期刊
AMYOTROPHIC LATERAL SCLEROSIS AND FRONTOTEMPORAL DEGENERATION
卷 18, 期 -, 页码 55-63出版社
TAYLOR & FRANCIS LTD
DOI: 10.1080/21678421.2017.1364269
关键词
Amyotrophic lateral sclerosis (ALS); edaravone; extension active-treatment period; revised ALS functional rating scale (ALSTRS-R); MCI-186
资金
- Mitsubishi Tanabe Phamia Corporation
- Research on Psychiatric and Neurological Diseases and Mental Health from the Japanese Ministry of Health Labour and Welfare
- NCNP
- Japanese Ministry of Education, Culture, Sports, Science and Technology (MEXT)
- Practical Research Project for Rare/Intractable Diseases from Japan Agency for Medical Research and Development (AMED)
- Eisai Inc.
- Mitsubishi Tanabe Pharma Corporation,
- Astellas Pharma Inc.
- Takeda Pharmaceutical Company Ltd.
- Sanofi Novartis Pharma K.K.
- Dainippon Sumitomo Pharma Co. Ltd.
- Ministry of Education, Culture, Sports, Science and Technology of Japan
- Ministry of Health, Welfare and Labor, Japan
- Japan Agency for Medical Research and Development
- Health and Labour Sciences Research Grant
- Mitsubishi Tanabe Pharma Corporation
- Shionogi Co., Ltd.
- Bristol-Myers Squibb
- Sumitomo Dainippon Pharma Co., Ltd.
- Novartis Pharma KK
- Bayer Yakuhin, Ltd.
- Pfizer Japan Inc.
- Bochringer Ingelhcim 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.
- Ministry of Health, Labor and Welfare Japan
- Japan's Ministry of Education, Culture, Sports, Science and Technology
- Japan Society for the Promotion of Science
- Mitsubishi Tanabe Pharma America, Inc.
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-12], 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 perpendicular to 16.9 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.
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