PMID: 9444444Jan 28, 1998Paper

Safety and pharmacokinetics of the neuroprotective drug lubeluzole in patients with ischemic stroke

Clinical Therapeutics
J De KeyserJ van Gorp

Abstract

A total of 22 patients with acute ischemic stroke participated in two randomized, single-masked, placebo-controlled studies that evaluated the safety and pharmacokinetics of single escalating intravenous doses of lubeluzole. The first dose of study medication in all patients was given within 6 hours of the first sign of stroke onset. In the first study, 6 patients received a single 1-hour intravenous infusion of 5 mg of lubeluzole; 4 of these patients received an additional 10-mg dose 3 to 4 days later. Two additional patients received placebo. In the second study, 4 patients received a single 1-hour infusion of 10 mg of lubeluzole, and 2 patients received placebo. After a safety evaluation of the second study, 6 additional patients received 15 mg of lubeluzole, and 2 other patients received placebo. Lubeluzole had no clinically relevant effects on any cardiovascular variable compared with placebo. The majority of adverse experiences were mild to moderate and resolved during treatment. No unexpected electroencephalogram abnormalities were observed, and no evidence of epileptiform discharges was found in any of the patients. At the end of the infusion, plasma lubeluzole concentrations decayed biphasically, with mean distribution...Continue Reading

References

Jan 1, 1977·Stroke; a Journal of Cerebral Circulation·J AstrupN A Lassen
May 1, 1992·Epilepsia·M Kotila, O Waltimo
Nov 1, 1981·Stroke; a Journal of Cerebral Circulation·J AstrupL Symon
May 1, 1994·Stroke; a Journal of Cerebral Circulation·P GideonO Henriksen
Apr 1, 1993·Stroke; a Journal of Cerebral Circulation·E Faught

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Citations

Aug 15, 2003·The Cochrane Database of Systematic Reviews·K W Muir, K R Lees
Mar 1, 2002·The Cochrane Database of Systematic Reviews·C GandolfoM Conti
Apr 9, 2014·ACS Chemical Neuroscience·Garam LeeVasanthi Jayaraman
Sep 1, 2021·Clinical and Translational Science·Michael E ManiskasJustin F Fraser

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