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    Summary
    EudraCT Number:2011-004853-18
    Sponsor's Protocol Code Number:PTC124-GD-019-DMD
    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:2012-04-17
    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 number2011-004853-18
    A.3Full title of the trial
    An Open-Label Study for Previously Treated Ataluren (PTC124®) Patients with Nonsense Mutation Dystrophinopathy
    Estudio Abierto para pacientes con Distrofinopatía por Mutación sin Sentido Tratados Previamente con Atalureno (PTC124®)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of ataluren in patients with Nonsense Mutation Duchenne and Becker muscular dystrophy
    Estudio con atalureno en pacientes con distrofinopatía de Duchenne y Becker por mutación sin sentido.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberPTC124-GD-019-DMD
    A.5.4Other Identifiers
    Name:INDNumber:68,431
    Name:NCTNumber:01557400
    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 SponsorPTC Therapeutics, Inc
    B.1.3.4CountryUnited States
    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 supportPTC Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVoisin Consulting
    B.5.2Functional name of contact pointClinical Trial Unit
    B.5.3 Address:
    B.5.3.1Street Address3 rue des Longs Prés
    B.5.3.2Town/ cityBoulogne-Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.6E-mailclinicaltrialinformation@voisinconsulting.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/278
    D.3 Description of the IMP
    D.3.1Product nameataluren
    D.3.2Product code PTC124
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNataluren
    D.3.9.1CAS number 775304-57-9
    D.3.9.2Current sponsor codePTC124
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/278
    D.3 Description of the IMP
    D.3.1Product nameataluren
    D.3.2Product code PTC124
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNataluren
    D.3.9.1CAS number 775304-57-9
    D.3.9.2Current sponsor codePTC124
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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: 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/278
    D.3 Description of the IMP
    D.3.1Product nameataluren
    D.3.2Product code PTC124
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNataluren
    D.3.9.1CAS number 775304-57-9
    D.3.9.2Current sponsor codePTC124
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nonsense mutation dystrophinopathy
    Distrofinopatía por mutación sin sentido
    E.1.1.1Medical condition in easily understood language
    Duchenne and Becker muscular dystrophy (muscle diseases that weaken the musculoskeletal system)
    Distrofia muscular de Duchenne y Becker (enfermedad muscular que debilita el sistema musculoesquelético)
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10013801
    E.1.2Term Duchenne muscular dystrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10059117
    E.1.2Term Becker's muscular dystrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety and tolerability of 10, 10, 20 mg/kg ataluren in patients with nmDBMD who had prior exposure to ataluren in a PTC-sponsored clinical trial.
    El objetivo principal de valoración de este estudio es evaluar la seguridad y tolerabilidad de 10, 10 y 20 mg/kg de atalureno en pacientes con DMDBmss que habían recibido atalureno previamente en un estudio clínico patrocinado por PTC.
    E.2.2Secondary objectives of the trial
    - Ambulatory patients (able to run/walk 10 meters in ?30 seconds): To determine the effect of ataluren on ambulation and other aspects of physical function
    - Nonambulatory patients (unable to run/walk 10 meters in ?30 seconds): To assess the effect of ataluren on activities of daily living, upper limb function, and pulmonary function
    - All patients: To assess patient and/or parent/caregiver reports of changes in disease status:
    * Retrospectively during and after participation in previous studies (Studies 007 and 007e)
    * Prospectively during the current study
    - En pacientes con capacidad de deambulación (capaces de correr o caminar 10 metros en ?30 segundos: determinación del efecto de atalureno en la deambulación y otros aspectos de la función física
    - En pacientes que no deambulen (incapaces de correr o caminar 10 metros en ?30 segundos): se evaluará el efecto de atalureno en las actividades cotidianas, función pulmonar y de los miembros superiores
    - En todos los pacientes se evaluarán los cambios en los informes del estado de la enfermedad comunicados por el paciente o por el padre o cuidador
    * Retrospectivamente durante y después de la participación en los estudios anteriores (estudios 007 y 007e)
    * Prospectivamente durante el estudio actual
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of signed and dated informed consent/assent document(s) indicating that the subject (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial.
    2. History of exposure to ataluren in a prior PTC study in nmDBMD. Note: Subjects who have participated in a prior or ongoing PTC study with ataluren in nmDBMD at a trial site in the US or Canada, but reside outside of the US and Canada, may be eligible for this study (with the approval of the PTC Therapeutics Medical Monitor).
    3. Male sex.
    4. Confirmed screening laboratory values within the central laboratory ranges specified in the protocol.
    5. In patients who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during ataluren administration and the 6-week follow-up period.
    6. Willingness and ability to comply with scheduled visits, drug administration plan, study procedures, laboratory tests, and study restrictions.
    1. Prueba de un documento de consentimiento/asentimiento informado firmado y fechado en el que se indique que el paciente (y sus padres o tutor legal) han sido informados de todos los aspectos pertinentes del estudio
    2. Antecedentes de exposición a atalureno en un estudio previo de PTC en DMDBmss. Nota: Los pacientes se consideran elegibles sólo si recibieron atalureno durante su participación en uno o más de los estudios previos patrocinados por PTC sobre atalureno en la DMDBmss. Nota: Los sujetos que hayan participado en un estudio previo o en curso de PTC con atalureno en la DMDBmss en un centro de estudio de EE. UU. o Canadá, pero que residan fuera de esos países, pueden considerarse aptos para este estudio (con la aprobación del monitor médico de PTC Therapeutics).
    3. Sexo masculino.
    4. Valores analíticos confirmados en el período de selección dentro de los intervalos del laboratorio central que se especifican en la Tabla 2 siguiente. Nota: Se deben confirmar los valores fuera del intervalo para determinar si la anomalía es real o si es un artefacto. Los valores utilizados para establecer la elegibilidad deben ser los obtenidos en la última medición efectuada en el período de selección.
