Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals
Status:
Completed
Trial end date:
2016-04-04
Target enrollment:
Participant gender:
Summary
This is a randomized, multi-center, prospective, double blind study. The primary objective is
to assess the efficacy and safety of glyburide (RP-1127) compared to placebo in participants
with a severe anterior circulation ischemic stroke who are likely to develop malignant
edema.This objective will be addressed by comparing the proportion of glyburide treated
particpants and placebo treated participants with a Day 90 modified Rankin Scale (mRS) ≤ 4
without decompressive craniectomy (DC). The secondary objective is to assess the efficacy of
RP-1127 compared to placebo in participants with a severe anterior circulation ischemic
stroke who were likely to develop malignant edema.