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    Summary
    EudraCT Number:2013-005489-20
    Sponsor's Protocol Code Number:PTC124-GD-020e-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:2014-08-06
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-005489-20
    A.3Full title of the trial
    A Phase 3 Extension Study of Ataluren (PTC124) in Patients with Nonsense Mutation Dystrophinopathy
    Estudio de extensión de fase 3 del Atalureno (PTC124) en pacientes con distrofinopatía 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 nonsense mutation Duchenne and Becker muscular dystrophy
    Estudio de extensión del Atalureno en pacientes con distrofia muscular de Duchenne y de Becker por mutación terminadora
    A.4.1Sponsor's protocol code numberPTC124-GD-020e-DMD
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02090959
    A.5.4Other Identifiers
    Name:IND NumberNumber:68431
    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 Operations
    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.5.4Telephone number+3491853 41 05
    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.3.9.4EV Substance CodeSUB89249
    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.3.9.4EV Substance CodeSUB89249
    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.3.9.4EV Substance CodeSUB89249
    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 terminadora
    E.1.1.1Medical condition in easily understood language
    Duchenne and Becker muscular dystrophy
    Distrofia muscular de Duchenne y de Becker
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 17.0
    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 evaluate the long-term safety of ataluren in boys with nonsense mutation dystrophinopathy, as determined by adverse events and laboratory abnormalities.
    Evaluar la seguridad a largo plazo de atalureno en niños varones con distrofinopatía por mutación terminadora, conforme se determine mediante los acontecimientos adversos y las alteraciones en los análisis.
    E.2.2Secondary objectives of the trial
    Physical:
    ? To determine the effect of ataluren on ambulation in subjects who are ambulatory
    ? To evaluate the effect of ataluren on proximal muscle function in subjects who are able to perform timed function tests
    ? To evaluate the effect of ataluren on physical function in subjects who are able to perform the North Star Ambulatory Assessment
    ? To evaluate the effect of ataluren on upper limb function
    Pulmonary function:
    ? To evaluate the effect of ataluren on pulmonary function
    Patient-reported outcomes:
    ? To determine the effect of ataluren on health-related quality of life (HRQL) as reported by subjects and parents/caregivers
    ? To assess the effect of ataluren on activities of daily living
    Exposure:
    ? To assess long-term ataluren plasma exposure
    Físicos:
    ? Determinar el efecto de atalureno sobre la deambulación de los pacientes que pueden caminar.
    ? Evaluar el efecto de atalureno sobre la función de los músculos proximales en pacientes que pueden realizar pruebas cronometradas de la función.
    ? Evaluar el efecto de atalureno sobre la función física en pacientes que pueden realizar la evaluación deambulatoria North Star.
    ? Evaluar el efecto de atalureno sobre el funcionamiento de las extremidades superiores.
    Función pulmonar:
    ? Evaluar el efecto de atalureno sobre la función pulmonar.
    Resultados comunicados por el paciente:
    ? Determinar el efecto de atalureno sobre la calidad de vida relacionada con la salud (CdVRS) según lo comuniquen los pacientes y los progenitores/cuidadores.
    ? Evaluar el efecto de atalureno sobre las actividades cotidianas.
    Exposición:
    ? Evaluar la exposición plasmática de atalureno a largo plazo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completion of study treatment in the previous Phase 3, double-blind study protocol (Protocol PTC124-GD-020-DMD).
    2. 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.
    3. In subjects who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the study drug administration and 6-week follow-up period.
    4. Willingness and ability to comply with scheduled visits, ataluren administration plan, study procedures, laboratory tests, and study restrictions.
    1. Finalización del tratamiento del estudio en el protocolo del estudio anterior de fase III, doble ciego (Protocolo PTC124-GD 020 DMD).
    2. Constancia de los documentos de consentimiento/asentimiento informado firmados y fechados en los que se indique que se ha informado al paciente (o a sus progenitores/tutor legal) de todas las características pertinentes del ensayo clínico.
    3. En pacientes sexualmente activos, estar dispuestos a abstenerse de mantener relaciones sexuales o utilizar un anticonceptivo de barrera o médico durante la administración del fármaco del estudio y el período de seguimiento de seis semanas.
    4. Disposición y capacidad para cumplir el programa de visitas, el plan de administración de atalureno, los procedimientos del estudio, los análisis clínicos y las restricciones del estudio.
    E.4Principal exclusion criteria
    1. Known hypersensitivity to any of the ingredients or excipients of the study drug (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).
