The overall mortality rate at 12 weeks for lubeluzole-treated patients was 20.7% compared to 25.2% for placebo-treated patients (NS). Controlling for relevant covariates, the degree of neurological recovery (NIHSS) at week 12 significantly favored lubeluzole over placebo (P=.033). Lubeluzole treatment similarly resulted in significantly greater improvements in functional status (Barthel Index) (P=.038) and overall disability (Rankin Scale) (P=.034) after 12 weeks. A global test statistic confirmed that lubeluzole-treated patients had a more favorable clinical outcome at 12 weeks (P=.041). The safety profile of lubeluzole resembled that of placebo.