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Clinical Trial

Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis

Pages 20-31 | Received 27 Mar 2017, Accepted 26 Jul 2017, Published online: 05 Sep 2017

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (6)

Joseph M. Palumbo, Jean Hubble, Stephen Apple, Koji Takei, Kikumi Tsuda, Shawn Liu, Jeffrey Zhang & Wendy Agnese. (2019) Post-hoc analyses of the edaravone clinical trials Study 16 and Study 19: a step toward more efficient clinical trial designs in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 20:5-6, pages 421-431.
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Hiide Yoshino. (2019) Edaravone for the treatment of amyotrophic lateral sclerosis. Expert Review of Neurotherapeutics 19:3, pages 185-193.
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. (2017) Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18:sup1, pages 55-63.
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Nicholas J. Maragakis. (2017) What can we learn from the edaravone development program for ALS?. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18:sup1, pages 98-103.
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Fumihiro Takahashi, Koji Takei, Kikumi Tsuda & Joseph Palumbo. (2017) Post-hoc analysis of MCI186-17, the extension study to MCI186-16, the confirmatory double-blind, parallel-group, placebo-controlled study of edaravone in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18:sup1, pages 32-39.
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Koji Takei, Kazutoshi Watanabe, Satoshi Yuki, Makoto Akimoto, Takeshi Sakata & Joseph Palumbo. (2017) Edaravone and its clinical development for amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18:sup1, pages 5-10.
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Articles from other publishers (21)

