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 language | English (US) |
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Pages (from-to) | 218-221 |
Number of pages | 4 |
Journal | Muscle and Nerve |
Volume | 61 |
Issue number | 2 |
DOIs | |
State | Published - Feb 1 2020 |
Keywords
- ALSFRS-R
- chronic
- disease progression
- functional decline
- linear regression
- oxidative stress
ASJC Scopus subject areas
- Clinical Neurology
- Physiology (medical)
- Cellular and Molecular Neuroscience
- Physiology