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

Ryosuke Oki   ¹ , MD ;   Yuishin Izumi   ¹ , MD, PhD ;   Hiroyuki Nodera   ¹ , MD, PhD ;   Yasutaka Sato   ² , MBBS ;   Hiroshi Nokihara   ² , MD, PhD ;   Kazuaki Kanai   ³ , MD, PhD ;   Masahiro Sonoo   ⁴ , MD, PhD ;   Makoto Urushitani   ⁵ , MD, PhD ;   Kazuto Nishinaka   ⁶ , MD, ;   Naoki Atsuta   ⁷ , MD, PhD ;   Nobuo Kohara   ⁸ , MD, PhD ;   Toshio Shimizu   ⁹ , MD, PhD ;   Hitoshi Kikuchi   ¹⁰ , MD, PhD ;   Masaya Oda   ¹¹ , MD, PhD ;   Ken Ikeda   ¹² , MD, PhD ;   Makiko Nagai   ¹³ , MD, PhD ;   Kiyonobu Komai   ¹⁴ , MD, PhD ;   Yasuhiro Kojima   ¹⁵ , MD ;   Daisuke Kuzume   ¹⁶ , MD ;   Sagiri Isose   ¹⁷ , MD, PhD ;   Shun Shimohama   ¹⁸ , MD, PhD ;   Koji Abe   ¹⁹ , MD, PhD ;   Hidefumi Ito   ²⁰ , MD, PhD ;   Kazuyuki Noda   ²¹ , MD, PhD ;   Tomohiko Ishihara   ²² , MD, PhD ;   Mitsuya Morita   ²³ , MD, PhD ;   Takayoshi Shimohata   ²⁴ , MD, PhD ;   Satoshi Teramukai   ²⁵ , PhD ;   Tatsuo Kagimura   ²⁶ , PhD ;   Kensuke Noma   ^{27, 28} , MD, PhD ;   Hiroaki Yanagawa   ² , MD, PhD ;   Satoshi Kuwabara   ²⁹ , MD, PhD ;   Ryuji Kaji   ¹ , MD, PhD ;   JETALS   ¹

¹ Department of Clinical Neuroscience, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan

² Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan

³ Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan

⁴ Department of Neurology, Teikyo University School of Medicine, Tokyo, Japan

⁵ Department of Neurology, Shiga University of Medical Science, Otsu, Japan

⁶ Department of Neurology, Sumitomo Hospital, Osaka, Japan

⁷ Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan

⁸ Department of Neurology, Kobe City Medical Centre General Hospital, Kobe, Japan

⁹ Department of Neurology, Tokyo Metropolitan Neurological Hospital, Tokyo, Japan

¹⁰ Department of Neurology, Murakami Karindo Hospital, Fukuoka, Japan

¹¹ Department of Neurology, Vihara Hananosato Hospital, Miyoshi, Japan

¹² Department of Neurology, Toho University Omori Medical Center, Tokyo, Japan

¹³ Department of Neurology, Kitasato University East Hospital, Sagamihara, Japan

¹⁴ Department of Neurology, National Hospital Organization Iou Hospital, Kanazawa, Japan

¹⁵ Department of Neurology, Takeda General Hospital, Kyoto, Japan

¹⁶ Department of Neurology, Chikamori Hospital, Kochi, Japan

¹⁷ Department of Neurology, National Hospital Organization Chiba-East Hospital, Chiba, Japan

¹⁸ Department of Neurology, Sapporo Medical University, Sapporo, Japan

¹⁹ Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan

²⁰ Department of Neurology, Wakayama Medical University, Wakayama, Japan

²¹ Department of Neurology, Juntendo University Shizuoka Hospital, Izunokuni, Japan

²² Department of Neurology, Brain Research Institute, Niigata University, Niigata, Japan

²³ Division of Neurology, Department of Internal Medicine, Jichi Medical University, Tochigi, Japan

²⁴ Department of Neurology and Geriatrics, Gifu University Graduate School of Medicine, Gifu, Japan

²⁵ Department of Biostatistics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan

²⁶ Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation, Kobe, Japan

²⁷ Division of Regeneration and Medicine, Medical Center for Translational and Clinical Research, Hiroshima University Hospital, Hiroshima, Japan

²⁸ Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan

²⁹ Department of Neurology, Graduate School of Medicine, Chiba University, Chiba, Japan