Biogen CHARM 252LH301
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.