Exploratory double-blind, parallel-group, placebo-controlled study of edaravone (MCI-186) in amyotrophic lateral sclerosis (Japan ALS severity classification

Grade 3, requiring assistance for eating, excretion or ambulation)

THE WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 18 STUDY GROUP

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Our objective was to explore the efficacy and safety of edaravone in amyotrophic lateral sclerosis (ALS) patients with a Japan ALS severity classification of Grade 3. In a 24-week, double-blind, randomized study, 25 patients who met all of the following criteria were enrolled: Japan ALS severity classification Grade 3; definite, probable, or probable-laboratory supported ALS (El Escorial/revised Airlie House); forced vital capacity (%FVC) ≥60%; duration of disease ≤3 years at consent; and change in the revised ALS functional rating scale (ALSFRS-R) score of –1 to –4 points during the 12-week pre-observation period. Patients received edaravone (n = 13) or placebo (n = 12) for six cycles. The efficacy outcome was change in the ALSFRS-R score. The least-squares mean change in the ALSFRS-R score ± standard error during the 24-week treatment was –6.52 ± 1.78 in the edaravone group and –6.00 ± 1.83 in the placebo group; the difference of –0.52 ± 2.46 was not statistically significant (p = 0.835). Incidence of adverse events was 92.3% (12/13) in the edaravone group and 100.0% (12/12) in the placebo group. There was no intergroup difference in the changes in the ALSFRS-R score. The incidences of adverse events were similar in the two groups.

Original languageEnglish
Pages (from-to)40-48
Number of pages9
JournalAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration
Volume18
DOIs
Publication statusPublished - Oct 31 2017

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Amyotrophic Lateral Sclerosis
Walking
Japan
Eating
Placebos
Incidence
Vital Capacity
Least-Squares Analysis
Double-Blind Method
Observation
phenylmethylpyrazolone
Safety

Keywords

  • Amyotrophic lateral sclerosis (ALS)
  • edaravone
  • Japan ALS severity classification Grade 3
  • MCI-186
  • revised ALS functional rating scale (ALSFRS-R)

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

@article{85d4ba6b38134c5b93a91cdfcf1d23f6,
title = "Exploratory double-blind, parallel-group, placebo-controlled study of edaravone (MCI-186) in amyotrophic lateral sclerosis (Japan ALS severity classification: Grade 3, requiring assistance for eating, excretion or ambulation)",
abstract = "Our objective was to explore the efficacy and safety of edaravone in amyotrophic lateral sclerosis (ALS) patients with a Japan ALS severity classification of Grade 3. In a 24-week, double-blind, randomized study, 25 patients who met all of the following criteria were enrolled: Japan ALS severity classification Grade 3; definite, probable, or probable-laboratory supported ALS (El Escorial/revised Airlie House); forced vital capacity ({\%}FVC) ≥60{\%}; duration of disease ≤3 years at consent; and change in the revised ALS functional rating scale (ALSFRS-R) score of –1 to –4 points during the 12-week pre-observation period. Patients received edaravone (n = 13) or placebo (n = 12) for six cycles. The efficacy outcome was change in the ALSFRS-R score. The least-squares mean change in the ALSFRS-R score ± standard error during the 24-week treatment was –6.52 ± 1.78 in the edaravone group and –6.00 ± 1.83 in the placebo group; the difference of –0.52 ± 2.46 was not statistically significant (p = 0.835). Incidence of adverse events was 92.3{\%} (12/13) in the edaravone group and 100.0{\%} (12/12) in the placebo group. There was no intergroup difference in the changes in the ALSFRS-R score. The incidences of adverse events were similar in the two groups.",
keywords = "Amyotrophic lateral sclerosis (ALS), edaravone, Japan ALS severity classification Grade 3, MCI-186, revised ALS functional rating scale (ALSFRS-R)",
author = "{THE WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 18 STUDY GROUP} and Koji Abe and Koji Abe and Masashi Aoki and Shoji Tsuji and Gen Sobue and Manabu Doyu and Chikuma Hamada and Shizuki Doi and Katsuhisa Ogata and Kouichi Mizoguchi and Ikuko Aiba and Hidenori Matsuo and Masahiko Tanaka and Makoto Akimoto and Kazue Nakamura and Rie Sumii and Takatomo Yoneoka and Katsuyuki Enjoji and Makiko Yashiro and Fumihiro Takahashi and Tomohisa Iwasaki and Kazuoki Kondo and Hiide Yoshino",
year = "2017",
month = "10",
day = "31",
doi = "10.1080/21678421.2017.1361441",
language = "English",
volume = "18",
pages = "40--48",
journal = "Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration",
issn = "2167-8421",
publisher = "Informa Healthcare",

