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    Summary
    EudraCT Number:2010-019692-30
    Sponsor's Protocol Code Number:PTC124-GD-009e-CF
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-07-29
    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 number2010-019692-30
    A.3Full title of the trial
    A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis
    Estudio de extensión de fase 3 de ataluren (PTC124) en pacientes con fibrosis quística mediada por mutación terminadora
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension study of ataluren in patients with Cystic Fibrosis
    Estudio de extensión de ataluren en pacientes con fibrosis quística
    A.4.1Sponsor's protocol code numberPTC124-GD-009e-CF
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00803205
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/106/2011
    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 Operations Europe
    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/3/05/277
    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/3/05/277
    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/3/05/277
    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-Mediated Cystic Fibrosis
    Fibrosis quística mediada por mutación terminadora
    E.1.1.1Medical condition in easily understood language
    Enfermedad genética que se caracteriza por dificultad respiratoria. Otros síntomas son la disfunción de páncreas, hígado, vías biliares e intestino, así como descenso de la fertilidad.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    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
    The primary objective of this study is to evaluate the long-term safety of ataluren in patients with nmCF, as determined by adverse events and laboratory abnormalities.
    El principal objetivo de este estudio es evaluar la seguridad a largo plazo de ataluren en pacientes con FQmt, determinada por los acontecimientos adversos y las anomalías en los valores de laboratorio
    E.2.2Secondary objectives of the trial
    The secondary objectives provide a comprehensive evaluation of the effects of ataluren on major clinical manifestations of CF and on the pathophysiology of the disease, and include the following:
    - To determine the long-term effect of ataluren on pulmonary function
    - To determine the long-term effect of ataluren on pulmonary exacerbation
    - To determine the long-term effect of ataluren on medical interventions
    - To determine the long-term effect of ataluren on health-related quality of life (HRQL)
    - To determine the long-term effect of ataluren on general well-being
    - To determine the long-term effect of ataluren on CF pulmonary pathology
    - To evaluate the long-term pharmacologic activity of ataluren in CF
    - To determine long-term compliance with ataluren therapy
    - To assess long-term ataluren plasma exposure
    Los objetivos secundarios proporcionan una evaluación exhaustiva de los efectos de ataluren en las principales manifestaciones clínicas de la FQ y en la fisiopatología de la enfermedad, e incluyen los siguientes:
    - Determinar el efecto a largo plazo de ataluren en la función pulmonar.
    - Determinar el efecto a largo plazo de ataluren en la exacerbación pulmonar.
    - Determinar el efecto a largo plazo de ataluren en las intervenciones médicas.
    - Determinar el efecto a largo plazo de ataluren en la calidad de vida relacionada con la salud (CVRS).
    - Determinar el efecto a largo plazo de ataluren en el bienestar general.
    - Determinar el efecto a largo plazo de ataluren en la patología de FQ pulmonar.
    - Evaluar la actividad farmacológica a largo plazo de ataluren en la FQ.
    - Determinar el cumplimiento del tratamiento con ataluren a largo plazo.
    - Evaluar la exposición plasmática a ataluren a largo plazo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completion of ~48 weeks of blinded study drug treatment in the previous Phase 3 study (Study PTC124-GD-009-CF).
    2. Evidence of signed and dated informed consent/assent document(s) indicating that the subject (and/or his/her parent/legal guardian) has been informed of all pertinent aspects of the study. Note: If the study candidate is considered a child under local regulation, a parent or legal guardian must provide written consent prior to initiation of study screening procedures and the study candidate may be required to provide written assent.
    The rules of the responsible Institutional Review Board/Institutional Ethics Committee (IRB/IEC) regarding whether one or both parents must provide consent and the appropriate ages for obtaining consent and assent from the subject should be followed.
    3. In subjects who are sexually active, willingness to abstain from sexual intercourse or employ a highly effective barrier or medical method of contraception during ataluren administration and within 60 days of the last administration of the study drug.
    4. Willingness and ability to comply with scheduled visits, ataluren administration plan, study procedures, laboratory tests, and study restrictions.
    1. Finalización de aproximadamente 48 semanas de tratamiento enmascarado con el fármaco del estudio en el estudio de fase 3 previo (estudio PTC124-GD-009-CF).
    2. Constancia del documento o documentos de consentimiento/asentimiento informado firmados y fechados en los que se indique que el sujeto (y/o su padre/madre/tutor legal) ha sido informado de todos los aspectos pertinentes del estudio. Nota: Si, a tenor de lo dispuesto en las normativas locales, se considera que el candidato al estudio es un menor, uno de los padres o el tutor legal tiene que proporcionar un consentimiento escrito antes de que empiecen los procedimientos de selección del estudio, y podría exigirse que el candidato al estudio proporcione un asentimiento por escrito. Se deben seguir las reglas del Comité Ético de Investigación Clínica (CEIC) responsable que establecen si deben dar el consentimiento uno o los dos padres y cuáles son las edades correspondientes para la obtención del consentimiento y del asentimiento del sujeto.
    3. Sujetos sexualmente activos: estar dispuestos a abstenerse de mantener relaciones sexuales o a utilizar un método anticonceptivo de barrera o médico altamente eficaz durante la administración de ataluren y los 60 días posteriores a la última administración del fármaco del estudio.
    4. Estar dispuesto y ser capaz de cumplir con las visitas programadas, el plan de administración de ataluren, los procedimientos del estudio, las pruebas analíticas y las restricciones del estudio.
