The safety and tolerability of a free radical scavenger with Na+ channel blocking activity (dimethyl sulfoxide (DMSO)) combined with a glycolytic intermediate and high energy substrate (fructose 1,6-disphosphate (FDP)) were assessed in a mostly elderly patient group presenting with acute and subacute ischemic stroke. Eleven patients (average age 65) were given i.v. infusions of DMSO-FDP twice daily for an average of 12 days, while five control patients (average age 63) were given standard therapy. Safety and tolerability were evaluated by clinical adverse effects to drug therapy. Efficacy of DMSO-FDP was assessed by MRI lesion size, by magnetic resonance angiography of ischemic territory, and by a 5-point neurologic recovery scale that rated sensory-motor function and level of consciousness. Results suggest that DMSO-FDP administration is safe, well-tolerated and may be of benefit when given within 12 h after the onset of stroke symptoms. No significant changes in blood pressure, EKG, heart rate or hematology and chemistry profiles, were recorded in any patient receiving DMSO-FDP. Neurologic evaluation at 1, 3 and 6 months after treatments revealed that 7 of 11 (63%) patients given DMSO-FDP achieved 'improved' or 'markedly improved' status while 1 of 5 (20%) standard treated patients showed 'improved' status and only at the 3-month follow-up. This preliminary trial indicates that DMSO-FDP is well tolerated by this group of elderly patients and could be of benefit in reducing neurologic disability after stroke.
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