Advanced search
Publication Cover
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration Volume 18, 2017 - Issue sup1: Edaravone (MCI-186) in Amyotrophic Lateral Sclerosis (ALS). Guest Editor: Angela Genge
Submit an article Journal homepage
3,930
Views
21
CrossRef citations to date
0
Altmetric
Research Article

Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis

Koji TakeiMitsubishi Tanabe Pharma Development America, Inc, Jersey City, NJ, USA, and Correspondence[email protected]
,
Fumihiro TakahashiMitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan
,
Shawn LiuMitsubishi Tanabe Pharma Development America, Inc, Jersey City, NJ, USA, and
,
Kikumi TsudaMitsubishi Tanabe Pharma Development America, Inc, Jersey City, NJ, USA, and
&
Joseph PalumboMitsubishi Tanabe Pharma Development America, Inc, Jersey City, NJ, USA, and ;Mitsubishi Tanabe Pharma Corporation, Chuo-ku, Tokyo, Japan
Pages 49-54 | Received 01 May 2017, Accepted 19 Jul 2017, Published online: 05 Sep 2017

References

  • Abe K, Itoyama Y, Sobue G, Tsuji S, Aoki M, Doyu M, et al. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014;15:610–7.
  • The Edaravone (MCI-186) ALS 16 Study Group. A post-hoc subgroup analysis of outcomes in the first phase 3 clinical study of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18 (suppl. 1). Epub ahead of print. doi: 10.1080/21678421.2017.1363780.
  • The Writing Group on behalf of the Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well-defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16:505–12.
  • Berry JD, Miller R, Moore DH, Cudkowicz ME, van den Berg LH, Kerr DA, et al. The Combined Assessment of Function and Survival (CAFS): a new endpoint for ALS clinical trials. Amyotroph Lateral Scler Frontotemporal Degener. 2013;14:162–8.
  • Bacci ED, Staniewska D, Coyne KS, Boyer S, White LA, Zach N, Pooled Resource Open-Access ALS Clinical Trials Consortium, et al. Item response theory analysis of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised in the Pooled Resource Open-Access ALS Clinical Trials Database. Amyotroph Lateral Scler Frontotemporal Degener. 2016;17:157–67.
  • Rooney J, Burke T, Vajda A, Heverin M, Hardiman O. What does the ALSFRS-R really measure? A longitudinal and survival analysis of functional dimension subscores in amyotrophic lateral sclerosis. J Neurol Neurosurg Psychiatry. 2017;88:381–5.
  • Cudkowicz ME, van den Berg LH, Shefner JM, Mitsumoto H, Mora JS, Ludolph A, et al. Dexpramipexole versus placebo for patients with amyotrophic lateral sclerosis (EMPOWER): a randomised, double-blind, phase 3 trial. Lancet Neurol. 2013;12:1059–67.
  • Committee for Medicinal Products for Human Use (CHMP). Guideline on Missing Data in Confirmatory Clinical Trials. EMA/CPMP/EWP/1776/99 Rev. 1. 2010.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.