Brève description de l’étude (Source de données: BASEC)
Lo scopo di questo studio è determinare se BIIB093 migliori gli esiti funzionali (la capacità di svolgere le normali attività quotidiane, come camminare e vestirsi) dei partecipanti che hanno avuto un tipo di ictus, chiamato infarto emisferico esteso , rispetto al placebo dopo 90 giorni. Questo studio esaminerà anche la sopravvivenza a 90 giorni e verificherà la sicurezza e tollerabilità di BIIB093.
Prenderanno parte a questo studio circa 680 partecipanti in tutto il mondo.
Maladies étudiées(Source de données: BASEC)
grande infarto emisferico
Health conditions
(Source de données: WHO)
Brain Edema;Stroke, Acute
Maladie rare
(Source de données: BASEC)
Non
Intervention étudiée (p. ex., médicament, thérapie, campagne)
(Source de données: BASEC)
Il trattamento dello studio verrà somministrato una volta attraverso un ago nella vena. Sarà somministrato ininterrottamente per 72 ore (3 giorni).
Interventions
(Source de données: WHO)
Drug: BIIB093;Drug: Placebo
Critères de participation à l’étude
(Source de données: BASEC)
- Una diagnosi clinica di ictus ischemico acuto nel territorio dell’arteria cerebrale media.- Età compresa tra 18 e 85 anni, compresi.
- Screening National Institutes of Health Stroke Scale (NIHSS) ≥10
- Infusione del trattamento dello studio entro 10 ore dall’insorgenza dei sintomi o dal visto sano l’ultima volta.
- Prima del colpo attuale, nessuna disabilità significativa
Critères d’exclusion
(Source de données: BASEC)
1. Probabilità di ritiro di cure di supporto nel primo giorno.
2. Impegno per la craniectomia decompressiva prima dell'arruolamento.
3. Evidenza di infarto concomitante nell'emisfero controlaterale sufficientemente serio da influire sull'esito funzionale.
Inclusion/Exclusion Criteria
(Source de données: WHO)
Gender: All
Maximum age: 85 Years
Minimum age: 18 Years
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. At the time of randomization, and in the Investigator's judgement, it must be feasible
for study drug treatment infusion to be initiated no later than 10 hours after time of
symptom onset, if known, or the time last known normal.
- Participants who wake with stroke may be included if neurological and other
exclusion criteria are satisfied. The time of stroke onset is to be taken as the
midpoint between sleep onset (or last known to be normal) and time of waking.
5. For participants who receive thrombectomy, inclusion into the study must be based on
post-thrombectomy MRI-DWI.
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 Inclusion/Exclusion criteria may apply
-
Plus d’informations sur l’étude
Statut de recrutement
Terminated
Titre scientifique
(Source de données: WHO)
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
Type d’étude
(Source de données: WHO)
Interventional
Conception de l’étude
(Source de données: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Source de données: WHO)
Phase 3
Points finaux primaires
(Source de données: WHO)
Part 1: Percentage of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS)
Points finaux secondaires
(Source de données: WHO)
Part 1: Time to All-Cause Death;Part 1: Number of Participants Who Achieved mRS 0-4 at Day 90;Part 1: Reduction in Midline Shift at 72 Hours;Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Contact pour informations
(Source de données: WHO)
Please refer to primary and secondary sponsors
Résultats de l’étude
(Source de données: WHO)
Résumé des résultats
pas encore d’informations disponibles
Lien vers les résultats dans le registre primaire
pas encore d’informations disponibles
Informations sur la disponibilité des données individuelles des participants
pas encore d’informations disponibles
Lieux de réalisation des études
Lieux de réalisation des études en Suisse
(Source de données: BASEC)
Aarau, Berne, Lugano
Pays où sont réalisées les études
(Source de données: WHO)
Australia, Belgium, Brazil, Canada, China, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Korea, Lithuania, Portugal, Republic of, Russian Federation, Spain, Switzerland, Taiwan, United Kingdom, United States
Contact pour plus d’informations sur l’étude
Données sur la personne de contact en Suisse
(Source de données: BASEC)
Dr. Carlo Cereda
+41 91 811 66 91
Carlo.Cereda@eoc.ch
Contact pour des informations générales
(Source de données: WHO)
Medical Director
Biogen
Contact pour des informations scientifiques
(Source de données: WHO)
Medical Director
Biogen
Autorisation de la commission d’éthique (Source de données: BASEC)
Nom de la commission d’éthique chargée de l’autorisation (dans le cas d’études multicentriques, uniquement la commission directrice)
Comitato etico cantonale Ticino
Date d’autorisation de la commission d’éthique
11.12.2018
Plus de numéros d’identification d’étude
Numéro d’identification de l’étude de la commission d’éthique (BASEC-ID)
(Source de données: BASEC)
2018-01727
Secondary ID (Source de données: WHO)
RPI 301
2017-004854-41
252LH301
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