Clinical staging in amyotrophic lateral sclerosis: analysis of Edaravone Study 19.

ABSTRACT:

Objective

This was a post hoc analysis of the Edaravone Phase III Study MCI186-19 ('Study 19') to examine the utility of clinical staging systems as end points in clinical trials in amyotrophic lateral sclerosis (ALS).

Methods

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised item scores from Study 19 were retrospectively mapped to King's stage and Milano-Torino staging (MiToS) stage. We assessed the percentage of patients who experienced progression in King's and MiToS stages during Study 19. We also assessed disease progression in subgroups of patients according to baseline King's stage.

Results

During double-blind treatment, the percentage of patients who experienced a progression in King's stage was lower for edaravone (42.0%, 95% CI 30.4% to 53.6%) th

SUBMITTER: Al-Chalabi A 

PROVIDER: S-EPMC7841496 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature