CHARM: Glibenclamide for Large Hemispheric Infarction Analyzing mRS and Mortality. A Multicenter Double-Blind Placebo-Controlled Randomized Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Severe Cerebral Ed

Brief description of study

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 did not cause serious side effects or discomfort, and may reduce brain swelling, disability, and death in subjects with LHI. The purpose of this study is to investigate the study drug in a larger number of subjects (hundreds) to know more about it. The study drug is an experimental drug which means that the study drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA). 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.

Clinical Study Identifier: s18-00290 Identifier: NCT02864953
Principal Investigator: Kara R Melmed.
Other Investigator: Ariane K. Lewis.

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