BACKGROUND AND PURPOSE: NXY-059 is a free radical-trapping neuroprotectant 
demonstrated to reduce disability from ischemic stroke. We conducted analyses on 
additional end points and sensitivity analyses to confirm our findings.
METHODS: We randomized 1722 patients with acute ischemic stroke to a 72-hour 
infusion of placebo or intravenous NXY-059 within 6 hours of stroke onset. The 
primary outcome was disability at 90 days, as measured by the modified Rankin 
Scale (mRS), a 6-point scale ranging from 0 (no residual symptoms) to 5 
(bed-bound, requiring constant care). Additional and exploratory analyses 
included mRS at 7 and 30 days; subgroup interactions with final mRS; assessments 
of activities of daily living by Barthel index; and National Institutes of 
Health Stroke Scale (NIHSS) neurological scores at 7 and 90 days.
RESULTS: NXY-059 significantly improved the distribution of the mRS disability 
score compared with placebo at 7, 30, and 90 days (Cochran-Mantel-Haenszel test 
P=0.002, 0.004, 0.038, respectively; 90-day common odds ratio 1.20; 95% CI, 1.01 
to 1.42). The benefit was not attributable to any specific baseline 
characteristic, stratification variable or subgroup interaction. Neurological 
scores were improved at 7 days (odds ratio [OR], 1.46; 95% CI, 1.13, 1.89; 
P=0.003) and the Barthel index was improved at 7 and 30 days (OR, 1.55; 95% CI, 
1.22, 1.98; P<0.0001; OR, 1.27; 95% CI, 1.01, 1.59; P=0.02).
CONCLUSIONS: NXY-059 within 6 hours of acute ischemic stroke significantly 
reduced disability. Benefit on neurological scores and activities of daily 
living was detectable early but not significant at 90 days; however, our trial 
was underpowered to measure effects on the neurological examination. The benefit 
on disability is not confounded by interactions and is supported by other 
outcome measures.