    5. En pacientes sexualmente activos, disposición a mantener la abstinencia sexual o a utilizar un método anticonceptivo de barrera u otro método anticonceptivo médicamente aceptado durante la administración de atalureno y durante el período de seguimiento de 6 semanas.
    6. Pacientes dispuestos y capaces de cumplir con las visitas programadas, el plan de administración del fármaco del estudio, los procedimientos del estudio, las pruebas analíticas y las restricciones del estudio.
    E.4Principal exclusion criteria
    1. Exposure to another investigational drug within 1 month prior to start of study treatment.
    2. Eligibility for another ataluren clinical trial that is actively enrolling study participants.
    3. Known hypersensitivity to any of the ingredients or excipients of ataluren (Litesse® UltraTM
    [refined polydextrose], polyethylene glycol 3350, Lutrol® micro F127 [poloxamer 407], mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, vanilla, Cab-O-Sil® M5P
    [colloidal silica], magnesium stearate).
    4. Ongoing use of the following medications:
    a. Coumarin based anticoagulants (eg, warfarin), phenytoin, tolbutamide, or paclitaxel.
    b. Systemic aminoglycoside therapy.
    5. Ongoing uncontrolled medical/surgical condition, ECG findings, or laboratory abnormality that, in the investigator?s opinion, could adversely affect the safety of the patient or make it unlikely that follow-up would be completed.
    1. Exposición a cualquier otro producto en investigación en el mes anterior al comienzo del tratamiento del ensayo.
    2. Candidato a otro estudio clínico con atalureno que se encuentre en fase activa de inclusión de pacientes.
    3. Hipersensibilidad conocida a cualquiera de los ingredientes o excipientes de atalureno (Litesse® UltraTM [polidextrosa refinada], polietilenglicol 3350, Lutrol® micro F127 [poloxámero 407], mannitol 25C, crospovidona XL10, hidroxietil celulosa, vainilla, Cab-O-Sil® M5P [sílice coloidal], estearata de magnesio).
    4. Uso actual de los siguientes medicamentos:
    a. Anticoagulantes cumarínicos (como warfarina), fenitoína, tolbutamida o paclitaxel.
    b. Tratamiento sistémico con aminoglucósidos
    5. Afección médica o quirúrgica en curso no controlada, hallazgos en el ECG o anomalías analíticas que, en opinión del investigador, pudieran afectar negativamente a la seguridad del paciente o hacer improbable la terminación del seguimiento.
    E.5 End points
    E.5.1Primary end point(s)
    Safety profile characterized by type, frequency, severity, timing, and relationship to ataluren of any adverse events or laboratory abnormalities.
    Perfil de seguridad caracterizada por tipo, frecuencia, gravedad, tiempo y relación con atalureno de acontecimientos adversos o anormalidades de laboratorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 12 weeks
    Cada 12 semanas
    E.5.2Secondary end point(s)
    - In ambulatory patients, change from baseline in 6MWD as measured by the 6-minute walk
    test (6MWT)
    -In ambulatory patients, change from baseline in physical function as measured by the North Star Ambulatory Assessment (NSAA)
    - In ambulatory patients, change from baseline in timed function tests (time to stand from supine and time to run/walk 10 meters)
    - In nonambulatory patients, change from baseline in pulmonary function as measured by spirometry
    - In nonambulatory patients, change from baseline in patient and parent/caregiver-reported activities of daily living, as measured by the Egen Klassifikation (EK) scale
    -In all patients, changes in patient and/or parent/caregiver reports of disease status as measured by a standardized survey administered by site personnel
    - En pacientes ambulatorios, cambio desde el periodo basal en la distancia caminada en 6 minutos (DC6M)
    - En pacientes ambulatorios, desde el periodo basal en función física medida por la Evaluación de la Deambulación de North Star (NSAA)
    - En pacientes ambulatorios, cambio respecto al período basal en las pruebas funcionales cronometradas (tiempo en levantarse desde el decúbito supino y tiempo en correr o caminar 10 metros)
    - En pacientes no ambulatorios, cambios respecto al periodo basal de la función pulmonar medida por espirometría
    - En pacientes no ambulatorios, cambios respecto al período basal en las actividades cotidianas comunicadas por el sujeto y el padre o cuidador, medidas aplicando la escala de clasificación de Egen (EK)
    -En todos los pacientes, los cambios en los informes del estado de la enfermedad comunicados por el paciente o por el padre o cuidador, utilizando una encuesta estandarizada administrada por el personal del centro.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6MWT: Screening Visit, Week 24, Week 48
    NSAA: Screening, Week 48
    Timed function test: Screening, Week 48
    Spirometry: Screening, Week 24, Week 48
    EK Scale: Screening Visit, Week 48
    Disease status survey: Screening, Week 12, Week 24, Week 36 and Week 48
    DC6M: Visita de Screening , Semana 24, Semana 48
    NSAA: Screening, Semana 48
    Pruebas funcionales cronometradas: Screening, Semana 48
    Espirometría: Screening, Semana 24, Semana 48
    Escala EK: Visita de Screening, Semana 48
    Encuesta sobre el estado de la enfermedad: Screening, Semana 12, Semana 24, Semana 36 y 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    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 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
    Australia
    Canada
    Israel
    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
    LVLS
    LVLS
    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 Yes
    F.1.1Number of subjects for this age range: 94
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 52
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 42
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 96
    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)
    Expected normal treatment of the condition
    Tratamiento habitual para esta efermedad
    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 Decision2012-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-19
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