Early treatment of stroke with monosialoganglioside GM-1: Efficacy and safety results of the early stroke trial

Gian Luigi Lenzi, Francesco Grigoletto, Michael Gent, Robin S. Roberts, Michael D. Walker, J. Donald Easton, Antonio Carolei, Frank C. Dorsey, Walter A. Rocca, Roberto Bruno, Francesca Patarnello, Cesare Fieschi

Research output: Contribution to journalArticle

74 Scopus citations

Abstract

Background and Purpose The Early Stroke Trial (EST) is a randomized, double-blind, placebo-con trolled trial to assess the effect of monosialoganglioside GM-1 in improving recovery in patients who experienced an ischemic supratentorial stroke. Methods Sixteen clinical centers recruited 805 patients, of whom 792 were confirmed to be eligible. Treatment, consisting of a first dose of either 200 mgGM-1 or placebo, was initiated within 5 hours of the onset of stroke; a second dose of either 100 mg GM-1 or placebo was administered 12 hours later. Thereafter, patients received a daily injection of 100 mg GM-1 or placebo intravenously from day 2 through 10 and intramuscularly from day 11 through 21. Patients were followed up for a total of 4 months. Results Survival was similar in the two treatment groups. Improvement in neurological status, as measured by the change in Canadian Neurological Scale score between baseline and 4-month assessments, was greater in the group receiving GM-1; the observed difference between treatment groups was 0.22 (P =.O6). A post hoc analysis in the subgroup of patients treated within 4 hours showed a statistically significant difference, with Canadian Neurological Scale mean improvement of 0.41 (P =. 016). GM-1 use was not associated with differences in frequency, nature, or severity of adverse experiences. Conclusions These findings suggest that GM-1 is safe in the dose and treatment schedule used and that its efficacy in ischemic stroke is greater when given soon after onset of stroke.

Original languageEnglish (US)
Pages (from-to)1552-1558
Number of pages7
JournalStroke
Volume25
Issue number8
DOIs
StatePublished - Aug 1994

    Fingerprint

Keywords

  • Clinical trials
  • Gangliosides
  • Stroke management

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

Cite this

Lenzi, G. L., Grigoletto, F., Gent, M., Roberts, R. S., Walker, M. D., Donald Easton, J., Carolei, A., Dorsey, F. C., Rocca, W. A., Bruno, R., Patarnello, F., & Fieschi, C. (1994). Early treatment of stroke with monosialoganglioside GM-1: Efficacy and safety results of the early stroke trial. Stroke, 25(8), 1552-1558. https://doi.org/10.1161/01.STR.25.8.1552