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    Summary
    EudraCT Number:2018-003858-24
    Sponsor's Protocol Code Number:252BN201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 number2018-003858-24
    A.3Full title of the trial
    A Multicenter, Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients with Brain Contusion
    Estudio Fase 2, multicéntrico, doble ciego, multidosis, controlado con placebo, randomizado y de grupos paralelos para evaluar la eficacia y seguridad de BIIB093 intravenoso en pacientes con contusión cerebral
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants with Brain Contusion
    Estudio para evaluar la eficacia y la seguridad de BIIB093 en sujetos participantes con contusión cerebral
    A.4.1Sponsor's protocol code number252BN201
    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
    B.5.2Functional name of contact pointMedical Director/Monitor
    B.5.3 Address:
    B.5.3.1Street AddressInnovation house, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+3491 3707110
    B.5.5Fax number+3491 3707181
    B.5.6E-mailClinicialTrials@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 No
    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 nameBIIB093(Glibenclamide)
    D.3.2Product code BIIB093
    D.3.4Pharmaceutical form Powder for concentrate and solution 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 INNBIIB093 (Glibenclamide)
    D.3.9.1CAS number 10238-21-8
    D.3.9.2Current sponsor codeBIIB093
    D.3.9.3Other descriptive nameGlyburide
    D.3.9.4EV Substance CodeSUB07916MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for concentrate 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
    Brain contusion
    Contusión cerebral
    E.1.1.1Medical condition in easily understood language
    Brain contusion
    Contusión cerebral
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10052346
    E.1.2Term Brain contusion
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo.
    El objetivo principal del estudio es determinar si BIIB093 reduce la expansión de la contusión cerebral al llegar a la Hora 96 en comparación con un placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on
    hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.
    Los objetivos secundarios son evaluar los efectos de BIIB093 en el estado neurológico agudo, los resultados funcionales y los requisitos del tratamiento para diferenciar aún más el mecanismo de acción de BIIB093 sobre la expansión de la contusión examinando los efectos diferenciales en la expansión del hematoma y el edema y para determinar si BIIB093 mejora la supervivencia en el día 90 en comparación con el placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    • Clinical diagnosis of brain contusion with lesions within the supratentorial brain parenchyma totaling > 3 mL in volume per Investigator assessment of baseline non contrast computed tomography scan (NCCT) at Screening.
    • A score of 5 to 14 on the Glasgow Coma Scale (GCS)
    • Functionally independent, in the opinion of the Investigator, prior to index head injury.
    • Diagnóstico clínico de contusión cerebral con lesiones en el parénquima supratentorial cerebral con un volumen >3 ml según una evaluación efectuada por el Investigador de una exploración inicial por tomografía computarizada sin contraste (TCSC) en la Selección.
    • Una puntuación de 5 a 14 en la Escala de Coma de Glasgow (GCS)
    • Funcionalidad independiente, en opinión del investigador, antes del traumatismo craneal de referencia.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    • In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.
    • Clinical signs of brainstem herniation, in the opinion of the Investigator.
    • NCCT or magnetic resonance imaging (MRI) evidence of penetrating brain injury.
    • Any presence of midbrain or posterior fossa injury as assessed by imaging and clinical examination.
    • Presence of concomitant spinal cord injury as assessed by imaging and clinical examination.
    • Polytrauma (intra-abdominal or orthopedic trauma) requiring operative/surgical management, if known.
    Minor fractures requiring splinting or reduction of dislocations is permitted, as are nonoperative intraabdominal injuries.
    •Use of novel oral anticoagulants (NOACS; including direct thrombin inhibitors such as dabigatran, or Factor Xa inhibitors such as rivaroxaban or apixaban), in preceding 3 days prior to the injury, if known.
    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
    • A criterio del investigador, es probable al participante se le retiren el tratamiento de soporte en el plazo de 24 horas.
    • Signos clínicos de hernia del tronco encefálico, en opinión del investigador.
    • Indicios de lesión cerebral penetrante en la TCSC o la resonancia magnética (RM).
