Rotigotine transdermal patch in Chinese patients with early Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study.


INTRODUCTION:Two phase3 studies (SP512; SP513) involving mostly Caucasian patients showed that rotigotine (≤8 mg/24 h) was efficacious and welltolerated in early-stage Parkinson's disease (PD). We report results from a phase 3 study (SP0914/NCT01646268) investigating rotigotine in Chinese patients with early-stage PD. METHODS:Patients were randomized 1:1 to rotigotine or placebo, titrated over 1-4 weeks, maintained at optimal/maximum dose (≤8 mg/24 h) for 24 weeks. Primary efficacy variable: change in Unified Parkinson's Disease Rating Scale (UPDRS) II + III total score from Baseline to End-of-Maintenance. Secondary variables: UPDRS II + III responders (≥20% decrease in UPDRS II + III) and changes in UPDRS II (activities of daily living [ADL]) and III (motor examination) subscores. RESULTS:Of 247 patients randomized, 113/124 (91.1%) rotigotine- and 107/123 (87.0%) placebo-treated patients completed the study. PATIENTS:mean (SD) age: 59.4 (10.2) years; time since PD diagnosis: 1.01 (1.22) years, 60.7% male. Rotigotine significantly improved UPDRS II + III total score (change from Baseline LSmean [95%CI] treatment difference, -4.82 [-7.18 to -2.45]; P < 0.0001). UPDRS II + III responder rates were higher with rotigotine (42.3% vs 22.3%; P = 0.0006). UPDRS II and III subscores improved with rotigotine (both subscores: P < 0.0005 vs. placebo). Most frequent adverse events (AEs): nausea (8.9% rotigotine, 3.3% placebo), dizziness (8.1%, 5.7%), pruritus (8.1%, 4.1%), somnolence (8.1%, 3.3%), erythema (6.5%, 1.6%), and vomiting (5.6%, 1.6%). Thirteen (5.3%) patients discontinued due to AEs (6 rotigotine, 7 placebo). CONCLUSIONS:Rotigotine was efficacious in Chinese patients with early-stage PD, providing benefits to control of ADL and motor function. Rotigotine was generally welltolerated, with similar AEs to those observed in Caucasian patients.


Zhang ZX,Shang HF,Hu X,Chen S,Zhao Z,Du X,Surmann E,Bauer L,Asgharnejad M




Has Abstract


2016-07-01 00:00:00












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    authors: Ballard CG,Kreitzman DL,Isaacson S,Liu IY,Norton JC,Demos G,Fernandez HH,Ilic TV,Azulay JP,Ferreira JJ,Abler V,Stankovic S,015 Study Group.

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    authors: Okuma Y,Shimo Y,Hatori K,Hattori T,Tanaka S,Mizuno Y

    更新日期:1997-04-01 00:00:00

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    pub_type: 临床试验,杂志文章,随机对照试验


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    更新日期:2014-12-01 00:00:00

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    pub_type: 杂志文章,多中心研究,随机对照试验


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    更新日期:2015-05-01 00:00:00

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    pub_type: 临床试验,杂志文章


    authors: Visser-Vandewalle V,van der Linden C,Temel Y,Celik H,Ackermans L,Spincemaille G,Caemaert J

    更新日期:2005-05-01 00:00:00

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    pub_type: 杂志文章,评审


    authors: Pal PK,Wszolek ZK,Uitti R,Markopoulou K,Calne SM,Stoessl AJ,Calne DB

    更新日期:2001-09-01 00:00:00

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    pub_type: 杂志文章,多中心研究


    authors: Geraedts VJ,Kuijf ML,van Hilten JJ,Marinus J,Oosterloo M,Contarino MF

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    pub_type: 杂志文章,随机对照试验


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    pub_type: 杂志文章


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    pub_type: 杂志文章


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    pub_type: 杂志文章


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    更新日期:2007-03-01 00:00:00

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    pub_type: 杂志文章


    authors: Fasano A,Evoli A,Piano C,Tonali PA,Bentivoglio AR

    更新日期:2008-01-01 00:00:00

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    journal_title:Parkinsonism & related disorders

    pub_type: 杂志文章,评审


    authors: Ha D,Stone DK,Mosley RL,Gendelman HE

    更新日期:2012-01-01 00:00:00

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    journal_title:Parkinsonism & related disorders

    pub_type: 杂志文章


    authors: Gambhir H,Mathur R,Behari M

    更新日期:2011-07-01 00:00:00

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    journal_title:Parkinsonism & related disorders

    pub_type: 杂志文章


    authors: Lin IS,Wu RM,Lee-Chen GJ,Shan DE,Gwinn-Hardy K

    更新日期:2007-05-01 00:00:00

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    journal_title:Parkinsonism & related disorders

    pub_type: 杂志文章


    authors: McRae C,Diem G,Vo A,O'Brien C,Seeberger L

    更新日期:2002-01-01 00:00:00