Safety and Efficacy of Two Doses of SP-8203 in Patients With Ischemic Stroke Requiring rtPA

Summary

The current study aims to evaluate the safety of SP-8203, designing in two stages (stage-1, stage-2) to evaluate the safety and efficacy of the combination therapy of SP-8203 and rtPA for the occurrence of cerebral hemorrhage in patients with acute ischemic stroke receiving rtPA standard of care.

Timeline

Start

2016-06-05

Primary completion

2017-05-30

Completion

2017-08-22

Publications

• Kim JS, Lee KB, Park JH, Sung SM, Oh K, Kim EG, Chang DI, Hwang YH, Lee EJ, Kim WK, Ju C, Kim BS, Ryu JM; SAFE-TPA Investigators. 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. Ann Neurol. 2020 Feb;87(2):233-245. doi: 10.1002/ana.25644. Epub 2019 Nov 29.

Drugs

Indications