Abstract
Objective: Oxidative stress due to free radicals is thought to contribute to the pathogenesis of amyotrophic lateral sclerosis (ALS). A short–term placebo–controlled double blind study was performed to examine the efficacy and safety of a free radical scavenger, edaravone, in the treatment of ALS.
Methods: Patients underwent intravenous drip–infusion of edaravone (n＝20) or placebo (n＝20) for 20 weekdays in 4 weeks. After a subsequent medication–free phase for 2 weeks, all patients underwent intravenous drip–infusion of edaravone for 14 days.
Results: No significant differences in the ALSFRS–R score and ％FVC were observed between the edaravone and placebo groups. In patients with ALSFRS–R scores equal to or more than 41 as an exploratory analysis, the ALSFRS–R scores and ％FVC improved significantly in the edaravone group compared with the placebo group. Edaravone was shown to be safe for patients with ALS.
Conclusions: The results of this study also suggest that edaravone ameliorates the respiratory and motor function symptoms in early stage (lower severity grades) ALS patients.
