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JETALS: The Japanese Early-stage Trial of high dose methylcobalamin for ALS Yuishin Izumi 1 , Ryosuke Oki 1 , Satoshi Kuwabara 2 , Ryuji Kaji 3,4 1Department of Neurology, Tokushima University Hospital 2Department of Neurology, Graduate School of Medicine, Chiba University 3Department of Clinical Neuroscience, Institute of Biomedical Science, Tokushima University Graduate School 4Department of Neurology, National Hospital Organization Utano National Hospital Keyword: 筋萎縮性側索硬化症 , メコバラミン , ビタミンB12 , 治験 , JETALS , amyotrophic lateral sclerosis , methylcobalamin , vitamin B12 , clinical trial pp.1261-1269
Published Date 2019/11/1
DOI https://doi.org/10.11477/mf.1416201436
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Abstract

High-dose methylcobalamin was found to be a therapeutic candidate for amyotrophic lateral sclerosis (ALS) through clinical experience. Our previous study (E0302-J081-761) has suggested that high-dose methylcobalamin (E0302) prolonged the overall survival and suppressed progression in ALS patients with a disease duration less than 12 months in, exploratory analyses. Therefore, we plan to conduct an investigator-initiated trial “The Japan Early-stage Trial of high dose methylcobalamin for ALS (JETALS)” to evaluate the efficacy and safety of E0302 for ALS patients within 12 months from onset. JETALS is a prospective, multicenter, placebo-controlled, double-blind, randomized Phase III study, conducted at 25 tertiary neurology centers, and is funded by the Japan Agency for Medical Research and Development. A total of 128 patients 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 (ALSFRS-R) total score at 16 weeks. The patient enrollment period is from November 2017 to September 2019, and the follow-up is scheduled to end in March 2020. If the results are positive, we intend to apply for E0302 approval for methylcobalamin as a new drug for treating ALS.


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