To assess the safety and efficacy of ganglioside GM1 in acute anterior circulation ischemic stroke.
- GM1 ganglioside (Sygen®)Drug
Intervention Desc: GM-1 ganglioside occurs naturally in brain and has neuroprotective actions in experimental models. Mechanism uncertain.
Randomized, double-blind, placebo-controlled, parallel-treatment clinical trial involving 287 patients at 13 centers.
Patients received 100 mg GM1 or placebo intramuscularly daily for 28 days and were evaluated regularly for 84 days.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Number of deaths, the Toronto Stroke Scale as measured at enrollment, and the Barthel Index at day 7. Reassessments were made at days 7, 21, 28, 56, and 84 after enrollment.|
|Secondary||Improvements on the Fugl-Meyer Scale and on a neuropsychological battery after 3 days of treatment.|