    • Cualquier presencia de lesión del mesencéfalo o de la fosa craneal posterior según la exploración por imágenes y el examen clínico.
    • Presencia de lesión concomitante de la médula espinal según la exploración por imágenes y el examen clínico.
    • Politraumatismo (traumatismo intraabdominal u ortopédico) que requiera tratamiento quirúrgico, si se conoce.
    Se permiten las fracturas menores que requieran ferulización o reducción de luxaciones, ya que se trata de lesiones intraabdominales no quirúrgicas.
    • Uso de nuevos anticoagulantes orales (NACO; incluidos los inhibidores directos de la trombina como el dabigatrán, o inhibidores del factor Xa como rivaroxabán o apixabán), en los 3 días anteriores a la lesión, si se conoce.
    NOTA: Podrán aplicarse otros criterios de exclusión/inclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of Participants With Contusion Expansion.

    Participants with contusion expansion will be determined by comparison of the baseline images and the 96-hour scan or the scan obtained prior to any neurosurgical intervention (NSx) or comfort measures only (CMO). NSx includes craniotomy and decompressive
    craniectomy (DC).
    Proporción de participantes con expansión de la contusión.

    Los participantes con expansión de la contusión se determinarán en base a una comparación de las imágenes iniciales con la exploración realizada a las 96 horas o la obtenida antes de cualquier intervención neuroquirúrgica (iNQ) o de instaurar solo medidas paliativas (SMP).Las iNQ incluyen la craneotomía y la craniectomía descompresiva (CD).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 96 hours of start of study treatment infusion
    En el plazo de 96 horas desde el inicio de la infusión del tratamiento del estudio
    E.5.2Secondary end point(s)
    - Proportion of Participants With Improvement in Glasgow Outcome Scale – Extended (GOS-E).
    - Proportion of Participants With Improvement in Modified Rankin Scale (mRS).
    - Proportion of Participants Requiring Delayed Intubation
    - Change from Baseline in Absolute Hematoma Volume at Hour 24
    - Change from Baseline in Absolute Edema Volume at Hour 96
    - Time to All-cause Death
    - Proporción de participantes con mejora en la Escala de resultados de Glasgow ampliada (GOS-E).
    - Proporción de participantes con mejora en la Escala de Rankin modificada (mRS).
    - Proporción de participantes que requieran intubación diferida.
    - Cambio en el volumen absoluto del hematoma desde el inicio hasta las 24 horas.
    - Cambio en el volumen absoluto del edema desde el inicio hasta las 96 horas.
    - Tiempo hasta la muerte por cualquier causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - GOS-E: Day 90
    - mRS: Day 90
    - Delayed Intubation: Day 1 (Hour 24) to Day 4 (Hour 96)
    - Absolute Hematoma: Baseline up to Day 1 (Hour 24)
    - Absolute Edema Volume: Baseline up to Day 4 (Hour 96)
    - All-cause Death: Baseline up to Day 90
    - GOS-E: Día 90
    - mRS: Día 90
    - Intubación diferida: Día 1 (24 horas) al día 4 (96 horas)
    - Volumen absoluto del hematoma: Inicio hasta el día 1 (24 horas)
    - Volumen absoluto del edema: Inicio hasta el día 4 (96 horas)
    - Muerte por cualquier causa: Inicio hasta 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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 trial4
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    France
    Germany
    Israel
    Italy
    Japan
    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
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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
    A sub group patients may not be able to provide consent due to being
    incapacitated as a result of the brain contusion following a brain trauma and this is most likely to be in an emergency setting.
    Un subgrupo de pacientes podría no ser capaz de proporcionar el consentimiento debido a su incapacidad como resultado de la contusión cerebral tras un traumatismo cerebral y es muy probable que se encuentren en el servicio de urgencias.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 160
    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)
    There is no provision to provide study treatment after the study.
    No hay ninguna disposición para proporcionar tratamiento de estudio después del 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 Decision2019-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-30
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