Brief description of trial (Data source: 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.
Health conditions investigated(Data source: BASEC)
grande infarto emisferico
Health conditions
(Data source: WHO)
Brain Edema;Stroke, Acute
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Il trattamento dello studio verrà somministrato una volta attraverso un ago nella vena. Sarà somministrato ininterrottamente per 72 ore (3 giorni).
Interventions
(Data source: WHO)
Drug: BIIB093;Drug: Placebo
Criteria for participation in trial
(Data source: 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
Exclusion criteria
(Data source: 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
(Data source: 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
-
Further information on trial
Recruitment status
Terminated
Academic title
(Data source: 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 of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Part 1: Percentage of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS)
Secundary end point
(Data source: 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 information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Aarau, Bern, Lugano
Countries
(Data source: 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 for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. Carlo Cereda
+41 91 811 66 91
Carlo.Cereda@eoc.ch
Contact for general information
(Data source: WHO)
Medical Director
Biogen
Contact for scientific information
(Data source: WHO)
Medical Director
Biogen
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Comitato etico cantonale Ticino
Date of authorisation by the ethics committee
11.12.2018
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2018-01727
Secondary ID (Data source: WHO)
RPI 301
2017-004854-41
252LH301
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