Sygen in Acute Stroke Study "SASS"


Phase 3 Results


Primary and secondary outcome measures showed no significant difference between treatment arms. Improvement from baseline in the motor component of the Toronto Stroke Scale favored the GM1-treated group at day 28 when GM1 treatment stopped (P =.020); at day 84, the difference still favored the GM1- treated group (P = .057). All 10 components of the Barthel Index, the Fugl-Meyer Scale, and four of the five tests in the neuropsychological battery also favored the GM1 group. Adverse experiences were similar in the two groups.