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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7264   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2009-012037-30
    Sponsor's Protocol Code Number:SNT-III-003
    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:2012-03-29
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2009-012037-30
    A.3Full title of the trial
    A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 ? 18 Year Old Patients with Duchenne Muscular Dystrophy
    Estudio de fase III, a doble ciego, aleatorizado y controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de la idebenona en pacientes de 10 a 18 años con distrofia muscular de Duchenne
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hereditary neuromuscular disease
    Enfermedad neuromuscular hereditaria
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberSNT-III-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01027884
    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 SponsorSanthera Pharmaceuticals (Switzerland) Limited
    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 supportSanthera
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Leuven-Children Hospital
    B.5.2Functional name of contact pointDr. Gunnar Buyse
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post codeB-3000
    B.5.4Telephone number+3216343843
    B.5.5Fax number+3216343842
    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/3/07/437
    D.3 Description of the IMP
    D.3.1Product nameIdebenone
    D.3.2Product code SNT-MC17
    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 INNIDEBENONE
    D.3.9.1CAS number 58186279
    D.3.9.2Current sponsor codeSNT-MC17
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboTablet
    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
    Duchenne Muscular Dystrophy
    Distrofia muscular de Duchenne
    E.1.1.1Medical condition in easily understood language
    Hereditary neuromuscular disease
    Enfermedad neuromuscular hereditaria
    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 10013801
    E.1.2Term Duchenne 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 efficacy of idebenone, compared to placebo, in improving respiratory function or delaying the loss of respiratory function in patients with DMD.
    Evaluar la eficacia de idebenona, en comparación con placebo, en la mejoría de la función respiratoria o el retraso de la pérdida de la función respiratoria en pacientes con DMD.
    E.2.2Secondary objectives of the trial
    ?To assess the efficacy of idebenone, compared to placebo, in improving respiratory function or delaying the loss of respiratory function using measures other than those used for the primary endpoint
    ?To assess the efficacy of idebenone, compared to placebo, in improving skeletal muscle strength/motor function or delaying the loss of skeletal muscle strength/motor function
    ?To assess the efficacy of idebenone, compared to placebo, in improving quality of life or delaying the loss in quality of life
    ?To assess the safety and tolerability of idebenone in patients with DMD
    ? Evaluar la eficacia de idebenona, en comparación con placebo, en la mejoría de la función respiratoria o el retraso de la pérdida de la función respiratoria utilizando determinaciones distintas a las utilizadas para la variable principal
    ? Evaluar la eficacia de idebenona, en comparación con placebo, en la mejoría de la fuerza del músculo esquelético / función motora o el retraso de la pérdida de la fuerza del músculo esquelético / función motora
    ? Evaluar la eficacia de idebenona, en comparación con placebo, en la mejoría de la calidad de vida o el retraso de la pérdida de la calidad de vida
    ? Evaluar la seguridad y la tolerabilidad de idebenona en pacientes con DMD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients 10 ? 18 years of age at Baseline.
    2.Signed and dated informed consent.
    3.Documented diagnosis of DMD or severe dystrophinopathy and clinical features consistent of typical DMD at diagnosis (i.e. documented delayed motor skills and muscle weakness by age 5 years). DMD should be confirmed by mutation analysis in the dystrophin gene or by substantially reduced levels of dystrophin protein (i.e. absent or <5% of normal) on Western blot or immunostain.
    4.Ability to provide reliable and reproducible repeat PEF within 15% of the first assessment (i.e. Baseline vs. Screening).
    5.Patients assessed by the investigator as willing and able to comply with the requirements of the study, possess the required cognitive abilities and are able to swallow study medication.
    1. Pacientes de 10 ? 18 años de edad en el momento basal.
    2. Consentimiento informado firmado y fechado.
    3. Diagnóstico documentado de DMD o distrofinopatía severa y
    características clínicas compatibles con DMD típica al diagnóstico (o sea, retraso documentado de las habilidades motoras y debilidad muscular antes de los 5 años de edad). La DMD deberá confirmarse mediante análisis de mutaciones en el gen de la distrofina o mediante la reducción sustancial de los niveles de la proteína distrofina (o sea, ausente o <5% de lo normal) con Western blot o munotinción.
