@article{6423af45ac594178b747232bc3adff2d,
title = "Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis",
abstract = "Following the first phase III study of edaravone for amyotrophic lateral sclerosis (ALS), this extension study was performed to evaluate longer-term efficacy and safety. Patients given edaravone in the first 24-week phase III study (Cycles 1–6) were randomised to edaravone (E-E) or placebo (E-P) in the subsequent 24-week double-blind period (Cycles 7–12). Patients given placebo in phase III were switched to edaravone (P-E). Subsequently, all patients received edaravone for 12 weeks (Cycles 13–15). Efficacy endpoints included revised ALS Functional Rating Scale (ALSFRS-R) score. Analysis populations were the full analysis set (FAS) and the efficacy-expected subpopulation (EESP) defined by post-hoc analysis of the first phase III study. The least-squares mean and standard error of the intergroup difference (E-E vs. E-P) of change in the ALSFRS-R score from Cycles 7–12 was 1.16 ± 0.93 (p = 0.2176) in the FAS, and 1.85 ± 1.14 (p = 0.1127) in the EESP. The ALSFRS-R score changed almost linearly in the E-E group throughout Cycles 1–15 (60 weeks). The incidence of serious adverse events associated with ALS progression was higher in E-E than in E-P. Edaravone might have potential efficacy for up to 15 cycles when used to treat patients in the EESP with careful safety monitoring.",
keywords = "Amyotrophic lateral sclerosis (ALS), MCI-186, edaravone, extension study, revised ALS functional rating scale (ALSFRS-R)",
author = "{THE WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 17 STUDY GROUP} and Koji Abe and Yasuto Itoyama and Shoji Tsuji and Gen Sobue and Masashi Aoki and Manabu Doyu and Chikuma Hamada and Hidenao Sasaki and Asako Takei and Isao Yamashita and Takashi Imai and Imaharu Nakanoyy and Koichi Okamoto and Yuichi Maruki and Shuichi Mishima and Jin Nishimiya and Yasuo Iwasaki and Mineo Yamazaki and Yuji Takahashi and Mieko Ogino and Yutaka Ogino and Masafumi Ogawa and Tetsumasa Kamei and Tsuyoshi Uchiyama and Hirohisa Watanabe and Yasumasa Kokubo and Hideyuki Sawada and Takanori Hazama and Fumiharu Kimura and Harutoshi Fujimura and Hirofumi Kusaka and Tsukasa Hashimoto and Takeshi Yamada and Yuji Kanamori and Kenji Yamasaki and Shizuma Kaku and Hitoshi Kikuchi and Shigehiro Imamura and Seiichiro Sugimoto and Masahiko Kishi and Masahiko Tanaka and Makoto Akimoto and Kazue Nakamura and Hiroshi Naito and Aiko Murakami and Hajime Sakamoto and Takatomo Yoneoka and Katsuyuki Enjoji and Junko Ogawa and Kiyoe Yano",
note = "Publisher Copyright: {\textcopyright} 2017 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.",
year = "2017",
month = oct,
day = "31",
doi = "10.1080/21678421.2017.1362000",
language = "English",
volume = "18",
pages = "20--31",
journal = "Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration",
issn = "2167-8421",
publisher = "Informa Healthcare",
}