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    Summary
    EudraCT Number:2017-004854-41
    Sponsor's Protocol Code Number:252LH301
    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:2018-07-17
    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 number2017-004854-41
    A.3Full title of the trial
    Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction
    Estudio en fase III, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y la seguridad de BIIB093 por vía intravenosa (glibenclamida) para el edema cerebral grave tras infarto hemisférico maligno
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the use of the investigational drug BIIB093 versus placebo in patients with a large hemispheric infarction.
    Estudio para evaluar el uso del fármaco en investigación BIIB093 versus placebo en pacientes con grave infarto hemisférico
    A.3.2Name or abbreviated title of the trial where available
    CHARM
    CHARM
    A.4.1Sponsor's protocol code number252LH301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02864953
    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 Reseach 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 Ltd.
    B.5.2Functional name of contact pointBiogen España
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 41
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number0034913707110
    B.5.5Fax number0034913707181
    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 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 INNGLIBENCLAMIDE
    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
    Cerebral edema following Large Hemispheric Infarction
    Edema cerebral grave tras infarto hemisférico maligno
    E.1.1.1Medical condition in easily understood language
    Brain swelling after stroke
    Inflamación cerebral después del accidente cerebrovascular
    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 LLT
    E.1.2Classification code 10008107
    E.1.2Term Cerebral edema
    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 is to determine if BIIB093 improves functional outcome at Day 90 as measured by the modified Rankin Scale (mRS) when compared with placebo in participants with Large Hemispheric Infarction (LHI).
    El objetivo principal es determinar si BIIB093 mejora el resultado funcional en el día 90 según la medición de la Escala Rankin modificada (modified Rankin Scale, mRS) al compararlo con placebo en sujetos con IHM.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to determine if BIIB093 improves overall survival at Day 90 when compared with placebo, if BIIB093 improves functional outcome at Day 90 on the mRS dichotomized 0-4 vs. 5-6 when compared with placebo, if BIIB093 reduces midline shift at 72 hours (or at time of decompressive craniectomy [DC] or comfort measures only [CMO], if earlier) when compared with placebo, and to evaluate the safety and tolerability of BIIB093 in participants with LHI.
    Los objetivos secundarios son determinar mejora la supervivencia general el día 90 en comparación con placebo,s i BIIB093 mejora el resultado funcional el día 90 en la mRS dicotomizada 0-4 frente a 5-6, en comparación con placebo, si BIIB093 reduce el cambio en la línea media a las 72 horas (o en el momento de la craneotomía descompresiva o de solo medidas paliativas, si se producen antes) en comparación con placebo y • Evaluar la seguridad y la tolerabilidad de BIIB093 en sujetos con IHM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory
    2.A large hemispheric infarction defined as; lesion volume of 80 to 300 centimeters cubed (cm^3) on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP), or an Alberta Stroke Program Early CT Score (ASPECTS) of 1 to 5 with involvement of at least 2 defined cortical regions
    3. Screening National Institutes of Health Stroke Scale (NIHSS) >=10
    4. Study treatment infusion within 10 hours after time of symptom onset, if known, or the time last known normal
    5. For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI

    NOTE: Other protocol defined Inclusion criteria may apply
    1. Diagnóstico clínico de accidente cerebrovascular isquémico agudo en el territorio de MCA.
    2. Un infarto hemisférico maligno se define como: volumen de la lesión según resonancia magnética (RM) mediante imagen ponderada por difusión (IPD) de 80 a 300 cm3, o volumen de la lesión según perfusión por tomografía computarizada (PTC) de 80 a 300 cm3, o una puntuación de 1 a 5 del Programa de accidentes cerebrovasculares de Alberta (Alberta Stroke Program Early computed tomography Score, ASPECTS) con afectación de al menos 2 regiones corticales definidas.
    3. NIHSS en la selección ≥10.
    4. La infusión del tratamiento del fármaco del estudio se debe iniciar antes de que transcurran 10 horas desde el momento de la aparición de los síntomas, si se sabe, o el último momento conocido de normalidad.
    5. Para los sujetos que reciben trombectomía, la inclusión en el estudio debe basarse en RM IPD posterior a la trombectomía.

    Nota: Existen otros criterios de inclusión definidos por protocolo.
    E.4Principal exclusion criteria
    1.Participant is likely to have supportive care withdrawn on the first day
    2.Commitment to decompressive craniectomy (DC) prior to enrollment
    3.Evidence of concurrent infarction in the contralateral hemisphere sufficiently serious so as to affect functional outcome

    NOTE: Other protocol defined Exclusion criteria may apply
    1. El sujeto es probable que se retire el tratamiento de apoyo el primer día.
    2. Compromiso de craneotomía descompresiva (CD) antes de la inscripción.
    3. Indicios de infarto concurrente en el hemisferio contralateral lo suficientemente grave como para afectar a los resultados funcionales.

    Nota: Existen otros criterios de exclusión definidos por protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS)
    Proporción de sujetos con mejoría en el resultado funcional en el día 90 evaluada según la medición de la Escala Rankin modificada (modified Rankin Scale, mRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline up to Day 90
    Línea media hasta el día 90
    E.5.2Secondary end point(s)
    1.Time to All-Cause Death [ Time Frame: Baseline up to Day 90 ]
    2.Proportion of Participants who achieved mRS 0-4 at Day 90 [Time Frame: Baseline up to Day 90]
    3.Reduction in Midline Shift at 72 Hours [ Time Frame: Baseline up to 72 Hours]
    4.Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 90]
    1. Tiempo transcurrido hasta la muerte por cualquier causa (desde Visita Basal hasta el día 90).
    2. Proporción de sujetos que lograron una mRS de 0-4 el día 90 (desde Visita Basal hasta el día 90).
    3. Cambio en la línea media a las 72 horas (desde Visita Basal hasta las 72 horas).
    4. La incidencia de acontecimientos adversos, acontecimientos adversos graves (AAG) (desde Visita Basal hasta el día 90).
    E.5.2.1Timepoint(s) of evaluation of this end point
    #’s 1, 2 & 4 (Baseline up to Day 90)
    #3 (Baseline up to 72 hours)
    # 's 1, 2 y 4 (Línea media hasta el día 90)
    # 3 (Línea media a las 72 horas)
    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) 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 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Belgium
    Brazil
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Portugal
    Russian Federation
    Spain
    Switzerland
    Taiwan
    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
    Última visita del último paciente.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 102
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 578
    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 severe cerebral Edema following Large Hemispheric Infarction and this is most likely to be in an emergency setting.
    Un sub grupo de sujetos puede no poder dar el consentimiento al estar incapacitados como el resultado del edema cerebral grave tras el infarto hemisférico maligno y esté lo más probable en un entorno de urgencias.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 680
    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 se preve suministro del medicamento del estudio despues del ensayo
    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 Decision2018-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-25
    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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