    4. Capacidad para proporcionar FEM repetidos reproducibles y fiables dentro del 15% de la primera evaluación (o sea, Basal frente a Selección).
    5. El Investigador piensa que los pacientes están dispuestos y son capaces de cumplir con los requisitos del estudio, poseen la capacidad cognitiva necesaria y son capaces de tragar la medicación del estudio.
    E.4Principal exclusion criteria
    1.Patients dependent on assisted ventilation at Screening and/or Baseline (defined as non-invasive nocturnal ventilation, daytime non-invasive ventilation or continuous invasive ventilation).
    2.Patients with documented DMD-related hypoventilation for which assisted ventilation is needed according to current standard of care guidelines (e.g. FVC< 30%) or is required in the opinion of the Investigator.
    3.Patients with a percent predicted PEF > 80% at Baseline.
    4.Patients unable to form a mouth seal to allow precise respiratory flow measurements and mouth pressures.
    5.Symptomatic heart failure (high probability of death within one year of Baseline) and/or symptomatic ventricular arrhythmias.
    6.Participation in the previous Phase II or Phase II Extension study (SNT-II-001 or SNT-II-001-E) for idebenone.
    7.Participation in any other therapeutic trial and/or intake of any investigational drug within 90 days prior to Baseline.
    8.Use of carnitine, creatine, glutamine, oxatomide, or any herbal medicines (unless written evidence (e.g from the manufacturer or a physician) that the herbal medicine does not contain steroids is provided) within 30 days prior to Baseline.
    9.Use of coenzyme Q10 or vitamin E (if taken at a dose of 5 times above the daily physiological requirement) within 30 days prior to Baseline.
    10.Any previous use of idebenone.
    11.Any concomitant medication with a depressive or stimulating effect on respiration or the respiratory tract.
    12.Planned or expected spinal fixation surgery during the study period (as judged by the investigator).
    13.Asthma, bronchitis/COPD, bronchiectasis, emphysema, pneumonia or the presence of any other non-DMD respiratory illness that affects PEF.
    14.Chronic* use of ?-agonists or the use of any other bronchodilating medication (i.e. inhaled steroids, sympatomimetics, anti-cholinergics).
    15.Moderate or severe hepatic impairment or severe renal impairment.
    16.Prior or ongoing medical condition or laboratory abnormality that in the Investigator?s opinion could adversely affect the safety of the subject
    17.Relevant history of or current drug or alcohol abuse or use of any tobacco/marijuana products/smoking
    18.Known individual hypersensitivity to idebenone or to any of the ingredients/excipients of the study medication
    19. For ?glucocorticoid non-users? only
    a)Chronic use of systemic glucocorticoid therapy for DMD related conditions within 12 months of Baseline (the ?12 month non-use period?)
    b)More than 2 rounds of acute systemic glucocorticoid burst therapy (of ?2 week duration) for non-DMD related conditions within the 12 month non-use period
    c)Use of any round of systemic glucocorticoid burst therapy of longer than 2 weeks duration within the 12 month non-use period
    d)Use of systemic glucocorticoid burst therapy less than 8 weeks prior to baseline
    20. For ?glucocorticoid users? only
    a)Prior to Interim Analysis 1: All glucocorticoid users
    b)After the Interim Analysis 1: Initiation, cessation or any relevant change (i.e. dose change of >15% above any dose adaptation for body weight increase/decrease) in systemic glucocorticoid therapy within 6 months prior to Baseline.
    *Chronic use is defined as a daily intake for more than 14 days.
    1. Pacientes dependientes de ventilación asistida en la Selección y/o en el momento basal (definida como ventilación nocturna no invasiva, ventilación diurna no invasiva o ventilación invasiva continua).
    2. Pacientes con hipoventilación relacionada con la DMD documentada que necesitan ventilación asistida de acuerdo con las directrices de la práctica estándar actual (p. ej., CVF< 30%) o según la opinión del Investigador.
