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    Summary
    EudraCT Number:2015-004783-11
    Sponsor's Protocol Code Number:101SK202
    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:2016-02-17
    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 number2015-004783-11
    A.3Full title of the trial
    A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) in Acute Ischemic Stroke
    Estudio de búsqueda de dosis, multicéntrico, doble ciego, controlado con placebo, aleatorizado y de grupos paralelos, para evaluar la seguridad y la eficacia de natalizumab intravenoso (BG00002) 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
    Un ensayo clínico de la seguridad y eficacia de Natalizumab en el accidente cerebrovascular isquémico agudo
    A.4.1Sponsor's protocol code number101SK202
    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 applicable
    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 number+3491702 7963
    B.5.5Fax number+3491310 7110
    B.5.6E-mailclinicaltrials@biogen.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 18.1
    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 assess the effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of independence and activities of daily life
    El objetivo principal del estudio es evaluar los efectos de natalizumab frente a placebo en el accidente cerebrovascular isquémico agudo, en cuanto a las medidas clínicas de independencia y actividades de la vida diaria.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to explore dose and exposure response and the clinical treatment effects of natalizumab versus placebo in acute ischemic stroke on the following measures of independence, activities of daily living, neurologic function, quality of life, and cognition and safety and tolerability.
    El objetivo secundario del estudio es investigar la respuesta a la dosis y a la exposición, así como los efectos clínicos del tratamiento de natalizumab frente a placebo en el accidente cerebrovascular isquémico agudo en cuanto a las siguientes medidas de independencia, actividades de la vida diaria, función neurológica, calidad de vida y cognición, seguridad y tolerabilidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ?9 hours prior to study treatment initiation
    - Score of 5 to 23 points, inclusive, on the NIHSS at Screening
    - Prior to index stroke, patient was able to perform basic activities of daily living without assistance
    - For those subjects who underwent a cranial MRI, there is at least 1 acute infarct with a diameter of ?2 cm on baseline brain diffusion-weighted imaging
    NOTE: Other protocol-defined inclusion criteria may apply.
    -Diagnóstico clínico de accidente cerebrovascular isquémico agudo supratentorial definido por el UMCN a ?9 horas antes del inicio del tratamiento del estudio.
    -Puntuación de 5 a 23 puntos, ambos inclusive, en la NIHSS en el momento de la selección.
    -Antes del accidente cerebrovascular de referencia, el paciente era capaz de realizar las actividades básicas de la vida diaria sin ayuda.
    -En los sujetos sometidos a una RM craneal, hay al menos 1 infarto agudo con un diámetro de ?2 cm en las imágenes cerebrales ponderadas por difusión iniciales.
    NOTA: Otros criterios definidos en el protocolo pueden aplicar.
    E.4Principal exclusion criteria
    - Rapidly improving or minor stroke symptoms
    - Lacunar or isolated brainstem stroke based on clinical assessment and available acute imaging studies
    - Presence of acute intracranial hemorrhage on acute brain CT or MRI
    - Severe stroke
    NOTE: Other protocol-defined exclusion criteria may apply.
    -Síntomas de accidente cerebrovascular menores o que mejoran rápidamente.
    -Accidente cerebrovascular del tronco encefálico lacunar o aislado según la evaluación clínica y los estudios por imagen del momento agudo disponibles
    -Presencia de hemorragia intracraneal aguda en la TAC o la RM cerebral aguda
    -Accidente cerebrovascular grave
    NOTA:
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is a composite global measure of functional disability based on a score of 0 or 1 on the mRS and a score of ?95 on the BI at Day 90
    El criterio de valoración de eficacia principal es una medida global compuesta de la discapacidad funcional, basada en una puntuación de 0 o 1 en la escala de Rankin modificada (mRS) y una puntuación ?95 en el Índice de Barthel (IB) el día 90
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 90
    Día 90
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    - mRS score at Day 90
    - BI score at Day 90
    - SIS-16 score at Day 90
    - MoCA score at Day 90
    - Safety (incidence and proportion of AEs and SAEs)
    - NIHSS score at Day 90
    Los criterios de valoración secundarios son:
    -Puntuación de la mRS el día 90
    -Puntuación del IB el día 90
    -Puntuación de la Escala de impacto del accidente cerebrovascular 16 el día 90
    -Puntuación de la Evaluación cognitiva de Montreal el día 90
    -Seguridad (incidencia y porcentajes de acontecimientos adversos y acontecimientos adversos graves)
    -Puntuación de la Escala de accidentes cerebrovasculares del National Institute of Health (National Institute of Health Stroke Scale, NIHSS) el día 90
    E.5.2.1Timepoint(s) of evaluation of this end point
    - mRS score: Day 90
    - BI score: Day 90
    - SIS-16 score: Day 90
    - MoCA score: Day 90
    - AEs and SAEs: throughout the study, as necessary
    - NIHSS score at Day 90
    -Puntuación de la mRS el día 90
    - Puntuación del IB el día 90
    - Puntuación de la Escala de impacto del accidente cerebrovascular 16 el día 90
    - Puntuación de la Evaluación cognitiva de Montreal el día 90
    - Seguridad (incidencia y porcentajes de acontecimientos adversos y acontecimientos adversos graves)
    - Puntuación de la Escala de accidentes cerebrovasculares del National Institute of Health (National Institute of Health Stroke Scale, NIHSS) el día 90
    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 Yes
    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 trial3
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    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 months3
    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: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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
    Prestación del CI por el representante de los sujetos, de acuerdo con regulaciones locales y nacionales y directrices locales de la CE o por otro proceso que cumple con las leyes y reglamentos nacionales aplicables y los requisitos del EC
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 240
    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.
    Tras la finalización del ensayo no esta previsto proveer el acceso al tratamiento del estudio. Si natalizumab ha demostrado ser beneficioso, se cumplirán todos los requisitos reglamentarios en materia de acceso estudio post.
    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 Decision2016-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-20
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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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