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Research Articles

Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients

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Pages 610-617 | Received 12 Dec 2013, Accepted 24 Aug 2014, Published online: 06 Oct 2014

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Asef Azad, Ümmü Rana Gökmen, Hilmi Uysal, Sadi Köksoy, Uğur Bilge & Ayşe Esra Manguoğlu. (2023) Autophagy dysregulation plays a crucial role in regulatory T-cell loss and neuroinflammation in amyotrophic lateral sclerosis (ALS). Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 0:0, pages 1-9.
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Gary L. Pattee, Angela Genge, Philippe Couratier, Christian Lunetta, Gen Sobue, Masashi Aoki, Hiide Yoshino, Carlayne E. Jackson, James Wymer, Alejandro Salah & Sally Nelson. (2023) Oral Edaravone – Introducing a Flexible Treatment Option for Amyotrophic Lateral Sclerosis. Expert Review of Neurotherapeutics 0:0, pages 1-8.
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Jeremy M. Shefner, Ammar Al-Chalabi, Jinsy A. Andrews, Adriano Chio, Mamede De Carvalho, Bettina M. Cockroft, Philippe Corcia, Philippe Couratier, Merit E. Cudkowicz, Angela Genge, Orla Hardiman, Terry Heiman-Patterson, Robert D. Henderson, Caroline Ingre, Carlayne E. Jackson, Wendy Johnston, Noah Lechtzin, Albert Ludolph, Nicholas J. Maragakis, Timothy M. Miller, Jesus S. Mora Pardina, Susanne Petri, Zachary Simmons, Leonard H. Van Den Berg, Lorne Zinman, Stuart Kupfer, Fady I. Malik, Lisa Meng, Tyrell J. Simkins, Jenny Wei, Andrew A. Wolff & Stacy A. Rudnicki. (2023) COURAGE-ALS: a randomized, double-blind phase 3 study designed to improve participant experience and increase the probability of success. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 24:5-6, pages 523-534.
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Hee Jo Han, Ha Young Shin, Young-Chul Choi, Seung Min Kim & Seung Woo Kim. (2022) Serum uric acid level predicts the progression of amyotrophic lateral sclerosis following treatment with edaravone. Redox Report 27:1, pages 79-84.
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Benjamin Rix Brooks, Erik P. Pioro, Danielle Beaulieu, Albert A. Taylor, Mark Schactman, Mike Keymer, Wendy Agnese, Johnna Perdrizet, Stephen Apple & David L. Ennist. (2022) Evidence for generalizability of edaravone efficacy using a novel machine learning risk-based subgroup analysis tool. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 23:1-2, pages 49-57.
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Pamela A. McCombe, Fleur C Garton, Matthew Katz, Naomi R Wray & Robert D Henderson. (2020) What do we know about the variability in survival of patients with amyotrophic lateral sclerosis?. Expert Review of Neurotherapeutics 20:9, pages 921-941.
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R Hergesheimer, D Lanznaster, P Vourc’h, Cr Andres, Se Bakkouche, S Beltran, H Blasco, P Corcia & P Couratier. (2020) Advances in disease-modifying pharmacotherapies for the treatment of amyotrophic lateral sclerosis. Expert Opinion on Pharmacotherapy 21:9, pages 1103-1110.
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Andrea Barp, Francesca Gerardi, Andrea Lizio, Valeria Ada Sansone & Christian Lunetta. (2020) Emerging Drugs for the Treatment of Amyotrophic Lateral Sclerosis: A Focus on Recent Phase 2 Trials. Expert Opinion on Emerging Drugs 25:2, pages 145-164.
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Nathalie Braun, Eric A. Macklin, Ervin Sinani, Alexander Sherman & Markus Weber. (2020) The revised El Escorial criteria “clinically probable laboratory supported ALS”—once a promising now a superfluous category?. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 21:1-2, pages 24-28.
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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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Alon Abraham, Beatrice Nefussy, Yaara Fainmesser, Yoram Ebrahimi, Arnon Karni & Vivian E. Drory. (2019) Early post-marketing experience with edaravone in an unselected group of patients with ALS. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 20:3-4, pages 260-263.
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Francesca Palese, Arianna Sartori, Giancarlo Logroscino & Federica Edith Pisa. (2019) Predictors of diagnostic delay in amyotrophic lateral sclerosis: a cohort study based on administrative and electronic medical records data. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 20:3-4, pages 176-185.
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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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. (2018) Theme 13 Clinical management and support. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 19:sup1, pages 353-374.
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John Turnbull. (2018) Is edaravone harmful? (A placebo is not a control). Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 19:7-8, pages 477-482.
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Nimish J. Thakore, Brittany R. Lapin, Tyler G. Kinzy & Erik P. Pioro. (2018) Deconstructing progression of amyotrophic lateral sclerosis in stages: a Markov modeling approach. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 19:7-8, pages 483-494.
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Marion C. Hogg, Luise Halang, Ina Woods, Karen S. Coughlan & Jochen H. M. PREHN. (2018) Riluzole does not improve lifespan or motor function in three ALS mouse models. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 19:5-6, pages 438-445.