    2. Ongoing participation in any other therapeutic clinical trial.
    3. 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 patient, 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 principios o excipientes del fármaco del estudio (Litesse® UltraTM [polidextrosa refinada], polietilenglicol 3350, Lutrol® micro F127 [poloxámero 407], manitol 25C, crospovidona XL10, hidroxietilcelulosa, vainilla, Cab O Sil® M5P [sílice coloidal], estearato de magnesio).
    2. Participación actual en algún otro ensayo clínico terapéutico.
    3. Afección médica actual o anterior (por ejemplo, enfermedad concomitante, trastorno psiquiátrico, trastorno de la conducta, alcoholismo, drogadicción), antecedentes médicos, datos obtenidos en la exploración física o en los ECG, o alternaciones en los análisis que, a criterio del investigador, podrían afectar de forma negativa a la seguridad del paciente, hacer improbable que se finalice el ciclo de tratamiento o el seguimiento o que podrían afectar a 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 intensidad, el momento en que se produce y la relación de atalureno con cualquier acontecimiento adverso o alteración en los análisis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening visit, every 12 weeks up to 6 weeks post-treatment.
    Visita de selección, cada 12 semanas hasta 6 semanas postratamiento.
    E.5.2Secondary end point(s)
    Physical:
    1. Change in ambulation as measured by the 6MWT
    2. Change in proximal muscle function as assessed by timed function tests (time to rise from supine position, time to run 10 meters, and time to climb/descend 4 stairs)
    3. Change in physical function as assessed by the North Star Ambulatory Assessment
    4. Change in motor performance of the upper limb as measured by the Performance Upper Limb (PUL)
    Pulmonary function:
    5. Change in pulmonary function as measured by spirometry (eg. FVC, FEV1)
    Patient-reported outcomes:
    6. Change in patient- and parent/caregiver-reported HRQL as measured by the PODCI Transfer/Basic Mobility and Sports/Physical Functioning scores
    7. Change in patient and parent/caregiver reported activities of daily living
    Exposure:
    8. Pre-dose ataluren plasma concentrations prior to morning ataluren administration at each clinic visit as assessed by a validated bioanalytical method
    Safety:
    9. Change from baseline in other safety parameters (eg, vital signs)
    Físicos:
    1. Cambios en la deambulación según se determine en la prueba de deambulación de 6 minutos.
    2. Cambios en la función de los músculos proximales conforme se evalúe mediante las pruebas cronometradas de la función (tiempo para levantarse desde la posición de decúbito supino, tiempo para correr 10 metros y tiempo para subir/bajar 4 escalones)
    3. Cambios en la función física según se evalúe mediante la evaluación de la deambulación North Star
    4. Cambios en la actividad motora de las extremidades superiores según la medición de la evaluación de la actividad de las extremidades superiores (PUL por sus siglas en inglés)
    Función pulmonar:
    5. Cambios en la función pulmonar según se determine mediante la espirometría (por ejemplo, CVM y Vmáx)
    Resultados comunicados por el paciente:
    6. Cambios en la calidad de vida relacionada con la salud comunicada por el paciente y los progenitores/cuidador según se determine mediante las escalas de las partes de transferencia y movilidad básica y la actividad física/en deportes del instrumento de recopilación de datos de resultados pediátricos (PODCI)
    7. Cambios en las actividades cotidianas comunicadas por el paciente y los progenitores/cuidador
    Exposición:
    8. Las concentraciones plasmáticas de atalureno antes de la administración de atalureno por la mañana en cada visita al hospital valoradas mediante un método bioanalítico validado
    Seguridad:
    9. Cambios desde el momento inicial en otros parámetros de seguridad (por ejemplo, las constantes vitales).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3, 4, 6, 7, 8: Screening visit and every 12 weeks up to week 96
    5: Screening visit, at weeks 24, 48, 72 and 96
    9: Screening visit, every 12 weeks up to 6 weeks post-treatment
    1, 2, 3, 4, 6, 7, 8: Visita de selección y cada 12 semanas hasta semana 96
    5: Visita de selección, semanas 24, 48, 72 y 96
    9: Visita de selección, cada 12 semanas hasta 6 semanas postratamiento
    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 Yes
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 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 EEA23
    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
    Brazil
    Canada
    Chile
    Israel
    Korea, Republic of
    Switzerland
    Turkey
    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
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days23
    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: 220
    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: 110
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 110
    F.1.2Adults (18-64 years) No
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 220
    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)
    This study may be further extended by amendment until either ataluren becomes commercially available or the clinical development of ataluren in DMD is discontinued.
    Este estudio podría ampliarse mediante una enmienda, hasta que ataluren se comercialice o hasta que se termine el desarrollo clínico de ataluren en la DMD.
    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 Decision2014-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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