Safety and efficacy of otaplimastat in patients with acute ischemic stroke requiring tPA (SAFE-TPA): A multicenter, randomized, double-blind, placebo-controlled phase 2 study
Annals of Neurology Jan 23, 2020
Kim JS, Lee KB, Park JH, et al. – Researchers conducted a phase 2, two-part, multicenter trial involving stroke survivors aged 19-80 years receiving recombinant tissue plasminogen activator (rtPA) to determine the safety and efficacy of otaplimastat in this rtPA-treated patients. For this investigation, intravenous otaplimastat was given < 30 minutes after rtPA. During stage 1, all individuals received otaplimastat 80 mg. Patients were randomized to receive either placebo, otaplimastat 40 mg, or otaplimastat 80 mg for stage 2 via a computer-generated allocation sequence. In patients receiving rtPA, intravenous otaplimastat adjunctive therapy was found to be feasible and generally safe. Adverse events of chills, muscle rigidity, and hepatotoxicity were found to be otaplimastat related. The researchers concluded that otaplimastat's functional efficacy needs to be investigated with additional large trials.
-
Exclusive Write-ups & Webinars by KOLs
-
Daily Quiz by specialty
-
Paid Market Research Surveys
-
Case discussions, News & Journals' summaries