TY - JOUR
T1 - Ganglioside GM1 in acute ischemic stroke
T2 - The SASS trial
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, R.
AU - Ramirez-Lassepas, M.
AU - Rosenbaum, D.
AU - Zachariah, S.
AU - Brennan, R.
AU - Chawluk, J.
AU - Furlan, A.
AU - Mellits, D.
PY - 1994/6
Y1 - 1994/6
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
UR - http://www.scopus.com/inward/record.url?scp=0028450967&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0028450967&partnerID=8YFLogxK
U2 - 10.1161/01.STR.25.6.1141
DO - 10.1161/01.STR.25.6.1141
M3 - Article
C2 - 8202971
AN - SCOPUS:0028450967
SN - 0039-2499
VL - 25
SP - 1141
EP - 1148
JO - Stroke
JF - Stroke
IS - 6
ER -