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    Summary
    EudraCT Number:2013-001514-15
    Sponsor's Protocol Code Number:101SK201
    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:2014-01-10
    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 number2013-001514-15
    A.3Full title of the trial
    A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) on Reducing Infarct Volume in Acute Ischemic Stroke
    Estudio multicéntrico, doble ciego, controlado por placebo, aleatorizado, de grupos paralelos, para evaluar la seguridad y la eficacia de natalizumab intravenoso (BG00002) para reducir el volumen del infarto en el accidente cerebrovascular isquémico agudo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study of the Safety and Efficacy of Natalizumab in Acute Ischemic Stroke
    Estudio Clinico de la Seguridad y eficacia de Natalizumab en accidente cerebrovascular isquémico agudo
    A.4.1Sponsor's protocol code number101SK201
    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 SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointnot available
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441628501000
    B.5.5Fax number441628501010
    B.5.6E-mailcta.submissions@biogenidec.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 Yes
    D.2.1.1.1Trade name TYSABRI
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAN100226, BG00002
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNATALIZUMAB
    D.3.9.1CAS number 189261-10-7
    D.3.9.4EV Substance CodeSUB22282
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Ischemic Stroke
    Accidente cerebrovascular isquémico agudo
    E.1.1.1Medical condition in easily understood language
    Acute Ischemic Stroke
    Accidente cerebrovascular isquémico agudo
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine whether one 300 mg dose of intravenous (IV) natalizumab reduces change in infarct volume from Baseline to Day 5 on magnetic resonance imaging (MRI) in subjects with acute ischemic stroke when given at ?6 hours or at >6 to ?9 hours from when they were last known normal (LKN).
    El objetivo principal del estudio consiste en determinar si una dosis de 300 mg por vía intravenosa (i.v.) de natalizumab reduce el cambio en el volumen del infarto desde el inicio hasta el día 5 en la resonancia magnética (RM) en pacientes con accidente cerebrovascular isquémico agudo cuando se administra a ? 6 horas o a entre > 6 y ? 9 horas desde el último momento conocido de normalidad (UMCN).
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study in this study population are as follows:
    ? To assess the efficacy of natalizumab on change in infarct volume from Baseline to Day 30
    ? To assess efficacy of natalizumab on change in infarct volume from 24 hours to Day 5 and Day 30
    ? To assess the efficacy of natalizumab on clinical measures of stroke outcome
    ? To assess the safety of natalizumab in subjects with acute ischemic stroke
    Los objetivos secundarios de este estudio en esta población de estudio son los siguientes:
    ?Evaluar la eficacia de natalizumab en el cambio en el volumen del infarto desde el inicio hasta el día 30
    ?Evaluar la eficacia de natalizumab en el cambio en el volumen del infarto desde las 24 horas hasta el día 5 y el día 30
    ?Evaluar la eficacia de natalizumab conforme a las medidas clínicas del resultado del accidente cerebrovascular
    ?Evaluar la seguridad de natalizumab en pacientes con accidente cerebrovascular isquémico agudo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The substudies to be performed in any of the involved countries are as
    follows:
    -Optional DNA analysis substudy: Optional DNA samples from whole blood may be collected for an exploratory pharmacogenomic analysis.
    Los subestudios a realizar en alguno de los paises involucrados son los siguientes:

    -Subestudio opcional de analisis de ADN: Se podrán recoger muestras ADN opcionales de sangre completa para realizar un análisis farmacogenómico exploratorio.
    E.3Principal inclusion criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria at Screening or at the timepoint specified in the individual eligibility criterion listed. All eligibility assessments must be completed in time for dosing within 6 hours or >6 to ?9 hours of the subject?s LKN:
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations OR provision of informed consent by the subject?s representative in accordance with all local and national regulations, and according to the local institutional review board?s (IRB?s)/ethics committee?s (EC?s) guidelines OR by another process compliant with applicable national laws and regulations and IRB/EC requirements.
    2. Aged 18 to 85 years old, inclusive, at the time of enrollment.
    3. Diagnosis of acute ischemic stroke defined by LKN at ?6 hours or at >6 to ?9 hours prior to study treatment initiation.
    4. Score of ?6 points on the NIHSS at Screening.
    5.At least 1 acute infarct with largest diameter of more than 2 cm on Baseline brain DWI
    6.Participants who have received reperfusion therapy (either tissue plasminogen activator or endovascular treatment) may be eligible to participate but must meet all eligibility criteria and perform the Baseline study MRI after reperfusion therapy has been completed.
    7.Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 3 months after their dose of study treatment.
