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Abstract
We aimed to explore the longer-term efficacy and safety of edaravone in an active-treatment extension period following the double-blind period of the second phase III study. Patients who met all the following criteria (scores ≥2 points on all 12 items of the revised amyotrophic lateral sclerosis functional rating scale [ALSFRS-R], forced vital capacity ≥80%, definite or probable ALS, and disease duration ≤2 years) were randomised to 60 mg intravenous edaravone or placebo for six cycles in the double-blind period, and then offered the opportunity to proceed to this 24-week open-label extension period. One hundred and twenty-three of 137 patients continued to the extension period: 65 edaravone-edaravone (E-E group) and 58 placebo-edaravone (P-E group). Change (mean ± standard deviation; SD) in the ALSFRS-R score from baseline in the double-blind period was –4.1 ± 3.4 and –6.9 ± 5.1 in the E-E group and P-E group, respectively, while it was –8.0 ± 5.6 in the E-E group and –10.9 ± 6.9 in the P-E group over the whole 48-week period. The ALSFRS-R score changed almost linearly throughout Cycles 1–12 in the E-E group. The most commonly reported adverse events were constipation, dysphagia, and contusion. There was no sudden deterioration in the ALSFRS-R score of the E-E group. No safety concerns related to edaravone were detected.
Acknowledgements
We thank all participating patients and their family members and the Data Safety Monitoring Committee (Manabu Doyu, Department of Neurology, Aichi Medical University Hospital, Aichi; Fumio Kanda, Integrated Clinical Education Center, Kobe University Hospital, Kobe; Toshimitsu Hamasaki, Osaka University, Graduate School of Medicine, Osaka (present affiliation is National Cerebral and Cardiovascular Center, Osaka); participating staff at all study sites; Teresa Oblak of Covance Market Access, Inc., for editorial assistance; Aya Tokaji and Marika Ogasawara of MDS-CMG Inc., for publication assistance; Richard Steele of WRS Steele Scientific and Technical Editing for proofreading the manuscript; Koji Takei and Kikumi Tsuda of Mitsubishi Tanabe Pharma Development America for critical review of the manuscript.
Declaration of interests
Mr. Abe reports personal fees from Mitsubishi Tanabe Pharma Corporation unrelated to the submitted work. Mr. Aoki reports grants from Research on Psychiatric and Neurological Diseases and Mental Health from the Japanese Ministry of Health Labour and Welfare, Grants-in-Aid for Scientific Research, grants from An Intramural Research Grant for Neurological Psychiatric Disorders from NCNP, grants from Grants-in-Aids for Scientific Research from the Japanese Ministry of Education, Culture, Sports, Science and Technology (MEXT), grants from Practical Research Project for Rare/Intractable Diseases from Japan Agency for Medical Research and Development (AMED), personal fees from Eisai Inc., Mitsubishi Tanabe Pharma Corporation, Astellas Pharma Inc., Takeda Pharmaceutical Company Ltd., Sanofi K.K., Novartis Pharma K.K., and Dainippon Sumitomo Pharma Co. Ltd., unrelated to the submitted work. Mr. Tsuji reports grants from the Ministry of Education, Culture, Sports, Science and Technology of Japan, grants from Ministry of Health, Welfare and Labor, Japan, grants from Japan Agency for Medical Research and Development, and personal fees from Mitsubishi Tanabe Pharma Corporation unrelated to the submitted work. Mr. Itoyama reports grants from Health and Labour Sciences Research Grant and personal fees from Mitsubishi Tanabe Pharma Corporation unrelated to the submitted work. Mr. Sobue reports personal fees from Mitsubishi Tanabe Pharma Corporation, Shionogi & Co., Ltd., Bristol-Myers Squibb, Sumitomo Dainippon Pharma Co., Ltd., Novartis Pharma KK, Bayer Yakuhin, Ltd., Pfizer Japan Inc., Boehringer Ingelheim Japan, Inc., Kissei Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Teijin Pharma Ltd., FP Pharmaceutical Corporation, Nihon Pharmaceutical Co., Ltd., Japan Blood Products Organisation, Kowa Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Eisai Co., Ltd., as well as grants from Grants-in-Aid from the Ministry of Health, Labor and Welfare Japan, grants from Grant-in-Aid, Japan's Ministry of Education, Culture, Sports, Science and Technology, grants from Grant-in-Aid for Scientific Research, and the Japan Society for the Promotion of Science, unrelated to the submitted work. Mr. Hamada reports personal fees from Mitsubishi Tanabe Pharma Corporation unrelated to the submitted work. Mr. Togo, Mr. Tanaka, Mr. Akimoto, Ms. Nakamura, Mr. Ueda, Mr. Takahashi and Mr. Kondo report personal fees from Mitsubishi Tanabe Pharma Corporation during the conduct of the study as well as personal fees from Mitsubishi Tanabe Pharma Corporation unrelated to the submitted work. Mr. Yoshino reports personal fees from Mitsubishi Tanabe Pharma Corporation with whom he had co-owned a patent unrelated to the submitted work.
The study was funded by Mitsubishi Tanabe Pharma Corporation.
Open access publication of this article and editorial support were funded by Mitsubishi Tanabe Pharma America, Inc.