Lubeluzole in Acute Ischemic Stroke

Publisher Website
Google Scholar
Abstract
Background and Purpose We aimed to assess the safety and efficacy of lubeluzole in patients with a clinical diagnosis of acute (<6 hours) ischemic stroke in the carotid artery territory. Methods A randomized, double-blind, placebo-controlled multicenter trial was conducted in 232 patients. Because treatment was administered within 6 hours and a CT scan was not mandatory before the start of treatment, 39 patients with either an intracerebral hemorrhage or ischemic stroke in the vertebrobasilar circulation were excluded from the primary efficacy analysis as prespecified in the protocol. Of the 193 patients with acute ischemic stroke in the carotid artery territory (target population), 61 received placebo, 66 lubeluzole 7.5 mg over 1 hour followed by 10 mg/d for 5 days, and 66 lubeluzole 15 mg over 1 hour followed by 20 mg/d for 5 days. Results The trial, initially aimed at a patient inclusion of 270, was terminated prematurely according to the advice of the Safety Committee because of an imbalance in mortal...

This publication has 4 references indexed in Scilit: