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j.parkreldis.2018.08.024.pdf | 537.8 kB | Adobe PDF | 見る/開く |
タイトル: | Rasagiline monotherapy in early Parkinson's disease: A phase 3, randomized study in Japan |
著者: | Hattori, Nobutaka Takeda, Atsushi Takeda, Shinichi Nishimura, Akira Kitagawa, Tadayuki Mochizuki, Hideki Nagai, Masahiro Takahashi, Ryosuke https://orcid.org/0000-0002-1407-9640 (unconfirmed) |
著者名の別形: | 服部, 信孝 武田, 篤 望月, 秀樹 永井, 将弘 髙橋, 良輔 |
キーワード: | MAO-B inhibitor Rasagiline Japanese Parkinson's disease MDS-UPDRS |
発行日: | Mar-2019 |
出版者: | Elsevier BV |
誌名: | Parkinsonism & Related Disorders |
巻: | 60 |
開始ページ: | 146 |
終了ページ: | 152 |
抄録: | Background: Rasagiline is a monoamine oxidase type-B inhibitor in development in Japan for Parkinson's disease (PD). The objective of this Phase 3, randomized, double-blind study was to evaluate the efficacy and safety of rasagiline in Japanese patients with early PD (NCT02337725). Methods: Patients were 30–79 years old with a diagnosis of PD within 5 years. Following a two-week placebo run-in period, patients were randomized 1:1 to receive rasagiline (1 mg/day) or placebo for up to 26 weeks. The primary endpoint was change from baseline in the MDS-UPDRS Part II + III total score (TS). Secondary endpoints included the MDS-UPDRS Parts II + III, III, II, and I TS and safety. Results: In total, 118 patients were randomized to rasagiline and 126 to placebo. Patient characteristics at baseline were similar in both groups. The change from baseline in the MDS-UPDRS Part II + III TS was significantly greater in the rasagiline vs. placebo group (rasagiline-placebo: −6.39, 95% CI: −8.530, −4.250; P < 0.0001). The mean changes from baseline in the MDS-UPDRS Part II + III, Part III and Part II TS were lower at treatment visits between weeks 6 and 26 in the rasagiline vs. placebo groups. The overall incidence of treatment-emergent adverse events (TEAEs) was 62.4% and 52.4% in the rasagiline and placebo groups, respectively; most frequent TEAE was nasopharyngitis (15.4% and 15.1%). Conclusion: Treatment with oral rasagiline 1 mg/day was effective and well-tolerated in Japanese patients with early PD, with a significantly greater improvement in the MDS-UPDRS Part II + III TS vs. placebo, and a similar safety profile. |
著作権等: | © 2018 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/BY-NC-ND/4.0/). |
URI: | http://hdl.handle.net/2433/242223 |
DOI(出版社版): | 10.1016/j.parkreldis.2018.08.024 |
PubMed ID: | 30205936 |
出現コレクション: | 学術雑誌掲載論文等 |
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