Selfotel in acute ischemic stroke: Possible neurotoxic effects of an NMDA antagonist

Abstract

Background and Purpose - Based on neuroprotective efficacy in animal models, we evaluated the N-methyl D-aspartate antagonist Selfotel in patients with ischemic stroke, after doses up to 1.5 mg/kg were shown to be safe in phase I and phase 2a studies. Methods - Two pivotal phase 3 ischemic stroke trials tested the hypothesis, by double-blind, randomized, placebo-controlled parallel design, that a single intravenous 1.5 mg/kg dose of Selfotel, administered within 6 hours of stroke onset, would improve functional outcome at 90 days, defined as the proportion of patients achieving a Barthel Index score of ≥60. The trials were performed in patients aged 40 to 85 years with acute ischemic hemisph..