A safety analysis of edaravone (MCI-186) during the first six cycles (24 weeks) of amyotrophic lateral sclerosis (ALS) therapy from the double-blind period in three randomized, placebo-controlled studies.

Background: There continues to be a need for new therapies to treat ALS.

Objective: Provide an overview of safety for edaravone in ALS patients during the first six cycles of treatment.

Methods: Analysis was based on three randomised, placebo-controlled clinical trials.