Eleanor Roberts. (2023) A Review of Oral Fixed-Dose Sodium Phenylbutyrate and Ursodoxicoltaurine in People with Amyotrophic Lateral Sclerosis. EMJ Neurology, pages 2-12.
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Hidetoshi Shimizu, Yukiko Nishimura, Youichi Shiide, Makoto Akimoto, Makiko Yashiro, Masaki Ueda, Manabu Hirai, Hiide Yoshino, Tomohiko Mizutani, Kazuaki Kanai, Osamu Kano, Hideki Kimura, Hisakuni Sekino & Kimiko Ito. (2023) Pharmacokinetics of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis. Clinical Therapeutics.
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Katarzyna Ciećwierska, Dorothée Lulé, Maksymilian Bielecki, Olga Helczyk, Anna Maksymowicz-Śliwińska, Julia Finsel, Krzysztof Nieporęcki, Peter M. Andersen, Albert C. Ludolph & Magdalena Kuźma-Kozakiewicz. (2023) Quality of life and depression in patients with amyotrophic lateral sclerosis – does the country of origin matter?. BMC Palliative Care 22:1.
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Angela Genge, Gary L. Pattee, Gen Sobue, Masashi Aoki, Hiide Yoshino, Philippe Couratier, Christian Lunetta, Susanne Petri, Daniel Selness, Sachin Bidani, Manabu Hirai, Takeshi Sakata, Alejandro Salah, Stephen Apple, Art Wamil, Alexander Kalin & Carlayne E. Jackson. (2022) Oral edaravone demonstrated a favorable safety profile in patients with amyotrophic lateral sclerosis after 48 weeks of treatment. Muscle & Nerve 67:2, pages 124-129.
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Shotaro Haji, Koji Fujita, Ryosuke Oki, Yusuke Osaki, Ryosuke Miyamoto, Hiroyuki Morino, Seiichi Nagano, Naoki Atsuta, Yuki Kanazawa, Yuki Matsumoto, Atsuko Arisawa, Hisashi Kawai, Yasutaka Sato, Satoshi Sakaguchi, Kenta Yagi, Tatsuto Hamatani, Tatsuo Kagimura, Hiroaki Yanagawa, Hideki Mochizuki, Manabu Doyu, Gen Sobue, Masafumi Harada & Yuishin Izumi. (2023) An Exploratory Trial of EPI-589 in Amyotrophic Lateral Sclerosis (EPIC-ALS): Protocol for a Multicenter, Open-Labeled, 24-Week, Single-Group Study. JMIR Research Protocols 12, pages e42032.
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Pedro Soares, Catia Silva, Daniel Chavarria, Filomena S.G. Silva, Paulo J. Oliveira & Fernanda Borges. (2023) Drug discovery and amyotrophic lateral sclerosis: Emerging challenges and therapeutic opportunities. Ageing Research Reviews 83, pages 101790.
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Mengxia Gao, Lingqun Zhu, Jingling Chang, Tianyu Cao, Lianying Song, Chunli Wen, Yi Chen, Yudi Zhuo & Fei Chen. (2022) Safety and Efficacy of Edaravone in Patients with Amyotrophic Lateral Sclerosis: A Systematic Review and Meta-analysis. Clinical Drug Investigation 43:1, pages 1-11.
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Fumihiro Takahashi, Osamu Kano, Yoshito Nagano, Takatomo Yoneoka, Sally Nelson & Yoshiteru Ushirogawa. (2022) Associations between the ALSFRS‐R score and urate levels during 12 months of edaravone treatment for amyotrophic lateral sclerosis: Post hoc analysis of ALSFRS‐R scores in clinical studies MCI186 ‐16, MCI186 ‐17, and MCI186 ‐19 . Muscle & Nerve 66:5, pages 593-602.
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Fumihiro Takahashi, Osamu Kano, Yoshito Nagano, Takatomo Yoneoka, Sally Nelson & Yoshiteru Ushirogawa. (2022) Associations between urate levels and amyotrophic lateral sclerosis functional score with edaravone treatment: Post hoc analysis of studies MCI186 ‐16, MCI186 ‐17, and MCI186 ‐19 . Muscle & Nerve 66:5, pages 583-592.
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Teresa Cunha‐Oliveira, Daniela Franco Silva, Luis Segura, Inês Baldeiras, Ricardo Marques, Tatiana Rosenstock, Paulo J. Oliveira & Filomena S. G. Silva. (2022) Redox profiles of amyotrophic lateral sclerosis lymphoblasts with or without known SOD1 mutations. European Journal of Clinical Investigation 52:9.
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Anca Motataianu, Georgiana Serban, Laura Barcutean & Rodica Balasa. (2022) Oxidative Stress in Amyotrophic Lateral Sclerosis: Synergy of Genetic and Environmental Factors. International Journal of Molecular Sciences 23:16, pages 9339.
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Myrsini Chamakioti, Nikolaos Karantzelis & Stavros Taraviras. (2022) Advanced Gene-Targeting Therapies for Motor Neuron Diseases and Muscular Dystrophies. International Journal of Molecular Sciences 23:9, pages 4824.
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C. Quarracino, M. Bendersky, R. Rey & G. E. Rodríguez. (2020) Logistics and safety of edaravone treatment for amyotrophic lateral sclerosis: experience in Argentina. Acta Neurologica Belgica 121:6, pages 1519-1523.
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Hidetoshi Shimizu, Yukiko Nishimura, Youichi Shiide, Kaori Yoshida, Manabu Hirai, Munetomo Matsuda, Yoshinobu Nakamaru, Yuichiro Kato & Kazuoki Kondo. (2021) Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects. Clinical Pharmacology in Drug Development 10:10, pages 1188-1197.
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Hidetoshi Shimizu, Yukiko Nishimura, Yoichi Shiide, Hideaki Matsuda, Makoto Akimoto, Munetomo Matsuda, Yoshinobu Nakamaru, Yuichiro Kato & Kazuoki Kondo. (2021) Evaluation of Pharmacokinetics, Safety, and Drug‐Drug Interactions of an Oral Suspension of Edaravone in Healthy Adults. Clinical Pharmacology in Drug Development 10:10, pages 1174-1187.
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Kaoru Ishizaki, Kenta Yoshimura, Kengo Yoshida, Masao Matsuda, Yutaka Kawaguchi, Satoshi Yuki & Gen Sobue. (2021) Real‐world safety of the novel, free radical scavenger edaravone for amyotrophic lateral sclerosis patients: Data from the post‐marketing surveillance SUNRISE Japan. Neurology and Clinical Neuroscience 9:3, pages 223-229.
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Hidetoshi Shimizu, Shinsuke Inoue, Mai Endo, Yoshinobu Nakamaru, Kaori Yoshida, Tomoko Natori, Masae Kakubari, Makoto Akimoto & Kazuoki Kondo. (2020) A Randomized, Single‐Blind, Placebo‐Controlled, 3‐Way Crossover Study to Evaluate the Effect of Therapeutic and Supratherapeutic Doses of Edaravone on QT/QTc Interval in Healthy Subjects. Clinical Pharmacology in Drug Development 10:1, pages 46-56.
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Juan Fernando Ortiz, Sawleha Arshi Khan, Amr Salem, Zayar Lin, Zafar Iqbal & Nusrat Jahan. (2020) Post-Marketing Experience of Edaravone in Amyotrophic Lateral Sclerosis: A Clinical Perspective and Comparison With the Clinical Trials of the Drug. Cureus.
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I Nyoman Semadi, Kelvin Setiawan & Hendry Irawan. (2020) Clinical profile and laboratory finding of diabetic foot ulcers from tertiary hospitals in Bali. Polish Annals of Medicine.
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Manoj Kumar Jaiswal. (2018) Riluzole and edaravone: A tale of two amyotrophic lateral sclerosis drugs. Medicinal Research Reviews 39:2, pages 733-748.
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Said R Beydoun & Jeffrey Rosenfeld. (2018) Edaravone in Amyotrophic Lateral Sclerosis’Lessons from the Clinical Development Program and the Importance of a Strategic Clinical Trial Design. US Neurology 14:1, pages 47.
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