Studio randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, multicentrico, di fase 3 per valutare l’efficacia e la sicurezza di BIIB093 (glibenclamide) per via endovenosa per grave edema cerebrale in seguito a un grande infarto emisferico

Drug: BIIB093;Drug: Placebo

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 Participant is likely to have supportive care withdrawn on the first day.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