An Exploratory Trial of EPI-589 in Amyotrophic Lateral Sclerosis (EPIC-ALS): Protocol for a Multicenter, Open-Labeled, 24-Week, Single-Group Study

Shotaro Haji   ¹ , MD ;   Koji Fujita   ¹ , MD ;   Ryosuke Oki   ¹ , MD ;   Yusuke Osaki   ¹ , MD ;   Ryosuke Miyamoto   ¹ , MD ;   Hiroyuki Morino   ² , MD ;   Seiichi Nagano   ^{3, 4} , MD ;   Naoki Atsuta   ⁵ , MD ;   Yuki Kanazawa   ⁶ , PhD ;   Yuki Matsumoto   ⁷ , PhD ;   Atsuko Arisawa   ⁸ , MD ;   Hisashi Kawai   ⁹ , MD ;   Yasutaka Sato   ¹⁰ , BSc ;   Satoshi Sakaguchi   ¹⁰ , MD ;   Kenta Yagi   ¹⁰ , PhD ;   Tatsuto Hamatani   ¹¹ , PhD ;   Tatsuo Kagimura   ¹² , PhD ;   Hiroaki Yanagawa   ¹⁰ , MD ;   Hideki Mochizuki   ⁴ , MD ;   Manabu Doyu   ⁵ , MD ;   Gen Sobue   ¹³ , MD ;   Masafumi Harada   ⁷ , MD ;   Yuishin Izumi   ¹ , MD

¹ Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan

² Department of Medical Genetics, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan

³ Department of Neurotherapeutics, Osaka University Graduate School of Medicine, Suita, Japan

⁴ Department of Neurology, Osaka University Graduate School of Medicine, Suita, Japan

⁵ Department of Neurology, Aichi Medical University School of Medicine, Nagakute, Japan

⁶ Department of Biomedical Information Sciences, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan

⁷ Department of Radiology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan

⁸ Department of Diagnostic and Interventional Radiology, Osaka University Graduate School of Medicine, Suita, Japan

⁹ Department of Radiology, Aichi Medical University School of Medicine, Nagakute, Japan

¹⁰ Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan

¹¹ Sumitomo Pharma Co, Ltd, Osaka, Japan

¹² The Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Kobe, Japan

¹³ Aichi Medical University School of Medicine, Nagakute, Japan