Abstract 211: GAMES (Glyburide Advantage in Malignant Edema and Stroke) Pilot Study

• DOI: 10.1161/str.44.suppl_1.a211
• Publication Date: 2022-03-20T05:12:15Z
• Authors: Kevin N Sheth; W. T Kimberly; Jordan Elm; Karen Yarbrough; Sydney O'Connor; Maxim Hammer; April Kane; Katharina Busl; Terry Cole; Albert J Yoo; Sven Jacobson; Barney Stern
• Keywords: Stroke; Bolus (digestion); Cerebral edema

Introduction: Malignant infarction is characterized by the formation of cerebral edema, and decompressive craniectomy (DC) only proven therapy. The NC (Ca-ATP) channel, regulated SUR1 receptor, blocked sulfonylurea drug glyburide, which attenuates brain water content in preclinical models large stroke. A phase I study has been safely completed. We assessed hypothesis that a pilot RP-1127 (Glyburide for Injection) patients at high risk malignant was safe feasible. Methods: objective this four-center prospective, open label, IIa trial to assess safety feasibility treating severe anterior circulation ischemic stroke with RP-1127, whether or not treated IV rtPA. enrolled baseline MRI DWI lesion between 82 cm3 210 cm3, age 18-80 years, time from symptom onset infusion ≤ 10 hours. Patients received bolus followed continuous 72 Results: Recruitment completed within 9.6 months. mean initial volume 102 ± 23 cm3. There were no serious adverse events related drug. incidence edema 20%, compared 88% prospective observational ≥82 Further, 8/10 did require any osmotherapy DC. increase ipsilateral hemisphere 50±33 historical controls 71.5±27 proportion 30 day mRS 4 90% 23.8% (at 12 months) control pooled analysis DC trials. Conclusions: These findings suggest Phase II feasible will provide important insights into potential efficacy RP-1127.