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    Summary
    EudraCT Number:2010-024423-24
    Sponsor's Protocol Code Number:AB10015
    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:2012-11-29
    Trial 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 number2010-024423-24
    A.3Full title of the trial
    A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS)
    Estudio prospectivo, Fase II, multicéntrico, randomizado, doble ciego, controlado con placebo, de grupos paralelos para comparar la eficacia y seguridad de masitinib versus placebo en el tratamiento de pacientes con esclerosis lateral amiotrófica (ELA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)
    Evaluación de masitinib en Esclerosis Lateral Amiotrófica (ELA)
    A.3.2Name or abbreviated title of the trial where available
    not applicable
    no aplicable
    A.4.1Sponsor's protocol code numberAB10015
    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 SponsorABScience
    B.1.3.4CountryFrance
    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 supportABScience
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationABScience
    B.5.2Functional name of contact pointAlain Moussy
    B.5.3 Address:
    B.5.3.1Street Address3 avenue George V
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number0033147 20 30 08
    B.5.5Fax number0033147 20 24 11
    B.5.6E-mailalain.moussy@ab-science.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 namemasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNMasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive namena
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 namemasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNMasitinib mesylate
    D.3.9.1CAS number 790299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive nameMASITINIB
    D.3.9.4EV Substance CodeSUB32266
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated tablet
    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
    patients suffering from Amyotrophic Lateral Sclerosis (ALS)
    Pacientes con esclerosis Lateral Amiotrófica (ELA)
    E.1.1.1Medical condition in easily understood language
    Amyotrophic Lateral Sclerosis (ALS)
    Esclerosis Lateral Amiotrófica
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral 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 objective is to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis
    (ALS).
    El objetivo es comparar la eficacia y seguridad de masitinib combinado con riluzol frente a placebo combinado con riluzol en el tratamiento de pacientes con esclerosis lateral amiotrófica (ELA).
    E.2.2Secondary objectives of the trial
    Primary endpoint :
    Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised at week 48
    Secondary Endpoints:
    - Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised at week 4, 8, 12 and week 36
    - Number of failure defined by a 6 point drop in the ALSFRS-R or death
    - Survival rate at week 12, 24, 36 and week 48
    - Overall survival rate
    - Cystatin C level at week 12, 24, 36, 48
    - Forced vital capacity (FVC) score at week 4, 8, 12, 24, 36 and week 48
    - Time to first tracheotomy
    - ALS SQOLquality of life scale at week 4, 8, 12, 24, 36 and week 48
    - Safety: occurrence of Adverse Events (AE), changes on clinical examination including vital signs (blood pressure,
    pulse rate) and weight, ECG and laboratory exams (biochemistry, hematology and urinalysis)
    Criterios secundarios de valoración:
    -Escala revisada de evaluación funcional de la esclerosis lateral amiotrófica (siglas en inglés, ALSFRS) en las semanas 4, 8, 12, 24 y 36.
    -Número de fracasos definidos como una disminución de 6 puntos en la escala ALSFRS-R ó fallecimiento desde la visita basal.
    -Tasa de supervivencia en las semanas 12, 24, 36 y 48.
    -Supervivencia global.
    -Nivel de cistatina C en las semanas 12, 24, 36 y 48.
    -Puntuación de la capacidad vital forzada (CVF) en las semanas 4, 8, 12, 24, 36 y 48.
    -Tiempo transcurrido hasta la primera traqueotomía.
    -Cuestionario de calidad de vida específico de la ELA en las semanas 4, 8, 12, 24, 36 y 48.
    -Seguridad: aparición de acontecimientos adversos (AA), variaciones en la exploración física incluidas las constantes vitales (presión sanguínea, pulso) y peso, ECG y pruebas analíticas (bioquímica, hematología y análisis de orina).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    INCLUSION CRITERIA:
    1. Female or male patient aged between 18 and below 80 and whose weight ≥ 50 kg
    2. Familial or sporadic ALS
    3. Patient with a verifiable diagnosis of probable or definite ALS
    4. Disease duration no longer than 36 months
    5. Patient treated with a steady regimen of riluzole (100 mg/day) for a minimum of 1 month before study entry
    6. Patient with a FVC (Forced Vital Capacity) ≥ 60%
    7. Patient with life expectancy ≥ 6 months
    8. Patient with adequate organ function at screening and baseline:
    · Absolute Neutrophils Count (ANC) ≥ 2 x 109/L
    · Hemoglobin ≥ 10 g/dL
    · Platelets (PTL) ≥ 100 x 109/L
    · AST/ALT ≤ 2.5 ULN
    · Bilirubin ≤ 1.5 ULN
    · Albuminemia ≥ 1 x LLN
    · Urea ≤ 1.5 x ULN
    · Creatinine clearance ≥ 50 mL/min (Cockcroft and Gault formula)
    · Proteinuria < 30 mg/dL on dipstick; in case of the proteinuria ≥ 30 mg/dL, 24 hours proteinuria < 1.5g/24 hours
    9. Man or woman of child bearing potential, (entering the study after a menstrual period and who have a negative
    pregnancy test) who agree to use two methods (one for the patient and one for the partner) of medically
    acceptable forms of contraception during the study and for three months after the last treatment intake
    10. Patient able and willing to comply with study procedures as per protocol
    11. Patient able to understand, and willing to sign, and date the written informed consent form at screening visit
    prior to any protocol-specific procedures
    12. patient able to understand and willing to folow the safety procedures mentioned on the patient card
