BACKGROUND: Patients with large territory infarction are at high risk of 
cerebral edema and neurological deterioration, including death. Preclinical 
studies have shown that a continuous infusion of glyburide blocks edema 
formation and improves outcome. We hypothesize that treatment with RP-1127 
(Glyburide for Injection) reduces formation of brain edema in patients after 
large anterior circulation infarction.
METHODS: GAMES-RP is a prospective, randomized, double-blind, multicenter trial 
designed to evaluate RP-1127 in patients at high risk for the development of 
malignant cerebral edema. The study population consisted of subjects with a 
clinical diagnosis of acute severe anterior circulation ischemic stroke with a 
baseline diffusion-weighted image lesion between 82 and 300 cm(3) who are 
18-80 years of age. The target time from symptom onset to start of study 
infusion was ≤10 h. Subjects were randomized to RP-1127 (glyburide for 
injection) or placebo and treated with a continuous infusion for 72 h.
RESULTS: The primary efficacy outcome was a composite of the modified Rankin 
Scale and the incidence of decompressive craniectomy, assessed at 90 days. 
Safety outcomes were the frequency and severity of adverse events, with a focus 
on cardiac- and glucose-related serious adverse events.
CONCLUSIONS: GAMES-RP was designed to provide critical information regarding 
glyburide for injection in patients with large hemispheric stroke and will 
inform the design of future studies.