Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction
Lead PI: Prof Bruce Campbell
Status: Recruiting
No. of Patients Currently Recruited: No. of Patients Required: 680
This is a Phase 3, randomised, double-blinded, placebo controlled, parallel-group, multi-center study to evaluate the efficacy and safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction. The primary aim is to determine if Glibenclamide improves functional outcome compared to a placebo in patients with Large Hemispheric Infarction (LHI) at Day 90.The secondary aim is to determine if Glibenclamide improves overall survival at Day 90, as well as reduce the midline shift when compared to the placebo. The safety and tolerability of Glibenclamide will be evaluted in participants with LHI.
Trial URL:
https://clinicaltrials.gov/ct2/show/NCT02864953