    13. Patient affiliated to a social security system
    CRITERIOS DE INCLUSIÓN
    1. Pacientes, hombres o mujeres, con edades comprendidas entre 18 y 80 años, con un peso ≥ 50 kg.
    2. Pacientes que presenten ELA familiar o esporádica.
    3. Pacientes con ELA clínicamente probable o confirmada, diagnosticada de acuerdo con los criterios de El Escorial revisados de la World Federation of Neurology (Brooks, 1994).
    4. Pacientes con una duración máxima de la enfermedad de 36 meses desde la aparición de los síntomas, en la visita de selección.
    5. Pacientes tratados con una dosis estable de riluzol (100 mg/día) al menos durante los 30 días anteriores a la visita de selección.
    6. Pacientes con una CVF (capacidad vital forzada) igual o superior al 60% del valor normal pronóstico para su sexo, estatura y edad en la visita de selección.
    7. Pacientes con una esperanza de vida ≥ 6 meses.
    8. Pacientes con un funcionamiento orgánico adecuado en la visita de selección y en la visita basal:
    ? Recuento absoluto de neutrófilos (RAN) ≥ 2 x 10 elevado a 9/l
    ? Hemoglobina ≥ 10 g/dl
    ? Plaquetas (PTL) ≥ 100 x 109/l
    ? AST/ALT ≤ 2,5 x LSN
    ? Bilirrubina ≤ 1,5 x LSN
    ? Albuminemia ≥ 1 x LIN
    ? Urea ≤ 1,5 x LSN
    ? Aclaramiento de creatinina ≥ 50 ml/min (fórmula de Cockcroft y Gault).
    ? Proteinuria < 30 mg/dl en tira reactiva; en caso de proteinuria ≥ 30 mg/dl, proteinuria de 24 horas < 1,5 g/24 horas.
    9. Hombres o mujeres en edad de procrear, (que participen en el estudio una vez pasado el periodo menstrual y con una prueba de embarazo negativa) deben acceder a utilizar dos métodos anticonceptivos aceptados médicamente (uno para el paciente y el otro para la pareja) durante el estudio y en los tres meses a partir de la última toma del tratamiento.
    10. Pacientes capaces y dispuestos a seguir los procedimientos del estudio según el protocolo.
    11. Pacientes capaces de entender y dispuestos a firmar y fechar el impreso de consentimiento informado en la visita de selección antes de llevar a cabo cualquier procedimiento específico del protocolo.
    12. Pacientes capaces de entender y dispuestos a seguir los procedimientos de seguridad mencionados en la tarjeta del paciente durante los primeros 2 meses de tratamiento.
    13. Pacientes afiliados a la Seguridad Social.
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA
    1. Patient with history of cardiac, hematologic, hepatic, respiratory that is clinically significant for their
    participation in the study
    2. Patient who underwent tracheotomy and /or gastrostomy
    3. Patient with a diagnosis of cancer or evidence of continued disease within five years before starting study treatment
    4. Patient with significant sensory abnormalities, dementia, other neurologic diseases, uncompensated medical
    illness, substance abuse and psychiatric illness
    5. Patient who have participated in a clinical trial within 3 months prior to screening
    6. Pregnant, or nursing female patient
    7. Patient having cardiac disorders defined by at least one of the following conditions:
    · Patient with recent cardiac history (within 6 months) of:
    - Acute coronary syndrome
    - Acute heart failure (class III or IV of the NYHA classification)
    - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation,
    resuscitated sudden death)
    · Patient with cardiac failure class III or IV of the NYHA classification
    · Patient with severe conduction disorders which are not prevented by permanent pacing (atrioventricular
    block 2 and 3, sino-atrial block)
    · Syncope without known aetiology within 3 months
    · Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic
    hypertension
    8. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage
    consumption that would interfere with the ability to comply with the study protocol, or current or past
    psychiatric disease that might interfere with the ability to comply with the study protocol or give informed
    consent
    PREVIOUS TREATMENTS
    9. Patient treated with any investigational agent within 3 months of screening
    CRITERIOS DE EXCLUSIÓN
    1. Pacientes con antecedentes cardíacos, hematológicos, hepáticos, respiratorios que son clínicamente significativos para su participación en el estudio.