    3. Pacientes con un FEP predicho porcentual >80% en el momento basal.
    4. Pacientes incapaces de crear un sellado bucal para permitir
    determinaciones precisas de los flujos respiratorios y las presiones bucales.
    5. Insuficiencia cardiaca sintomática (probabilidad elevada de muerte en el año siguiente al momento basal) y/o arritmias ventriculares sintomáticas.
    6. Participación en el estudio previo de fase II o en el estudio previo de extensión de fase II (SNT-II-001 o SNT-II-001-E) con idebenona.
    7. Participación en cualquier otro ensayo terapéutico y/o toma de cualquier fármaco en investigación en los 90 días anteriores al momento basal.
    8. Uso de carnitina, creatina, glutamina, oxatomida o cualquier otra hierba medicinal (a no ser que se proporcione evidencia por escrito (p. ej., del fabricante o de un médico) de que la hierba medicinal no contiene esteroides) en los 30 días anteriores al momento basal.
    9. Uso del coenzima Q10 o de vitamina E (tomada a una dosis 5 veces superior a la necesidad fisiológica diaria) en los 30 días anteriores al momento basal.
    10. Utilización previa de idebenona.
    11. Cualquier medicación concomitante con efecto depresor o estimulante sobre la respiración o el tracto respiratorio.
    12. Cirugía fijadora de la columna prevista o esperada durante el periodo del estudio (según el criterio del investigador).
    13. Asma, bronquitis/EPOC, bronquiectasias, enfisema, neumonía o presencia de otras enfermedades respiratorias no relacionadas con la DMD que afecten al FEM.
    14. Uso crónico* de agonistas beta-2 o cualquier uso de otras medicaciones broncodilatadoras (p. ej., esteroides inhalados, simpaticomiméticos, anticolinérgicos).
    15. Deterioro hepático moderado o severo o deterioro renal severo.
    16. Trastornos médicos o alteraciones analíticas previas o actuales que según la opinión del investigador podrían afectar de forma negativa a la seguridad del paciente2.
    17. Antecedentes relevantes o presencia en la actualidad de abuso de alcohol o de drogas, o uso de cualquier producto derivado del tabaco o la marihuana/fumado.
    18. Hipersensibilidad individual conocida a idebenona o a cualquiera de los componentes o excipientes de la medicación del estudio.
    19. Sólo en ?pacientes que no utilizan glucocorticoides?
    a) Utilización crónica de tratamiento con glucocorticoides sistémicos para trastornos relacionados con la DMD en los 12 meses anteriores al momento basal (el ?periodo de no utilización de 12 meses?)
    b) Más de 2 ciclos de tratamiento de choque con glucocorticoides
    sistémicos agudos (de ?2 semanas de duración) para trastornos no relacionados con la DMD en el periodo de no utilización de 12 meses
    c) Utilización de algún ciclo de tratamiento de choque con
    glucocorticoides sistémicos de más de 2 semanas de duración en el periodo de no utilización de 12 meses
    d) Utilización de tratamiento de choque con glucocorticoides sistémicos menos de 8 semanas antes del momento basal
    20. Sólo en ?pacientes que utilizan glucocorticoides?
    a) Antes del 1er análisis intermedio: todos los ?pacientes que utilizan glucocorticoides?
    b) Después del 1er análisis intermedio: inicio, cese o cualquier cambio relevante (o sea, cambio de la dosis de >15% por encima de cualquier adaptación de la dosis debida a aumento/disminución del peso corporal) en el tratamiento con glucocorticoides sistémicos en los 6 meses anteriores al momento basal.
    *El uso crónico se define como la toma diaria durante más de 14 días.
