IV glyburide for prevention of brain edema

Conduct clinical trials

Our primary focus in clinical trials is the prevention of cerebral edema, testing the hypothesis that the sulfonylurea receptor 1 (Sur1) mediates edema formation after stroke. The clinical development of the Sur1 inhibitor, intravenous glyburide, began with a Phase 2a pilot clinical trial (GAMES-Pilot Trial), which evaluated the safety and efficacy of intravenous glyburide for the prevention of edema after large hemispheric stroke. The results from this effort led to a national, randomized, multi-center, double-blind Phase 2b trial in patients with large hemispheric stroke who were likely to develop edema, GAMES-RP. As the national co-PI and biomarker coordinating center, we found evidence that intravenous glyburide may reduce brain edema. There was also a reduction in mortality and a trend toward more favorable neurological outcome. In order to definitively test efficacy, we are preparing the CHARM trial, a randomized, multi-center, double-blind Phase 3 trial, which will be conducted globally.

Related Publications:

Effect of intravenous glyburide (RP-1127) on brain swelling after large hemispheric infarction: A phase 2 randomized, double-blind, placebo-controlled clinical trial
2016
Sheth KN, Elm JJ, Molyneaux BJ, Hinson H, Beslow LA, Sze GK, Ostwaldt A-C, del Zoppo GJ, Simard JM, Jacobson S and Kimberly WT. Lancet Neurol, 15:1160-1169 (2016). view PDF
Pilot study of intravenous glyburide in patients with a large ischemic stroke
2014
  1. Sheth KN*, Kimberly WT*, Elm JJ, Kent TA, Mandava P, Yoo AJ, Thomalla G, Campbell B, Donnan GA, Davis SM, Albers GW, Jacobson S, Simard JM and Stern BJ. Stroke, 45:281-283 (2014).
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