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Slowing the loss of physical function in amyotrophic lateral sclerosis with edaravone: Post hoc analysis of ALSFRS-R item scores in pivotal study MCI186-19.

Benjamin Rix BrooksErik P PioroJonathan KatzFumihiro TakahashiKoji TakeiJeffrey ZhangStephen Apple
Published in: Muscle & nerve (2021)
These post-hoc analyses identified the ALSFRS-R item scores and ALSAQ-40 domain scores that were associated with preserved gross motor function and health-related quality of life, respectively, after edaravone treatment. Limitations of post-hoc analyses should be considered when interpreting these results. We recommend that clinical trials employing the ALSFRS-R include this type of analysis as a pre-specified secondary outcome measure.
Keyphrases
  • clinical trial
  • psychometric properties
  • mild cognitive impairment
  • randomized controlled trial
  • phase ii
  • study protocol
  • replacement therapy
  • data analysis