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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

This is a Phase 3 study, which means that BIIB093 (study drug) has already been investigated in previous clinical research studies with a small number of people with large hemispheric infarction (LHI). These studies suggested that the study drug was safe, did not cause serious side effects or discomfort, and may reduce brain swelling, disability, and death in subjects with LHI. In this study, we want to investigate the study drug in a larger number of subjects (hundreds) to know more about it. LHI is a type of stroke. An ischemic stroke occurs when blood flow to parts of the brain is blocked, such as by a blood clot. This can cause damage to the brain. In LHI a large portion of the brain is damaged. People who have LHI can develop swelling of the brain called cerebral edema, which can worsen the symptoms and outcomes of LHI. Currently, there are no medications available to specifically reduce brain swelling caused by LHI. In this study, we want to investigate how well the study drug works to improve functional outcomes (the ability to do normal daily activities, such as walking and getting dressed) in subjects with LHI. This study will also look at the long-term effects of the study drug over time and see how safe the study drug is.
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
A clinical diagnosis of acute ischemic stroke in the MCA territory within 10 hours of symptom onset
Aged 18 to 85 years old, inclusive, at the time of informed consent
Screening NIHSS ≥10
Exclusion Criteria:
In the judgment of the Investigator, the subject is likely to have supportive care withdrawn in the first day
Commitment to decompressive craniectomy (DC) prior to enrollment
Evidence (clinical or imaging) of concurrent infarction in the contralateral hemisphere deemed by the Investigator to be sufficiently serious so as to affect functional outcome
Clinical signs of herniation and/or loss of other brain stem reflexes, attributable to edema or herniation according to the Investigator’s judgment
Brain hemorrhage (other than small petechial/punctate hemorrhages) on NCCT/MRI
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Hershey, PA