Long-term edaravone efficacy in amyotrophic lateral sclerosis: Post-hoc analyses of Study 19 (MCI186-19)

Jeremy Shefner, Terry Heiman-Patterson, Erik P. Pioro, Martina Wiedau-Pazos, Shawn Liu, Jeffrey Zhang, Wendy Agnese, Stephen Apple*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

25 Scopus citations

Abstract

Background: In a Phase 3 study, amyotrophic lateral sclerosis (ALS) patients experienced significantly less physical functional decline with 24-week edaravone vs placebo, followed by open-label treatment for an additional 24 weeks. Methods: Outcome (the change in ALS Functional Rating Scale–Revised, ALSFRS-R, from baseline) was projected for placebo patients through 48 weeks and compared with 48-week edaravone or 24-week edaravone after switching from placebo. Results: A total of 123 patients received open-label treatment (65 edaravone-edaravone; 58 placebo-edaravone). The projected ALSFRS-R decline for placebo from baseline through week 48 was greater than for 48-week edaravone (P <.0001). For patients switching from placebo to edaravone, ALSFRS-R slope approached that of continued edaravone for 48 weeks. ALSFRS-R decline did not differ between actual and projected edaravone through week 48. Conclusions: Compared with placebo, these analyses suggest that edaravone is beneficial in ALS patients even after 6 mo of receiving placebo, and efficacy is maintained for up to 1 year.

Original languageEnglish (US)
Pages (from-to)218-221
Number of pages4
JournalMuscle and Nerve
Volume61
Issue number2
DOIs
StatePublished - Feb 1 2020
Externally publishedYes

Keywords

  • ALSFRS-R
  • chronic
  • disease progression
  • functional decline
  • linear regression
  • oxidative stress

ASJC Scopus subject areas

  • Physiology
  • Clinical Neurology
  • Cellular and Molecular Neuroscience
  • Physiology (medical)

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