    2. Pacientes sometidos a traqueotomía y/o gastrostomía.
    3. Pacientes con diagnóstico de neoplasia maligna o indicios de una enfermedad continua en los cinco años anteriores al inicio del tratamiento del estudio.
    4. Pacientes con alteraciones sensitivas significativas, demencia, otras enfermedades neurológicas, enfermedad médica descompensada, drogadicción y enfermedades psiquiátricas.
    5. Pacientes que han participado en un ensayo clínico en los 3 meses anteriores a la visita de selección.
    6. Pacientes embarazadas o en periodo de lactancia.
    7. Pacientes con afecciones cardíacas definidas por al menos uno de los siguientes trastornos:
    ? Pacientes con antecedentes cardíacos recientes (en los 6 meses previos) de:
    - Síndrome coronario agudo.
    - Insuficiencia cardíaca aguda (clase III o IV según la clasificación de la NYHA).
    - Arritmia ventricular importante (taquicardia ventricular persistente, fibrilación ventricular, muerte súbita reanimada).
    ? Pacientes con insuficiencia cardíaca de clase III o IV según la clasificación de la NYHA.
    ? Pacientes con trastornos graves de la conducción cardíaca no evitables mediante electroestimulación cardíaca permanente (bloqueo auriculoventricular 2 y 3, bloqueo sinoauricular).
    ? Síncope sin etiología conocida en los 3 meses previos.
    ? Hipertensión grave no controlada, a juicio del investigador, o hipertensión sintomática.

    8. Pacientes con antecedentes de pobre cumplimiento o drogadicción/alcoholismo, o consumo excesivo de bebidas alcohólicas o enfermedades psiquiátricas presentes o pasadas que pudieran interferir en la capacidad para cumplir el protocolo del estudio o para dar su consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints
    Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised at week 48
    Criterio principal
    Escala revisada de evaluación funcional de la esclerosis lateral amiotrófica ( ALSFRS) en la semana 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 48
    semana 48
    E.5.2Secondary end point(s)
    Secondary endpoints
    - Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised at week 4, 8, 12, 24 and week 36
    - Number of failure deined as 6 drop point in ALSFRS-R or death
    - Survival rate at week 12, 24, 36 and week 48
    - Overall survival rate
    - Cystatin C level from baseline to week 48
    - Forced vital capacity (FVC) score at week 4, 8, 12, 24, 36 and week 48
    - Time to first tracheotomy
    - ALS SQOL quality of life scale at week 4, 8, 12, 24, 36 and week 48
    - Safety: occurrence of Adverse Events (AE), changes on clinical examination including vital signs (blood pressure,
    pulse rate) and weight, ECG and laboratory exams (biochemistry, hematology and urinalysis)
    Criterios secundarios de valoración:
    - Escala revisada de evaluación funcional de la esclerosis lateral amiotrófica (siglas en inglés, ALSFRS) en las semanas 4, 8, 12, 24 y 36.
    - Número de fracasos definidos como una disminución de 6 puntos en la escala ALSFRS-R ó fallecimiento desde la visita basal.
    - Tasa de supervivencia en las semanas 12, 24, 36 y 48.
    - Supervivencia global.
    - Nivel de cistatina C en las semanas 12, 24, 36 y 48.
    - Puntuación de la capacidad vital forzada (CVF) en las semanas 4, 8, 12, 24, 36 y 48.
    - Tiempo transcurrido hasta la primera traqueotomía.
    - Cuestionario de calidad de vida específico de la ELA en las semanas 4, 8, 12, 24, 36 y 48.
    - Seguridad: aparición de acontecimientos adversos (AA), variaciones en la exploración física incluidas las constantes vitales (presión sanguínea, pulso) y peso, ECG y pruebas analíticas (bioquímica, hematología y análisis de orina).
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 4, 8, 12, 24, 36
    semanas 4, 8, 12, 24, 36
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Study treatment will be discontinued in case of:
    · Informed consent withdrawal
    · Adverse or undercurrent event considered intolerable by the patient or incompatible with continuation of
    the study according to the investigator
    · Protocol violation (e.g., noncompliance with treatment administration, prohibited treatment needed)
    El tratamiento en estudio se suspenderá en caso de:
    - Retirada del consentimiento informado.
    - Acontecimiento adverso o subyacente considerado intolerable por el paciente o incompatible con su continuidad en el estudio según el investigador.
    - Violación de protocolo (p.ej., incumplimiento terapéutico, necesidad de seguir un tratamiento prohibido).
    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 months0
    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 months0
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    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)
    not different
    non différent
    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 Decision2013-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
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