NXY-059 for acute ischemic stroke

TL;DR: The administration of NXY-059 within six hours after the onset of acute ischemic stroke significantly improved the primary outcome (reduced disability at 90 days), but it did not significantly improve other outcome measures, including neurologic functioning as measured by the NIHSS score.

Abstract: Background NXY-059 is a free-radical–trapping agent that is neuroprotective in animal models of stroke We tested whether it would reduce disability in humans after acute ischemic stroke Methods We conducted a randomized, double-blind, placebo-controlled trial involving 1722 patients with acute ischemic stroke who were randomly assigned to receive a 72-hour infusion of placebo or intravenous NXY-059 within 6 hours after the onset of the stroke The primary outcome was disability at 90 days, as measured according to scores on the modified Rankin scale for disability (range, 0 to 5, with 0 indicating no residual symptoms and 5 indicating bedbound, requiring constant care) Results Among the 1699 subjects included in the efficacy analysis, NXY-059 significantly improved the overall distribution of scores on the modified Rankin scale, as compared with placebo (P=0038 by the Cochran–Mantel–Haenszel test) The common odds ratio for improvement across all categories of the scale was 120 (95 percent confidence