Journal article
Ganglioside GM1 in acute ischemic stroke. The SASS Trial
Stroke (1970), v 25(6), pp 1141-1148
01 Jun 1994
PMID: 8202971
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Abstract
BACKGROUND AND PURPOSEWe sought to assess the safety and efficacy of ganglioside GM1 in acute (< or = 48 hours), anterior circulation ischemic stroke.METHODSWe screened more than 5000 patients at 13 centers in a randomized, double-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.RESULTSThe 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.CONCLUSIONSGM1 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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Details
- Title
- Ganglioside GM1 in acute ischemic stroke. The SASS Trial
- Creators
- Milton Alter - Medical College of PennsylvaniaR. Bell - Jefferson Medical CollegeL. Brass - Yale University School of MedicineK. Gaines - Semmes-Murphey ClinicL. Goldstein - Duke VA Center for Cerebrovascular ResearchJ. Hollander - Rochester General HospitalP. Jozefczyk - Allegheny Singer Research InstituteR. Kelley - University of MiamiC. Mayman - Beth Israel HospitalA. Miller - Maimonides Medical CenterR. Pascuzzi - Indiana University Medical CenterM. Ramirez-Lassepas - St Paul Ramsey Medical CenterD. Rosenbaum - Montefiore Medical CenterS. Zachariah - Bay Pines VA Medical Center, University of South FloridaR. Brennan - HersheyJ. Chawluk - Good Samaritan Regional Medical CenterA. Furlan - Cleveland Clinic FoundationD. Mellits - Johns Hopkins University
- Publication Details
- Stroke (1970), v 25(6), pp 1141-1148
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Accelerated Career Entry Bachelor of Science in Nursing (BSN)
- Web of Science ID
- WOS:A1994NP14200009
- Scopus ID
- 2-s2.0-0028450967
- Other Identifier
- 991019183956304721
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InCites Highlights
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Clinical Neurology
- Peripheral Vascular Disease