    80 cells/microL
    12. Use of mitoxantrone (NOVANTRONE®, Immunex) within 5 years prior to screening. Use of mitoxantrone >5 years before screening is allowed in patients with normal ejection fraction and who did not exceed the total lifetime maximal dose.
    13. Previous use of laquinimod.
    14. Chronic (eg, more than 30 consecutive days or monthly dosing, with the intent of MS disease modification) systemic (intravenous, intramuscular or oral) corticosteroid treatment within 8 weeks prior to baseline.
    15. Previous use of cladribine or alemtuzumab (LEMTRADA®, Sanofi).
    16. Previous total body irradiation or total lymphoid irradiation.
    17. Previous stem cell treatment, cell-based treatment, or bone marrow transplantation of any kind.
    18. Patients who underwent endovascular treatment for chronic cerebrospinal venous insufficiency (CCSVI) within 12 weeks prior to baseline.
    19. Use of moderate/strong inhibitors of cytochrome P450 (CYP) 3A4 within 2 weeks prior to baseline.
    20. Use of inducers of CYP3A4 within 2 weeks prior to baseline.
    21. Pregnancy or breastfeeding.
    22. Serum levels >=3× upper limit of the normal range (ULN) of either alanine aminotransferase (ALT) or
    aspartate aminotransferase (AST) at screening.
    23. Serum direct bilirubin which is >=2×ULN at screening.
    24. Patients with a clinically significant or unstable medical or surgical condition that (in the opinion of the Investigator) would preclude safe and complete study participation, as determined by medical history, physical examinations, electrocardiogram (ECG), laboratory tests or chest X-ray.
    25. A known history of hypersensitivity to gadolinium (Gd).
    26. Glomerular filtration rate (GFR) < or equal 60 mL/min at screening visit.
    27. Inability to successfully undergo MRI scanning, including claustrophobia.
    28. Known drug hypersensitivity that would preclude administration of laquinimod, such as hypersensitivity to mannitol, meglumine or sodium stearyl fumarate.
    1. Pacientes con antecedentes de cualquier exacerbación o recidiva de la esclerosis múltiple (EM), incluido cualquier episodio de neuritis óptica.
    2. Trastorno neurológico progresivo diferente de la EMPP.
    3. Cualquier registro de RM que demuestre la presencia de compresión medular cervical.
    4. Resonancia Magnética (RM) basal que muestre otros hallazgos (incluidas lesiones atípicas de EMPP) que puedan explicar los signos y síntomas clínicos.
    5. Antecedentes relevantes de carencia de vitamina B12.
    6. Serología positiva para el virus linfótropo T humano de tipo I y II (HTLV-I/II).
    7. Uso de fármacos experimentales o en investigación en un estudio clínico en las 24 semanas previas a la visita basal. El uso de un fármaco ya comercializado en un estudio clínico en las 24 semanas previas a la visita basal no es un criterio de exclusión, siempre que no se cumplan otros criterios de exclusión.
    8. Uso de inmunodepresores o citotóxicos, como ciclofosfamida y azatioprina, en las 48 semanas previas a la visita basal.
    9. Tratamiento previo con fingolimod (GILENYA®, Novartis), dimetil fumarato (TECFIDERA®, Biogen Idec Inc), acetato de glatirámero (COPAXONE®, Teva), interferón-beta (1a o 1b), inmunoglobulina intravenosa o plasmaféresis en las 8 semanas previas a la visita basal.
    10. Uso de teriflunomida (AUBAGIO®, Sanofi) en los dos años previos a la visita basal, excepto si se ha realizado un lavado activo (con colestiramina o carbón activado) dos meses o más antes de la visita basal.
    11. Uso previo de anticuerpos monoclonales, excepto:
    a. Natalizumab (TYSABRI®, Biogen Idec Inc), si se administra más de 24 semanas antes de la visita basal Y el paciente da negativo en un análisis de anticuerpos contra el virus de John Cunningham (JC) (según los antecedentes médicos).
    b. Rituximab, ocrelizumab u ofatumumab, si el recuento de linfocitos B (CD19, según los antecedents médicos) es superior a 80 células/microlitro.
    12. Uso de mitoxantrona (NOVANTRONE®, Immunex) en los 5 años previos a la visita de selección. Se permitirá el uso de mitoxantrona > 5 años antes de la visita de selección en pacientes con una fracción de eyección normal y que no hayan superado la dosis máxima total durante toda la vida.
