Large Hemispheric Infarction (LHI) Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallelist, Multicenter, Phase III Study Evaluating the Efficacy and Safety of Intravenous Administration of BIIB093 (Glibenburide) in the Treatment of Severe Cerebral Edema After Massive Cerebral Infarction
The current study is to assess efficacy and safety of intravenous (IV) BIIB093 to improve functional outcomes in subjects with LHI.
The current study (Study 252LH301) is a 2-part Phase 3 study to assess efficacy and safety of intravenous (IV) BIIB093 to improve functional outcomes in subjects with LHI. Part 1 is a 90-day efficacy and safety evaluable period following a 72-hour infusion of BIIB093 or matching placebo, and Part 2 is a follow-up period with study visits at Month 6 and Month 12. ;