Sygen in Acute Stroke Study "SASS"

Completed

Phase 3 Results

Trial Description

To assess the safety and efficacy of ganglioside GM1 in acute anterior circulation ischemic stroke.

Interventions

  • GM1 ganglioside (Sygen┬«)Drug
    Intervention Desc: GM-1 ganglioside occurs naturally in brain and has neuroprotective actions in experimental models. Mechanism uncertain.

Trial Design

Randomized, double-blind, placebo-controlled, parallel-treatment clinical trial involving 287 patients at 13 centers.

Patient Involvement

Patients received 100 mg GM1 or placebo intramuscularly daily for 28 days and were evaluated regularly for 84 days.

Outcomes

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.

Sponsors

Fidia Pharmaceutical Corporation