JETALS(The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS) is a multicenter, placebo-controlled, double-blind, randomized Phase III clinical trial involving 130 patients with ALS. The study was conducted by a research team consisting of Professor Ryuji Kaji (principal investigator) from the Department of Neurology at the Graduate School of Biomedical Sciences, Tokushima University, Professor Yuishin Izumi (coordinating investigator), and Professor Satoshi Kuwabara (coordinating investigator) from the Department of Neurology at the Graduate School of Medicine, Chiba University.1。
ALSIt is a refractory and progressive neurodegenerative disease that causes severe muscle atrophy and weakness due to motor neuron dysfunction. As the primary cause of death is respiratory failure resulting from respiratory muscle paralysis, patients typically succumb within approximately 2 to 5 years after onset if mechanical ventilation is not utilized.2The number of patients in Japan is estimated to be approximately 10,000.2Currently, there is no treatment for ALS, and the number of drugs approved in Japan and overseas is limited, so the medical needs for this disease have not been met.
Eisai regards neurology as one of its key therapeutic areas. As a "hhcEisai Co., Ltd. (Human Health Care, Caring for Human Health) is committed to further meeting the diverse needs of patients and their families by providing Rozebalamin® as a new treatment option for ALS patients, bringing them greater well-being.
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2. Japan Intractable Diseases Information Center, Amyotrophic lateral sclerosis (ALS), Designated intractable disease (2). https://www.nanbyou.or.jp/entry/52. Last accessed: September 2024. (Japanese only)