title: Rotigotine transdermal patch in Chinese patients with early Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study.
abstract: 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.
  
  
  
  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.
  
  
  
  Of 247 patients randomized, 113/124 (91.1%) rotigotine- and 107/123 (87.0%) placebo-treated patients completed the study.
  
  
  
  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).
  
  
  
  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.
authors.affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Zhen-Xin
authors.initials: ZX
authors.lastname: Zhang
authors.affiliation: West China Hospital, Sichuan University, Chengdu, Sichuan, China.
authors.forename: Hui-Fang
authors.initials: HF
authors.lastname: Shang
authors.affiliation: Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University, Zhejiang, China.
authors.forename: Xingyue
authors.initials: X
authors.lastname: Hu
authors.affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Shengdi
authors.initials: S
authors.lastname: Chen
authors.affiliation: Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Zhongxin
authors.initials: Z
authors.lastname: Zhao
authors.affiliation: UCB Pharma, Shanghai, China.
authors.forename: Xinlu
authors.initials: X
authors.lastname: Du
authors.affiliation: UCB Pharma, Monheim am Rhein, Germany.
authors.forename: Erwin
authors.initials: E
authors.lastname: Surmann
authors.affiliation: UCB Pharma, Monheim am Rhein, Germany. Electronic address: lars.bauer@ucb.com.
authors.forename: Lars
authors.initials: L
authors.lastname: Bauer
authors.affiliation: UCB Pharma, Raleigh, NC, USA.
authors.forename: Mahnaz
authors.initials: M
authors.lastname: Asgharnejad
mesh_terms: D000328:Adult; D000368:Aged; D002681:China; D018491:Dopamine Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010300:Parkinson Disease / Q000188:drug therapy*; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D057968:Transdermal Patch
chemical_list: D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine
keywords: Chinese; Parkinson's disease; Rotigotine; Treatment