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    Summary
    EudraCT Number:2017-004854-41
    Sponsor's Protocol Code Number:252LH301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, multicentrico, volto a valutare l’efficacia e la sicurezza di BIIB093 somministrato per via endovenosa (glibenclamide) per l’edema cerebrale grave in seguito a infarto emisferico massivo
    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.
    Studio per valutare l'utilizzo del farmaco sperimentale BIIB093 verso placebo in pazienti con infarto emisferico massivo
    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
    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 number000000
    B.5.5Fax number000000
    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 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.3.9.4EV 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.8.4Route 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 cerebrale a seguito di infarto emisferico massivo
    E.1.1.1Medical condition in easily understood language
    Brain swelling after stroke
    Gonfiore del cervello a seguito di stroke
    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).
    L’obiettivo primario è determinare se BIIB093 migliora l’esito funzionale al Giorno 90, misurato mediante la scala di Rankin modificata (mRS), rispetto al placebo nei soggetti con LHI
    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.
    Gli obiettivi secondari sono determinare se BIIB093 migliora la sopravvivenza complessiva al Giorno 90 rispetto al placebo, se BIIB093 migliora l’esito funzionale al Giorno 90 sulla mRS dicotomizzata 0-4 vs 5-6, rispetto al placebo, se BIIB093 riduce lo spostamento della linea mediana a 72 ore (o al momento della craniectomia decompressiva [DC] o delle sole misure di conforto [CMO], se precedente) rispetto al placebo, e Valutare la sicurezza e la tollerabilità di BIIB093 nei soggetti con LHI.
    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. Diagnosi clinica di ictus ischemico acuto nel territorio dell’arteria cerebrale media (ACM)
    2. Infarto emisferico massivo definito come: volume della lesione compreso tra 80 e 300 centimetri cubi (cm^3) alla risonanza magnetica (RM) con immagini pesate in diffusione (DWI) o alla perfusione tomografica computerizzata (CTP), oppure un punteggio TC precoce del Programma Alberta sull’ictus (ASPECTS) compreso tra 1 e 5 con coinvolgimento di almeno 2 regioni corticali definite
    3. Punteggio della Scala dell’ictus del National Institutes of Health (NIHSS) allo screening >=10
    4. Infusione del trattamento in studio entro 10 ore dopo il momento di esordio dei sintomi, se noto, o l’ultimo momento di normalità nota
    5. Per i partecipanti sottoposti a trombectomia, l’inclusione nello studio deve basarsi sulla RM-DWI post-trombectomia.
    NOTA: possono essere applicati altri criteri di inclusione definiti dal protocollo
    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. Probabile interruzione delle cure di supporto prestate al partecipante in occasione del primo giorno
    2. Craniectomia decompressiva (CD) prevista prima dell’arruolamento
    3. Evidenza di infarto concomitante nell’emisfero controlaterale sufficientemente grave da influire sugli esiti funzionali
    NOTA: possono essere applicati altri criteri di inclusione definiti dal protocollo
    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)
    Percentuale di partecipanti con miglioramento nell’esito funzionale al Giorno 90 valutato mediante la Scala modificata di Rankin (mRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline up to Day 90
    dal basale al Giorno 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. Tempo al decesso per qualsiasi causa [intervallo di tempo: dal basale al Giorno 90]
    2. Percentuale di partecipanti che hanno raggiunto un punteggio mRS di 0-4 al Giorno 90 [intervallo di tempo: dal basale al Giorno 90]
    3. Riduzione nello spostamento della linea mediana a 72 ore [intervallo di tempo: dal basale a 72 ore]
    4. Incidenza di eventi avversi (EA) ed eventi avversi seri (SAE) [intervallo di tempo: dal basale al Giorno 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)
    # 1, 2 e 4 (dal basale al Giorno 90) #3 (dal basale a 72 ore)
    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 concerned7
    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 Information not present in EudraCT
    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
    Czechia
    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
    LVLS
    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 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.
    I pazienti di un sottogruppo potrebbero non essere in grado di fornire il consenso a causa della loro incapacità a causa del grave edema cerebrale conseguente ad un infarto emisferico massivo è quindi probabile che ci si trovi in una situazione di em
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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
    Non vi è l'intezione di fornire il trattamento di studio dopo lo studio
    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 Decision2018-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-29
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