Transdermal rotigotine in early stage Parkinson's disease: A randomized, double‐blind, placebo‐controlled trial
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- Yoshikuni Mizuno
- Department of Neuroregeneration Kitasato University School of Medicine Sagamihara Japan
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- Masahiro Nomoto
- Department of Neurology Ehime University School of Medicine Matsuyama Japan
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- Tomoyoshi Kondo
- Department of Neurology Wakayama Medical University Wakayama Japan
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- Kazuko Hasegawa
- Department of Neurology National Hospital Organization, Sagamihara National Hospital Sagamihara Japan
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- Miho Murata
- Department of Neurology National Center Hospital, National Center of Neurology and Psychiatry Tokyo Japan
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- Masahiro Takeuchi
- Department of Biostatistics Kitasato University School of Pharmacy Tokyo Japan
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- Junji Ikeda
- Otsuka Pharmaceutical Company, Ltd. Tokyo Japan
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- Takayuki Tomida
- Otsuka Pharmaceutical Company, Ltd. Tokyo Japan
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- Nobutaka Hattori
- Department of Neurology Juntendo University School of Medicine Tokyo Japan
書誌事項
- 公開日
- 2013-06-25
- 権利情報
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- http://onlinelibrary.wiley.com/termsAndConditions#vor
- DOI
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- 10.1002/mds.25537
- 公開者
- Wiley
この論文をさがす
説明
<jats:title>ABSTRACT</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>We conducted a randomized, double‐blind, placebo‐controlled trial to determine the safety and efficacy of transdermal rotigotine at doses up to 16 mg/24 hours in patients with early stage Parkinson's disease (PD) in Japan.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Patients received once‐daily rotigotine 2 to 16 mg/24 hours (mean dose, 12.8 mg/24 hours; n = 82) or placebo (n = 90) for 12 weeks. The primary endpoint was the change in Unified Parkinson's Disease Rating Scale (UPDRS) part II (activities of daily living) and part III (motor function) scores from baseline to the end of treatment.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The mean (± standard deviation) changes in UPDRS part II and III scores were −8.4 ± 9.7 in the rotigotine group and −4.1 ± 8.2 in the placebo group and were significantly different (<jats:italic>P</jats:italic> = 0.002). More patients in the rotigotine group than in the placebo group had a ≥20% score reduction. No serious drug‐related adverse events were reported.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Rotigotine at doses up to 16 mg/24 hours was well tolerated and improved function in patients with early stage PD. © 2013 International Parkinson and Movement Disorder Society</jats:p></jats:sec>
収録刊行物
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- Movement Disorders
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Movement Disorders 28 (10), 1447-1450, 2013-06-25
Wiley