    13. Uso previo de laquinimod.
    14. Tratamiento crónico (por ejemplo, más de 30 días consecutivos o administración mensual, con intención modificadora de la enfermedad [EM]) con corticosteroides sistémicos (por vía intravenosa, intramuscular u oral) en las 8 semanas previas a la visita basal.
    15. Uso previo de cladribina o alemtuzumab (LEMTRADA®, Sanofi).
    16. Irradiación corporal total o irradiación linfoide total previa.
    17. Tratamiento con células madre, terapia celular o trasplante de médula ósea de cualquier tipo previo.
    18. Tratamiento endovascular de una insuficiencia venosa cefalorraquídea crónica (IVCRC) en las 12 semanas previas a la visita basal.
    19. Uso de inhibidores moderados o potentes de la enzima 3A4 del citocromo P450 (CYP3A4) en las 2 semanas previas a la visita basal.
    20. Uso de inductores de la enzima CYP3A4 en las 2 semanas previas a la visita basal.
    21. Embarazo o lactancia.
    22. Concentraciones séricas >= 3 veces el límite superior de la normalidad (LSN) de alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) en la visita de selección.
    23. Bilirrubina directa en suero >= 2 veces el LSN en la visita de selección.
    24. Trastorno médico o quirúrgico clínicamente importante o inestable que, en opinión del investigador, impida una participación segura y completa en el estudio, conforme a lo determinado a partir de los antecedents médicos, exploraciones físicas, electrocardiogramas (ECG), pruebas analíticas o radiografías de tórax.
    25. Antecedentes de hipersensibilidad al gadolinio (Gd).
    26. Filtración glomerular (FG) < o igual a 60 ml/min en la visita de selección.
    27. Incapacidad para someterse con éxito a una RM, incluida la claustrofobia.
    28. Hipersensibilidad conocida a fármacos que impida la administración de laquinimod, como hipersensibilidad a manitol, meglumina o estearil fumarato de sodio.
    E.5 End points
    E.5.1Primary end point(s)
    Brain atrophy (BA), defined as change in brain volume
    Atrofia cerebral (AC), definida por la variación del volumen cerebral
    E.5.1.1Timepoint(s) of evaluation of this end point
    Percentage in Brain Volume Change (PBVC) from baseline to week 48
    Variación porcentual del volumen cerebral entre el momento basal y la semana 48.
    E.5.2Secondary end point(s)
    -Time to CDP (confirmed disability progression) defined by an increase in baseline EDSS
    -Time to CDP defined by an increase in baseline EDSS or at least a 20% worsening in the Timed 25 Foot Walk
    - The number of new T2 brain lesions
    -Change in the BICAMS (Cognitive Assessment for Multiple Sclerosis score)
    - Tiempo transcurrido hasta la progresión confirmada de la discapacidad (PCD), definida como un aumento de la puntuación EDSS basal
    - Tiempo transcurrido hasta la PCD definida por un aumento de la puntuación EDSS basal o un aumento de un 20%, como mínimo con respecto a la puntuación Prueba de marcha cronometrada de 25 pies (T25FW).
    - Número de lesiones cerebrales nuevas en T2.
    - Variación de la puntuación BICAMS entre el momento basal y la semana 48.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Time to confirmed disability progression (CDP), to be confirmed after at least 12 weeks
    -An increase from baseline in EDSS score confirmed after at least 12 weeks
    -An increase of at least 20% from baseline in T25FW score, confirmed after at least 12 weeks
    -The number of new T2 brain lesions at week 48
    -Change from baseline to week 48 in the BICAMS score
    - Tiempo transcurrido hasta la progresión confirmada de la discapacidad (PCD), confirmado al cabo de al menos 12 semanas.
    - Aumento con respecto a la puntuación EDSS basal confirmado al cabo de al menos 12 semanas
    - Aumento de un 20 %, como mínimo, con respecto a la puntuación T25FW basal, confirmado al cabo de al menos 12 semanas.
    - Número de lesiones cerebrales nuevas en T2 en la semana 48.
    - Variación de la puntuación BICAMS entre el momento basal y la semana 48.
    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 Yes
    E.6.10Pharmacogenetic Yes
    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 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.8.2.4Number of treatment arms in the trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Germany
    Italy
    Netherlands
    Poland
    Russian Federation
    Spain
    Ukraine
    United Kingdom
    United States
    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
    Last visit last subject (LVLS)
    Última visita último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 375
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 211
    F.4.2.2In the whole clinical trial 375
    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)
    Standard of care treatment
    Tratamiento estandar
    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 Decision2014-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-01
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