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    Summary
    EudraCT Number:2018-003858-24
    Sponsor's Protocol Code Number:252BN201
    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:2021-01-26
    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 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
    Studio di fase 2 multicentrico, in doppio cieco, multidose, controllato con placebo, randomizzato, a gruppi paralleli per valutare l’efficacia e la sicurezza di BIIB093 somministrato per via endovenosa in pazienti con contusione cerebrale
    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
    Uno studio per valutare l’efficacia e la sicurezza di BIIB093 in partecipanti con contusione cerebrale
    A.3.2Name or abbreviated title of the trial where available
    .
    .
    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.5.6E-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 INNBIIB093(Glibenclamide)
    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.8.3Pharmaceutical form of the placeboPowder 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
    contusione cerebrale
    E.1.1.1Medical condition in easily understood language
    Brain contusion
    contusione cerebrale
    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
    L’obiettivo primario dello studio è determinare se BIIB093 riduce la contusione cerebrale entro 96 ore rispetto al 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.
    Gli obiettivi secondari sono di valutare gli effetti del BIIB093 sullo stato neurologico acuto, sugli esiti funzionali e sui requisiti di trattamento, per differenziare ulteriormente il meccanismo d'azione di BIIB093 sull'espansione della contusione esaminando gli effetti differenziali sull'espansione dell'ematoma e dell'edema e per determinare se il BIIB093 migliora sopravvivenza al giorno 90 rispetto al placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 15 on the Glasgow Coma Scale (GCS)
    • Functionally independent, in the opinion of the Investigator, prior to
    index head injury.
    • Diagnosi clinica della contusione cerebrale con lesioni all'interno del parenchima cerebrale sopratentoriale per un totale> 3 ml di volume per valutazione di Investigator della TCCT allo screening.
    • Punteggio da 5 a 15 sulla Glasgow Coma Scale (GCS)
    • Funzionalmente indipendente, secondo il parere dello sperimentatore, prima dell'infortunio alla testa indice.
    E.4Principal 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 parenchyma. Cerebrospinal fluid leak in isolation is not
    exclusionary unless evidence of parenchymal penetration by an external
    force (e.g., blunt object, bullet,or depressed skull fracture).
    • 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 are
    permitted, as are nonoperative intraabdominal injuries or
    placement of noninvasive external fixation devices.
    •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 giudizio dello sperimentatore, è probabile che il partecipante ritiri l'assistenza di supporto entro 24 ore.
    • Segni clinici d' erniazione del tronco cerebrale, secondo il parere dello sperimentatore.
    • Prova NCCT o risonanza magnetica (MRI) di penetrazione parenchima cerebrale. La perdita di liquido cerebrospinale in isolamento non è esclusiva a meno che non sia stata dimostrata la penetrazione del parenchima da parte di una forza esterna (ad es. Oggetto contundente, proiettile o frattura cranica depressa).
    • Qualsiasi presenza di lesione della mesencefalo o della fossa posteriore, valutata mediante imaging e esame clinico.
    • Presenza d' una concomitante lesione del midollo spinale valutata mediante imaging e esame clinico.
    • Polytrauma (trauma intra-addominale o ortopedico) che richiede una gestione operativa / chirurgica, se nota.
    Sono consentite piccole fratture che richiedono lo splintaggio o la riduzione delle lussazioni, così come le lesioni intra-addominali non chirurgiche o o posizionamento di dispositivi di fissaggio esterni non invasivi.
    • Uso di nuovi anticoagulanti orali (NOACS, inclusi inibitori diretti della trombina come dabigatran o inibitori del fattore Xa come rivaroxaban o apixaban) nei precedenti 3 giorni precedenti la lesione, se noto.
    possono essere applicati altri criteri d' esclusione definiti dal protocollo.
    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).
    Proporzione di partecipanti con espansione della contusione.

    I partecipanti con espansione della contusione saranno determinati confrontando le immagini di base e la scansione a 96 ore o la scansione ottenuta prima di qualsiasi intervento neurochirurgico (NSx) o solo misure di comfort (CMO). NSx include craniotomia e craniectomia decompressiva (DC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between 12 hours to 96 hours of start of study treatment infusion
    Tra 12 ore e 96 ore dall'inizione dell'infusione del trattamento in studio
    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
    - Proporzione di partecipanti con miglioramento nella scala di risultati di Glasgow - estesa (GOS-E).
    - Proporzione dei partecipanti con miglioramento della scala di Rankin modificata (mRS).
    - Proporzione dei partecipanti che richiedono l'intubazione ritardata
    - Cambia da baseline nel volume dell'ematoma assoluto all'ora 24
    - Cambia dalla linea di base nel volume di Edema assoluto all'ora 96
    - Tempo al decesso per qualsiasi 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: giorno 90
    - mRS: giorno 90
    - Intubazione ritardata: giorno 1 (ora 24) a giorno 4 (ora 96)
    - Ematoma assoluto: linea di base fino al giorno 1 (ora 24)
    - Volume d' edema assoluto: baseline fino al giorno 4 (ora 96)
    - Morte per tutte le cause: baseline fino al giorno 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 concerned8
    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 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
    Israel
    Japan
    United States
    France
    Germany
    Italy
    Spain
    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 years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 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.
    I pazienti di un sottogruppo potrebbero non essere in grado di fornire il consenso a causa della loro incapacità a causa della contusione cerebrale a seguito di un trauma cerebrale e questo è più probabile che si trovi in un contesto di emergenza.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state21
    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)
    Non ci sono disposizioni pe rla fornitura del trattamento dopo lo studio
    There is no provision to provide study treatment after the study
    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 Decision2019-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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