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Crystal Jing Jing Yeo & Zachary Simmons. (2018) Discussing edaravone with the ALS patient: an ethical framework from a U.S. perspective. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 19:3-4, pages 167-172.
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Carmel Armon. (2018) Ethics of clinical research in patients with ALS: is there a risk of exploitation?. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 19:3-4, pages 161-166.
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Shyuan T Ngo, Jia D Mi, Robert D Henderson, Pamela A McCombe & Frederik J Steyn. (2017) Exploring targets and therapies for amyotrophic lateral sclerosis: current insights into dietary interventions. Degenerative Neurological and Neuromuscular Disease 7, pages 95-108.
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Koji Takei, Kikumi Tsuda, Fumihiro Takahashi & Joseph Palumbo. (2017) Post-hoc analysis of open-label extension period of study MCI186-19 in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18:sup1, pages 64-70.
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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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Alexander Kalin, Elvia Medina-Paraiso, Kaoru Ishizaki, Alex Kim, Yannong Zhang, Takanori Saita & Masahiko Wasaki. (2017) A safety analysis of edaravone (MCI-186) during the first six cycles (24 weeks) of amyotrophic lateral sclerosis (ALS) therapy from the double-blind period in three randomized, placebo-controlled studies. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18:sup1, pages 71-79.
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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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Koji Takei, Kikumi Tsuda, Fumihiro Takahashi, Manabu Hirai & Joseph Palumbo. (2017) An assessment of treatment guidelines, clinical practices, demographics, and progression of disease among patients with amyotrophic lateral sclerosis in Japan, the United States, and Europe. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18:sup1, pages 88-97.
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Koji Takei, Fumihiro Takahashi, Shawn Liu, Kikumi Tsuda & Joseph Palumbo. (2017) Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18:sup1, pages 49-54.
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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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Yoshinobu Nakamaru, Shuji Kinoshita, Atsuhiro Kawaguchi, Koji Takei, Joseph Palumbo & Masayuki Suzuki. (2017) Pharmacokinetic profile of edaravone: a comparison between Japanese and Caucasian populations. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18:sup1, pages 80-87.
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Bello Hamidou, Benoit Marin, Geraldine Lautrette, Marie Nicol, William Camu, Philippe Corcia, Marie-Christine Arnes-Bes, Christine Tranchant, Pierre Clavelou, Didier Hannequin, Giroud Maurice, Katell Beauvais, Jean-Christophe Antoine, Véronique Danel-Brunaud, Fausto Viader, Pierre-Marie Preux & Philippe Couratier. (2017) Exploring the diagnosis delay and ALS functional impairment at diagnosis as relevant criteria for clinical trial enrolment*. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18:7-8, pages 519-527.
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Hideyuki Sawada. (2017) Clinical efficacy of edaravone for the treatment of amyotrophic lateral sclerosis. Expert Opinion on Pharmacotherapy 18:7, pages 735-738.
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Yu-ichi Noto, Kazumoto Shibuya, Steve Vucic & Matthew C. Kiernan. (2016) Novel therapies in development that inhibit motor neuron hyperexcitability in amyotrophic lateral sclerosis. Expert Review of Neurotherapeutics 16:10, pages 1147-1154.
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Rebecca Traub & Hiroshi Mitsumoto. (2016) Recent advances and opportunities for improving diagnosis of amyotrophic lateral sclerosis. Expert Opinion on Orphan Drugs 4:9, pages 907-915.
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H Blasco, F Patin, CR Andres, P Corcia & PH Gordon. (2016) Amyotrophic Lateral Sclerosis, 2016: existing therapies and the ongoing search for neuroprotection. Expert Opinion on Pharmacotherapy 17:12, pages 1669-1682.
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Verena C Haringer & Summer B Gibson. (2015) Amyotrophic lateral sclerosis: clinical perspectives. Orphan Drugs: Research and Reviews 5, pages 19-31.
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Kazumoto Shibuya, Sonoko Misawa, Hideki Kimura, Yu-Ichi Noto, Yasunori Sato, Yukari Sekiguchi, Yuta Iwai, Satsuki Mitsuma, Minako Beppu, Keisuke Watanabe, Yumi Fujimaki, Yukiko Tsuji, Toshio Shimizu, Toshiki Mizuno, Masanori Nakagawa, Kyoko Sawaguchi, Hideki Hanaoka & Satoshi Kuwabara. (2015) A single blind randomized controlled clinical trial of mexiletine in amyotrophic lateral sclerosis: Efficacy and safety of sodium channel blocker phase II trial. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 16:5-6, pages 353-358.
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Sabina Antonela Antoniu. (2015) Fresh from the designation pipeline: orphan drugs designated in the European Union (November – December 2014). Expert Opinion on Orphan Drugs 3:6, pages 719-725.
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Muzammil Arif Din Abdul Jabbar, Ling Guo, Sonakshi Nag, Yang Guo, Zachary Simmons, Erik P. Pioro, Savitha Ramasamy & Crystal Jing Jing Yeo. Predicting amyotrophic lateral sclerosis (ALS) progression with machine learning. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 0:0, pages 1-14.
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