    Para ser aptos para participar en este estudio, los candidatos deben cumplir los siguientes criterios de idoneidad en la selección o en el punto temporal especificado en el criterio de idoneidad individual indicado. Todas las evaluaciones de idoneidad se deben completar a tiempo para la administración de la dosis dentro de las 6 horas o entre > 6 y ? 9 horas desde el UMCN del paciente:
    1.Capacidad para comprender la finalidad y los riesgos del estudio y proporcionar un consentimiento informado firmado y fechado, así como una autorización para usar la información sanitaria protegida (PHI) de conformidad con las normativas nacionales y locales sobre la intimidad y privacidad de pacientes O la prestación del consentimiento informado por parte del representante del paciente, de conformidad con las normativas locales y nacionales, y de acuerdo con las directrices del comité ético de investigación clínica (CEIC)/comité de ética (CE) local O mediante otro proceso que cumpla con los reglamentos y leyes nacionales vigentes y los requisitos del CEIC/CE.
    2.Edad comprendida entre los 18 y 85 años, ambos inclusive, en el momento de la inclusión.
    3.Diagnóstico de accidente cerebrovascular isquémico agudo definido por el UMCN a ? 6 horas o entre > 6 y ? 9 horas antes del inicio del tratamiento del estudio.
    4.Puntuación ? 6 puntos en la escala NIHSS en el momento de la selección.
    5.Al menos 1 infarto agudo con el mayor diámetro de más de 2 cm en la DWI cerebral inicial.
    6.Los participantes que hayan recibido terapia de reperfusión (ya sea mediante activador del plasminógeno tisular o tratamiento endovascular) pueden ser aptos para participar, pero deben cumplir todos los criterios de idoneidad y realizar la RM inicial del estudio después de haber finalizado la terapia de reperfusión.
    7.Los pacientes con capacidad reproductiva deben utilizar medidas anticonceptivas eficaces durante el estudio, así como estar dispuestos y ser capaces de continuar con ellas durante al menos 3 meses después de su última dosis del tratamiento del estudio.
    E.4Principal exclusion criteria
    Candidates will be excluded from study entry if any of the following exclusion criteria exist at Screening or at the timepoint specified in the individual criterion listed:
    1. Presence of any ICH on head CT or non-petechial ICH on screening MRI.
    2. Stroke isolated to the brainstem.
    3. Presence of coma
    4. Expected to die OR unable to be evaluated within 5 days.
    5. Hypotension requiring the use of IV vasopressor support or systolic blood pressure <90 mmHg at the time of randomization.
    6. Known prior treatment with natalizumab.
    7. Immunocompromised subjects, as determined by the Investigator, based on medical history, physical examination, or laboratory testing, or due to prior or current cancer or immunosuppressive or immunomodulating treatment.
    8. History of PML.
    9. Contraindications to MRI, e.g., implanted pacemaker or other contraindicated implanted metal devices, history of or risk for side effects from gadolinium, or claustrophobia that cannot be medically managed.
    10. Abnormal laboratory values indicative of or history of significant medical, neurologic (other than stroke), or psychiatric disorders or known or suspected substance abuse that might, in the opinion of the Investigator, preclude safe participation in the study or confound study assessments.
    11. Known history of hematological malignancy within the last 5 years.
    12. Malignancy suspected to be the underlying cause of current stroke.
    13. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject?s ability to comply with the protocol.
    14. Nursing or pregnant female, female planning to become pregnant during study participation, or male planning to father a child during study participation.
    15. Known participation in any other investigational study that involved treatment with an investigational product within 6 months prior to enrollment.
    16. Recent or ongoing hypersensitivity reaction to tissue plasminogen activator treatment.
    17. Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment.
    Los candidatos serán excluidos del estudio si cumplen con alguno de los siguientes criterios de exclusión en el momento de la aleatorización o en el punto temporal especificado en el criterio individual indicado:
    1.Presencia de cualquier HIC en la TC de la cabeza o HIC no petequial en la RM de la selección.
    2.Accidente cerebrovascular aislado al tronco encefálico.
    3.Presencia de coma.
    4.Muerte prevista O incapacidad de evaluar al paciente dentro de los 5 días.
    5.Hipotensión que requiera el uso de vasopresores i.v. o presión arterial sistólica < 90 mmHg en el momento de la aleatorización.
    6.Tratamiento anterior conocido con natalizumab.
    7.Pacientes inmunodeprimidos, a criterio del investigador, en función de los antecedentes patológicos, la exploración física o las pruebas clínicas, o debido a un cáncer previo o actual o tratamiento inmunosupresor o inmunomodulador.
    8.Antecedentes de LMP.
    9.Pacientes en los que la RM está contraindicada, por ejemplo, que tienen un marcapasos u otros dispositivos metálicos implantados contraindicados, presenten antecedentes o riesgo de experimentar efectos secundarios del gadolinio o sufran claustrofobia que no puede tratarse médicamente.