    E.5 End points
    E.5.1Primary end point(s)
    The change from Baseline to Week 52 in percent predicted Peak Expiratory Flow (PEF)
    Cambio desde el momento basal hasta la Semana 52 en el flujo espiratorio máximo (FEM) predicho porcentual
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52 after study start
    Semana 52 después del inicio del estudio
    E.5.2Secondary end point(s)
    In pulmonary function:
    -The change from Baseline to Week 52 in percent predicted Forced Vital Capacity (FVC), Peak Cough Flow (PCF), Maximal Expiratory Pressure (MEP) and Maximal Inspiratory Pressure (MIP)
    -Number of patients in each treatment that begin assisted ventilation during the study period
    In motor function:
    -The change from Baseline to Week 52 in muscle strenght as measured by hand-held myometry (HHM) and in motor function as assessed using the Brooke and Vignos scales
    In quality of life:
    -The change from Baseline to Week 52 in quality of life assessed by the PedsQL Quality of Life Inventory and Multidimensional Fatigue Scale
    -Differences in the Clinical Global Impression of efficacy and tolerability at Week 52 between two study arm
    -Differences between patient responses to the "satisfaction with treatment" question at Week 52 between two study arms
    -Number of patients in each study arm that during the study period require: acute hospitalization for treatment of a respiratory or other complication associated with disease progression, the initiation of the use of a brace or spinal jacket, initiation or change in systematic glucocorticoid treatment or need for assisted vantilation
    Measures of safety and tolerability of idebenone
    ? Función pulmonar:
    o Cambio desde el momento basal hasta la Semana 52 en la capacidad vital forzada (CVF) predicha porcentual, el flujo tusígeno máximo (FTM) predicho porcentual, la presión espiratoria máxima (PEM) predicha porcentual, la presión inspiratoria máxima (PIM) predicha porcentual
    o Número de pacientes de cada brazo de tratamiento que comienzan con ventilación asistida durante el periodo del estudio (debido a desarrollo documentado de hipoventilación relacionada con la DMD)
    ? Fuerza muscular / función motora:
    o Cambio desde el momento basal hasta la Semana 52 en la fuerza muscular medida mediante miometría manual (MM, la función motora evaluada mediante las escalas de Brooke y Vignos
    ? Calidad de vida:
    o Cambio desde el momento basal hasta la Semana 52 en la calidad de vida evaluada mediante el Inventario de Calidad de Vida PedsQL? (formularios referidos por los niños y los adolescentes)
    o Cambio desde el momento basal hasta la Semana 52 en la Escala Multidimensional de Fatiga PedsQL? (formularios referidos por los niños y los adolescentes)
    o Diferencias en la Impresión Clínica Global de eficacia y tolerabilidad en la Semana 52 entre los dos brazos del estudio
    o Diferencias entre las respuestas de los pacientes a la pregunta de ?satisfacción con el tratamiento? en la Semana 52 entre los dos brazos del estudio
    o Número de pacientes en cada brazo del estudio que durante el periodo del estudio precisan: hospitalización aguda para el tratamiento de una complicación respiratoria o de otro tipo asociadas a la progresión de la enfermedad, inicio de la utilización de aparatos ortopédicos o corsés, inicio o cambio en el tratamiento con glucocorticoides sistémicos, necesidad de ventilación asistida.
    ? Medidas de la seguridad y la tolerabilidad de idebenona.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52 after study start
    Semana 52 después del inicio del estudio
    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. 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 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 Yes
    E. trial design description
    Group Sequential Design
    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 trial2
    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 EEA12
    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
    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
    The end of the DELOS trial is defined as the Last Patient Last Visit date. Last Patient Last Visit is either the date of the last patient visit of the last patient to complete the study, or the date at which the last data point from the last patient, which was required for statistical analysis (i.e. key safety and efficacy results for decision making), was received, whichever is the later date.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 Yes
    F.1.1Number of subjects for this age range: 280
    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. of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 200
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    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 Yes
    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 Yes
    F. of subjects incapable of giving consent
    Children and adolescent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 280
    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)
    All patients completing Visit 6/Week 52, and considered eligible by the investigator will be able to participate in an open-label extension study or compassionate use program pending approval by the respective Regulatory Authority and Ethics Committee. For patients not continuing into the extension study, a Follow-up Visit will take place 4 weeks after discontinuation of study medication (Visit 7/Week 56).
    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 Decision2012-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-14
    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
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