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T1 - Exploratory double-blind, parallel-group, placebo-controlled study of edaravone (MCI-186) in amyotrophic lateral sclerosis (Japan ALS severity classification

T2 - Grade 3, requiring assistance for eating, excretion or ambulation)

AU - THE WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 18 STUDY GROUP

AU - Abe, Koji

AU - Abe, Koji

AU - Aoki, Masashi

AU - Tsuji, Shoji

AU - Sobue, Gen

AU - Doyu, Manabu

AU - Hamada, Chikuma

AU - Doi, Shizuki

AU - Ogata, Katsuhisa

AU - Mizoguchi, Kouichi

AU - Aiba, Ikuko

AU - Matsuo, Hidenori

AU - Tanaka, Masahiko

AU - Akimoto, Makoto

AU - Nakamura, Kazue

AU - Sumii, Rie

AU - Yoneoka, Takatomo

AU - Enjoji, Katsuyuki

AU - Yashiro, Makiko

AU - Takahashi, Fumihiro

AU - Iwasaki, Tomohisa

AU - Kondo, Kazuoki

AU - Yoshino, Hiide

PY - 2017/10/31

Y1 - 2017/10/31

N2 - Our objective was to explore the efficacy and safety of edaravone in amyotrophic lateral sclerosis (ALS) patients with a Japan ALS severity classification of Grade 3. In a 24-week, double-blind, randomized study, 25 patients who met all of the following criteria were enrolled: Japan ALS severity classification Grade 3; definite, probable, or probable-laboratory supported ALS (El Escorial/revised Airlie House); forced vital capacity (%FVC) ≥60%; duration of disease ≤3 years at consent; and change in the revised ALS functional rating scale (ALSFRS-R) score of –1 to –4 points during the 12-week pre-observation period. Patients received edaravone (n = 13) or placebo (n = 12) for six cycles. The efficacy outcome was change in the ALSFRS-R score. The least-squares mean change in the ALSFRS-R score ± standard error during the 24-week treatment was –6.52 ± 1.78 in the edaravone group and –6.00 ± 1.83 in the placebo group; the difference of –0.52 ± 2.46 was not statistically significant (p = 0.835). Incidence of adverse events was 92.3% (12/13) in the edaravone group and 100.0% (12/12) in the placebo group. There was no intergroup difference in the changes in the ALSFRS-R score. The incidences of adverse events were similar in the two groups.

AB - Our objective was to explore the efficacy and safety of edaravone in amyotrophic lateral sclerosis (ALS) patients with a Japan ALS severity classification of Grade 3. In a 24-week, double-blind, randomized study, 25 patients who met all of the following criteria were enrolled: Japan ALS severity classification Grade 3; definite, probable, or probable-laboratory supported ALS (El Escorial/revised Airlie House); forced vital capacity (%FVC) ≥60%; duration of disease ≤3 years at consent; and change in the revised ALS functional rating scale (ALSFRS-R) score of –1 to –4 points during the 12-week pre-observation period. Patients received edaravone (n = 13) or placebo (n = 12) for six cycles. The efficacy outcome was change in the ALSFRS-R score. The least-squares mean change in the ALSFRS-R score ± standard error during the 24-week treatment was –6.52 ± 1.78 in the edaravone group and –6.00 ± 1.83 in the placebo group; the difference of –0.52 ± 2.46 was not statistically significant (p = 0.835). Incidence of adverse events was 92.3% (12/13) in the edaravone group and 100.0% (12/12) in the placebo group. There was no intergroup difference in the changes in the ALSFRS-R score. The incidences of adverse events were similar in the two groups.

KW - Amyotrophic lateral sclerosis (ALS)

KW - edaravone

KW - Japan ALS severity classification Grade 3

KW - MCI-186

KW - revised ALS functional rating scale (ALSFRS-R)

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