    10.Valores clínicos anómalos indicativos de o antecedentes de trastornos médicos, neurológicos (excepto derrame cerebral) o psiquiátricos importantes, o toxicomanía conocida o sospechas de toxicomanía que podría, a criterio del investigador, impedir la participación segura en el estudio o perjudicar las evaluaciones del estudio.
    11.Antecedentes conocidos de neoplasia hematológica en los últimos 5 años.
    12.Sospecha de neoplasia que sea la causa subyacente del accidente cerebrovascular actual.
    13.Falta de disposición o incapacidad por parte del paciente de cumplir con los requisitos del protocolo, incluida la presencia de cualquier enfermedad (física, mental o social) que pueda afectar a la capacidad del paciente de cumplir con el protocolo del estudio.
    14.Mujer en periodo de lactancia o embarazada, mujer que esté planeando quedarse embarazada durante su participación en el estudio u hombre que esté planeando engendrar durante la participación en el estudio.
    15.Participación conocida en cualquier otro estudio de investigación donde hubo tratamiento con un producto experimental dentro de los 6 meses anteriores a la inscripción.
    16.Reacción de hipersensibilidad reciente o actual al tratamiento activador del plasminógeno tisular.
    17.Otra razón no especificada que, en opinión del investigador o de Biogen Idec, provoque que el paciente no sea apto para la inclusión.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in infarct volume from Baseline (diffusion-weighted imaging [DWI]) to Day 5 (fluid-attenuated inversion recovery [FLAIR])
    El criterio de valoración principal es el cambio en el volumen de infarto desde el inicio (imagen por difusión [DWI]) hasta el día 5 (recuperación de la inversión atenuada por líquido [FLAIR])
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 5
    Día 5
    E.5.2Secondary end point(s)
    The secondary endpoints are as follows:
    ? Change in infarct volume from Baseline (DWI) to Day 30 (FLAIR)
    ? Change in infarct volume from 24 hours (DWI) to Day 5 and Day 30 (FLAIR)
    ? Change in National Institute of Health Stroke Scale (NIHSS) score from Baseline to 24 hours, Day 5, Day 30, and Day 90
    ? Modified Rankin Scale (mRS) distribution at Day 5, Day 30, and Day 90
    ? Barthel Index at Day 5, Day 30, and Day 90
    ? Incidence of AEs and serious AEs (SAEs)
    Los criterios de valoración secundarios son los siguientes:
    ?Cambio en el volumen de infarto desde el inicio (DWI) hasta el día 30 (FLAIR)
    ?Cambio en el volumen de infarto desde las 24 horas (DWI) hasta el día 5 y el día 30 (FLAIR)
    ?Cambio en la puntuación en la escala de accidentes cerebrovasculares del National Institute of Health (NIHSS) desde el inicio hasta las 24 horas, el día 5, el día 30 y el día 90
    ?Distribución de la escala de Rankin modificada (mRS) el día 5, día 30 y día 90
    ?Índice de Barthel en el día 5, día 30 y día 90
    ?La incidencia de AA y acontecimientos adversos graves (AAG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? Infarct volume from Baseline: Day 30
    ? Infarct volume from 24 hours: Day 5 and Day 30
    ? NIHSS: 24 hours, Day 5, Day 30 and Day 90
    ? mRS: Day 5, Day 30, and Day 90
    ? Barthel Index: Day 5, Day 30, and Day 90
    ? SAEs: as necessary
    ? Volumen de infarto desde el inicio : Día 30
    ? Volumen de infarto desde las 24 horas: Día 5 y Día 30
    ? NIHSS: 24 horas, Día 5, Día 30 and Día 90
    ? mRS: Día 5, Día 30 and Día 90
    ? Índice de Barthel: Día 5, Día 30 and Día 90
    ? AAGs: cuando sea necesario
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Germany
    Spain
    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
    Última visita último paciente
    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 months10
    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 months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Provision of informed consent by subjects representative in accordance with local and national regulations and to local IRB/EC's guidelines OR by another process compliant with applicable national laws and regulations and IRB/EC requirements
    Suministro del consentimiento informado por personas representativas de acuerdo a las regulaciones locales y nacionales y a las guías de los CE u otros procesos compatibles con las leyes nacionales y los requisitos del CE
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 91
    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)
    No further provisions are made for access to the study treatment. If natalizumab is proven to be beneficial, all regulatory requirements regarding poststudy access will be met.
    No hay más disposiciones para el acceso al tratamiento del estudio. Si se comprueba que el natalizumab es beneficioso, se cumplirán todos los requisitos reglamentarios en materia de acceso a un post estudio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-09
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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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