    E.4Principal exclusion criteria
    1. Known hypersensitivity to any of the ingredients or excipients of the study drug (polydextrose, polyethylene glycol 3350, poloxamer 407, mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, vanilla, colloidal silica, magnesium stearate).
    2. Current pregnancy or lactating, or pregnancy or lactating during the preceding Phase 3 study (Study PTC124-GD-009-CF).
    3. Ongoing participation in any other therapeutic clinical trial.
    4. Prior or ongoing medical condition (eg, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator?s opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
    1. Hipersensibilidad conocida a cualquiera de los ingredientes o excipientes del fármaco del estudio (polidextrosa, polietilenglicol 3350, poloxámero 407, manitol 25C, crospovidona XL10, hidroxietil celulosa, vainilla, sílice coloidal o estearato de magnesio).
    2. Embarazo o lactancia actuales, o embarazo o lactancia durante el estudio de fase 3 anterior (estudio PTC124-GD-009-CF).
    3. Participación actual en algún otro ensayo clínico terapéutico.
    4. Afección médica anterior o en curso (p. ej.: enfermedad concomitante, trastorno psiquiátrico, trastorno conductual, alcoholismo, abuso de drogas), antecedentes médicos, datos obtenidos en la exploración física o en los ECG, o anomalía en los valores de laboratorio que, según la opinión del investigador, podrían afectar de forma adversa la seguridad del sujeto, que hacen improbable que el ciclo de tratamiento o el seguimiento sean completados, o que podrían afectar la evaluación de los resultados del estudio
    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 caracterizado por el tipo, la frecuencia, la gravedad, la cronología y la relación de ataluren con cualquier acontecimiento adverso o anomalía en los valores de laboratorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events will be assessed at each onsite study visit.
    Laboratory abnormalities will be assessed at each study visit, from visit 1 to the post-treatment follow-up, based on the schedule of assessments.
    Los acontecimientos adversos se evaluarán en cada visita del estudio en el centro.
    Las anomalías analíticas se evaluarán en cada visita del estudio, desde la visita 1 a la visita de seguimiento después del tratamiento según el calendario de evaluaciones
    E.5.2Secondary end point(s)
    - Forced expiratory volume in 1 second (FEV1)
    - Forced vital capacity (FVC)
    - Incidence, rate, severity, and duration of pulmonary exacerbations
    - Respiratory HRQL as assessed by the CFQ-R respiratory domain
    - Compliance with study drug treatment
    - Ataluren plasma exposure
    - Antibiotic use and hospitalization due to CF-related symptoms
    - Disruptions to school or work due to CF-related symptoms
    - Body weight
    - Lung computerized tomography CF score
    - Nasal transepithelial potential difference (TEPD)
    - Sweat chloride concentration
    - Volumen espiratorio forzado en 1 segundo (FEV1)
    - Capacidad vital forzada (CVF)
    - Incidencia, frecuencia, intensidad y duración de las exacerbaciones pulmonares
    - CDVRS respiratoria, evaluada por el dominio respiratorio del CFQ-R
    - Cumplimiento con el tratamiento con el fármaco del estudio
    - Exposición plasmática a ataluren
    - Uso de antibióticos y hospitalización debido a síntomas relacionados con la FQ
    - Absentismo escolar y laboral debido a síntomas relacionados con la FQ
    - Peso corporal
    - Puntuación de FQ en la tomografía computerizada pulmonar
    - Diferencia de potencial transepitelial nasal (TEPD)
    - Concentración de cloruros en sudor
    E.5.2.1Timepoint(s) of evaluation of this end point
    All measures and laboratory values will be collected at the relevant study visits, from visit 1 to the post-treatment follow-up, based on the schedule of assessments.
    CFQ-R will be administered before treatment to establish a baseline and then every 8 to 16 weeks throughout the study.
    Ataluren compliance will be assessed at visits 1 through 13.
    Pre-dose (trough) ataluren plasma concentrations will be assessed prior to morning ataluren administration at each clinic visit.
    Se obtendrán las mediciones y resultados analíticos en las visitas relevantes del estudio, desde la visita 1 a la visita de seguimiento después del tratamiento según el calendario de evaluaciones.
    El CFQ-R se administrará antes del tratamiento para establecer un valor basal y después cada 8 a 16 semanas durante todo el estudio.
    El cumplimiento de ataluren se evaluará en las visitas 1 a 13.
    Las concentraciones plasmáticas de ataluren antes de la siguiente administración (mínimas) se evaluarán antes de la administración matutina de ataluren en cada visita.
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 EEA16
    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
    Israel
    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 of the last subject
    Última visita del 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 years3
    E.8.9.2In all countries concerned by the trial months5
    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: 62
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 13
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 49
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 151
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors
    Menores
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 101
    F.4.2.2In the whole clinical trial 200
    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)
    The study is planned for 96 weeks and may be further extended by amendment until either ataluren becomes commercially available or the clinical development of ataluren in nmCF is discontinued. The subjects that have ended participation in the trial will resume appropriate medical care for their condition, as determined by their treating physicians.
    El estudio está programado para realizarse en 96 semanas y después podría ampliarse mediante una enmienda, hasta que ataluren se comercialice o hasta que se termine el desarrollo clínico de ataluren en la FQnm. Los sujetos que terminen su participación en el estudio reiniciarán el tratamiento médico adecuado para su enfermedad, según determine su médico.
    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 Decision2011-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-23
    P. End of Trial
    P.End of Trial StatusOngoing
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