Ganglioside GM1 in acute ischemic stroke: The SASS trial

The SASS Investigators

Research output: Contribution to journalArticle

52 Citations (Scopus)

Abstract

Background and Purpose We sought to assess the safety and efficacy of ganglioside GM1 in acute (≤48 hours), anterior circulation ischemic stroke. Methods We screened more than 5000 patients at 13 centers in a randomized, doubie-blind, placebo-controlled, parallel-treatment, clinical trial and enrolled 287 patients. They received 100 mg GM1 or placebo intramuscularly daily for 28 days and were evaluated regularly for 84 days. Number of deaths, the Toronto Stroke Scale, and the Barthel Index were primary outcomes; improvements on the Fugl-Meyer Scale and on a neuropsychological battery were secondary outcomes. Results The groups were balanced for severity, side of stroke, age, sex, race, years of schooling, prior illness, and depression scores. Analyzable data were available on 275 patients; 217 patients completed the trial. Protocol-specified primary and secondary outcome measures showed no signifi­cant difference between treatment arms. However, 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. Conclusions GM1 is safe. However, since only certain post hoc tests showed statistically significant differences or trends favoring GM1, another clinical trial is needed to demonstrate efficacy.

Original languageEnglish (US)
Pages (from-to)1141-1148
Number of pages8
JournalStroke
Volume25
Issue number6
StatePublished - 1994

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G(M1) Ganglioside
Stroke
Placebos
Clinical Trials
Neuropsychological Tests
Therapeutics
Outcome Assessment (Health Care)
Depression
Safety

Keywords

  • Cerebral ischemia
  • Clinical trials
  • Gangliosides

ASJC Scopus subject areas

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

Cite this

The SASS Investigators (1994). Ganglioside GM1 in acute ischemic stroke: The SASS trial. Stroke, 25(6), 1141-1148.

Ganglioside GM1 in acute ischemic stroke : The SASS trial. / The SASS Investigators.

In: Stroke, Vol. 25, No. 6, 1994, p. 1141-1148.

Research output: Contribution to journalArticle

The SASS Investigators 1994, 'Ganglioside GM1 in acute ischemic stroke: The SASS trial', Stroke, vol. 25, no. 6, pp. 1141-1148.
The SASS Investigators. Ganglioside GM1 in acute ischemic stroke: The SASS trial. Stroke. 1994;25(6):1141-1148.
The SASS Investigators. / Ganglioside GM1 in acute ischemic stroke : The SASS trial. In: Stroke. 1994 ; Vol. 25, No. 6. pp. 1141-1148.
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abstract = "Background and Purpose We sought to assess the safety and efficacy of ganglioside GM1 in acute (≤48 hours), anterior circulation ischemic stroke. Methods We screened more than 5000 patients at 13 centers in a randomized, doubie-blind, placebo-controlled, parallel-treatment, clinical trial and enrolled 287 patients. They received 100 mg GM1 or placebo intramuscularly daily for 28 days and were evaluated regularly for 84 days. Number of deaths, the Toronto Stroke Scale, and the Barthel Index were primary outcomes; improvements on the Fugl-Meyer Scale and on a neuropsychological battery were secondary outcomes. Results The groups were balanced for severity, side of stroke, age, sex, race, years of schooling, prior illness, and depression scores. Analyzable data were available on 275 patients; 217 patients completed the trial. Protocol-specified primary and secondary outcome measures showed no signifi­cant difference between treatment arms. However, 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. Conclusions GM1 is safe. However, since only certain post hoc tests showed statistically significant differences or trends favoring GM1, another clinical trial is needed to demonstrate efficacy.",
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T1 - Ganglioside GM1 in acute ischemic stroke

T2 - The SASS trial

AU - The SASS Investigators

AU - Alter, Milton

AU - Bell, R.

AU - Brass, L.

AU - Gaines, K.

AU - Goldstein, L.

AU - Hollander, J.

AU - Jozefczyk, P.

AU - Kelley, R.

AU - Mayman, C.

AU - Miller, A.

AU - Pascuzzi, Robert

AU - Ramirez-Lassepas, M.

AU - Rosenbaum, D.

AU - Zachariah, S.

AU - Brennan, R.

AU - Chawluk, J.

AU - Furlan, A.

AU - Mellits, D.

PY - 1994

Y1 - 1994

N2 - Background and Purpose We sought to assess the safety and efficacy of ganglioside GM1 in acute (≤48 hours), anterior circulation ischemic stroke. Methods We screened more than 5000 patients at 13 centers in a randomized, doubie-blind, placebo-controlled, parallel-treatment, clinical trial and enrolled 287 patients. They received 100 mg GM1 or placebo intramuscularly daily for 28 days and were evaluated regularly for 84 days. Number of deaths, the Toronto Stroke Scale, and the Barthel Index were primary outcomes; improvements on the Fugl-Meyer Scale and on a neuropsychological battery were secondary outcomes. Results The groups were balanced for severity, side of stroke, age, sex, race, years of schooling, prior illness, and depression scores. Analyzable data were available on 275 patients; 217 patients completed the trial. Protocol-specified primary and secondary outcome measures showed no signifi­cant difference between treatment arms. However, 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. Conclusions GM1 is safe. However, since only certain post hoc tests showed statistically significant differences or trends favoring GM1, another clinical trial is needed to demonstrate efficacy.

AB - Background and Purpose We sought to assess the safety and efficacy of ganglioside GM1 in acute (≤48 hours), anterior circulation ischemic stroke. Methods We screened more than 5000 patients at 13 centers in a randomized, doubie-blind, placebo-controlled, parallel-treatment, clinical trial and enrolled 287 patients. They received 100 mg GM1 or placebo intramuscularly daily for 28 days and were evaluated regularly for 84 days. Number of deaths, the Toronto Stroke Scale, and the Barthel Index were primary outcomes; improvements on the Fugl-Meyer Scale and on a neuropsychological battery were secondary outcomes. Results The groups were balanced for severity, side of stroke, age, sex, race, years of schooling, prior illness, and depression scores. Analyzable data were available on 275 patients; 217 patients completed the trial. Protocol-specified primary and secondary outcome measures showed no signifi­cant difference between treatment arms. However, 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. Conclusions GM1 is safe. However, since only certain post hoc tests showed statistically significant differences or trends favoring GM1, another clinical trial is needed to demonstrate efficacy.

KW - Cerebral ischemia

KW - Clinical trials

KW - Gangliosides

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