title: Early treatment of stroke with monosialoganglioside GM-1. Efficacy and safety results of the Early Stroke Trial.
abstract: OBJECTIVE
  The Early Stroke Trial (EST) is a randomized, double-blind, placebo-controlled 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 mg GM-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 = .06). 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.
authors.affiliation: Department of Neurological Sciences, University of Rome La Sapienza, Italy.
authors.forename: G L
authors.initials: GL
authors.lastname: Lenzi
authors.forename: F
authors.initials: F
authors.lastname: Grigoletto
authors.forename: M
authors.initials: M
authors.lastname: Gent
authors.forename: R S
authors.initials: RS
authors.lastname: Roberts
authors.forename: M D
authors.initials: MD
authors.lastname: Walker
authors.forename: J D
authors.initials: JD
authors.lastname: Easton
authors.forename: A
authors.initials: A
authors.lastname: Carolei
authors.forename: F C
authors.initials: FC
authors.lastname: Dorsey
authors.forename: W A
authors.initials: WA
authors.lastname: Rocca
authors.forename: R
authors.initials: R
authors.lastname: Bruno
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002561:Cerebrovascular Disorders / Q000188:drug therapy* / Q000401:mortality; D004311:Double-Blind Method; D005260:Female; D005677:G(M1) Ganglioside / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012449:Safety
chemical_list: D005677:G(M1) Ganglioside