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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Sep 10, 2018
Open Peer Review Period: Sep 11, 2018 - Sep 18, 2018
Date Accepted: Nov 9, 2018
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

The Japanese Early-Stage Trial of High-Dose Methylcobalamin for Amyotrophic Lateral Sclerosis (JETALS): Protocol for a Randomized Controlled Trial

Oki R, Izumi Y, Nodera H, Sato Y, Nokihara H, Kanai K, Sonoo M, Urushitani M, Nishinaka K, Atsuta N, Kohara N, Shimizu T, Kikuchi H, Oda M, Ikeda K, Nagai M, Komai K, Kojima Y, Kuzume D, Isose S, Shimohama S, Abe K, Ito H, Noda K, Ishihara T, Morita M, Shimohata T, Teramukai S, Kagimura T, Noma K, Yanagawa H, Kuwabara S, Kaji R, JETALS

The Japanese Early-Stage Trial of High-Dose Methylcobalamin for Amyotrophic Lateral Sclerosis (JETALS): Protocol for a Randomized Controlled Trial

JMIR Res Protoc 2018;7(12):e12046

DOI: 10.2196/12046

PMID: 30578206

PMCID: 6320396

Japanese Early-Stage Trial of High-Dose Methylcobalamin for Amyotrophic Lateral Sclerosis (JETALS): Protocol of a Prospective, Multicenter, Randomized Phase III Study

  • Ryosuke Oki; 
  • Yuishin Izumi; 
  • Hiroyuki Nodera; 
  • Yasutaka Sato; 
  • Hiroshi Nokihara; 
  • Kazuaki Kanai; 
  • Masahiro Sonoo; 
  • Makoto Urushitani; 
  • Kazuto Nishinaka; 
  • Naoki Atsuta; 
  • Nobuo Kohara; 
  • Toshio Shimizu; 
  • Hitoshi Kikuchi; 
  • Masaya Oda; 
  • Ken Ikeda; 
  • Makiko Nagai; 
  • Kiyonobu Komai; 
  • Yasuhiro Kojima; 
  • Daisuke Kuzume; 
  • Sagiri Isose; 
  • Shun Shimohama; 
  • Koji Abe; 
  • Hidefumi Ito; 
  • Kazuyuki Noda; 
  • Tomohiko Ishihara; 
  • Mitsuya Morita; 
  • Takayoshi Shimohata; 
  • Satoshi Teramukai; 
  • Tatsuo Kagimura; 
  • Kensuke Noma; 
  • Hiroaki Yanagawa; 
  • Satoshi Kuwabara; 
  • Ryuji Kaji; 
  • JETALS

ABSTRACT

Background:

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that affects the upper and lower motor neurons. Currently, only riluzole and edaravone are approved as drugs to treat ALS and new agents with larger effect sizes are warranted. Exploratory analyses in our previous study (study ID No. E0302-J081-761) have suggested that high-dose methylcobalamin (E0302) prolonged the overall survival of ALS patients and suppressed ALS progression in patients with a disease duration of less than 12 months.

Objective:

This clinical trial aims to evaluate the efficacy and safety of E0302 for treatment of ALS patients within one year of onset.

Methods:

The Japanese early-stage trial of high-dose methylcobalamin for ALS (JETALS) is a prospective, multicenter, placebo-controlled, double-blind, randomized phase III study conducted at 24 tertiary neurology centers and is funded by the Japan Agency for Medical Research and Development. A total of 128 ALS patients within one year of onset were randomized at a 1:1 ratio to receive intramuscular injection with E0302 50 mg or placebo twice a week for 16 weeks. The primary endpoint is changes in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score at 16 weeks. If patients wish to receive E0302 50 mg after the double-blind administration period, E0302 will be provided to them until March 2020 during the continuous administration period.

Results:

This study began in October 2017 and is being conducted at 24 participating institutions in Japan. The study is in progress and the patient enrollment period is scheduled to end in August 2019, with follow-up scheduled to end in March 2020.

Conclusions:

This study is being performed to revalidate the efficacy and safety of E0302 in patients with early-stage ALS in the first year of symptom onset. If positive results are obtained, the aim is to apply for E0302 approval as a new drug for the treatment of ALS. Clinical Trial: ClinicalTrials.gov NCT03548311; https://clinicaltrials.gov/ct2/show/NCT03548311 (Archived by WebCite at http://www.webcitation.org/74Fw3rDzb)


 Citation

Please cite as:

Oki R, Izumi Y, Nodera H, Sato Y, Nokihara H, Kanai K, Sonoo M, Urushitani M, Nishinaka K, Atsuta N, Kohara N, Shimizu T, Kikuchi H, Oda M, Ikeda K, Nagai M, Komai K, Kojima Y, Kuzume D, Isose S, Shimohama S, Abe K, Ito H, Noda K, Ishihara T, Morita M, Shimohata T, Teramukai S, Kagimura T, Noma K, Yanagawa H, Kuwabara S, Kaji R, JETALS

The Japanese Early-Stage Trial of High-Dose Methylcobalamin for Amyotrophic Lateral Sclerosis (JETALS): Protocol for a Randomized Controlled Trial

JMIR Res Protoc 2018;7(12):e12046

DOI: 10.2196/12046

PMID: 30578206

PMCID: 6320396

Per the author's request the PDF is not available.

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