Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis

THE WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 19 STUDY GROUP

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18 Citations (Scopus)

Abstract

We aimed to explore the longer-term efficacy and safety of edaravone in an active-treatment extension period following the double-blind period of the second phase III study. Patients who met all the following criteria (scores ≥2 points on all 12 items of the revised amyotrophic lateral sclerosis functional rating scale [ALSFRS-R], forced vital capacity ≥80%, definite or probable ALS, and disease duration ≤2 years) were randomised to 60 mg intravenous edaravone or placebo for six cycles in the double-blind period, and then offered the opportunity to proceed to this 24-week open-label extension period. One hundred and twenty-three of 137 patients continued to the extension period: 65 edaravone-edaravone (E-E group) and 58 placebo-edaravone (P-E group). Change (mean ± standard deviation; SD) in the ALSFRS-R score from baseline in the double-blind period was –4.1 ± 3.4 and –6.9 ± 5.1 in the E-E group and P-E group, respectively, while it was –8.0 ± 5.6 in the E-E group and –10.9 ± 6.9 in the P-E group over the whole 48-week period. The ALSFRS-R score changed almost linearly throughout Cycles 1–12 in the E-E group. The most commonly reported adverse events were constipation, dysphagia, and contusion. There was no sudden deterioration in the ALSFRS-R score of the E-E group. No safety concerns related to edaravone were detected.

Original languageEnglish
Pages (from-to)55-63
Number of pages9
JournalAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration
Volume18
DOIs
Publication statusPublished - 31-10-2017

All Science Journal Classification (ASJC) codes

  • Neurology
  • Clinical Neurology

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