PMID- 27172830
OWN - NLM
STAT- MEDLINE
DCOM- 20180205
LR  - 20191210
IS  - 1873-5126 (Electronic)
IS  - 1353-8020 (Linking)
VI  - 28
DP  - 2016 Jul
TI  - Rotigotine transdermal patch in Chinese patients with early Parkinson's disease: 
      A randomized, double-blind, placebo-controlled pivotal study.
PG  - 49-55
LID - S1353-8020(16)30126-2 [pii]
LID - 10.1016/j.parkreldis.2016.04.022 [doi]
AB  - 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.
CI  - Copyright (c) 2016 Elsevier Ltd. All rights reserved.
FAU - Zhang, Zhen-Xin
AU  - Zhang ZX
AD  - Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, 
      Beijing, China.
FAU - Shang, Hui-Fang
AU  - Shang HF
AD  - West China Hospital, Sichuan University, Chengdu, Sichuan, China.
FAU - Hu, Xingyue
AU  - Hu X
AD  - Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University, 
      Zhejiang, China.
FAU - Chen, Shengdi
AU  - Chen S
AD  - Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, 
      Shanghai, China.
FAU - Zhao, Zhongxin
AU  - Zhao Z
AD  - Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, 
      China.
FAU - Du, Xinlu
AU  - Du X
AD  - UCB Pharma, Shanghai, China.
FAU - Surmann, Erwin
AU  - Surmann E
AD  - UCB Pharma, Monheim am Rhein, Germany.
FAU - Bauer, Lars
AU  - Bauer L
AD  - UCB Pharma, Monheim am Rhein, Germany. Electronic address: lars.bauer@ucb.com.
FAU - Asgharnejad, Mahnaz
AU  - Asgharnejad M
AD  - UCB Pharma, Raleigh, NC, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160427
PL  - England
TA  - Parkinsonism Relat Disord
JT  - Parkinsonism & related disorders
JID - 9513583
RN  - 0 (Dopamine Agonists)
RN  - 0 (Tetrahydronaphthalenes)
RN  - 0 (Thiophenes)
RN  - 87T4T8BO2E (rotigotine)
SB  - IM
CIN - Parkinsonism Relat Disord. 2017 May;38:108. PMID: 28258926
MH  - Adult
MH  - Aged
MH  - China
MH  - Dopamine Agonists/administration & dosage/adverse effects/*pharmacology
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Outcome Assessment, Health Care
MH  - Parkinson Disease/*drug therapy
MH  - Tetrahydronaphthalenes/administration & dosage/adverse effects/*pharmacology
MH  - Thiophenes/administration & dosage/adverse effects/*pharmacology
MH  - Transdermal Patch
OTO - NOTNLM
OT  - Chinese
OT  - Parkinson's disease
OT  - Rotigotine
OT  - Treatment
EDAT- 2016/05/14 06:00
MHDA- 2018/02/06 06:00
CRDT- 2016/05/14 06:00
PHST- 2016/01/20 00:00 [received]
PHST- 2016/04/15 00:00 [revised]
PHST- 2016/04/21 00:00 [accepted]
PHST- 2016/05/14 06:00 [entrez]
PHST- 2016/05/14 06:00 [pubmed]
PHST- 2018/02/06 06:00 [medline]
AID - S1353-8020(16)30126-2 [pii]
AID - 10.1016/j.parkreldis.2016.04.022 [doi]
PST - ppublish
SO  - Parkinsonism Relat Disord. 2016 Jul;28:49-55. doi: 
      10.1016/j.parkreldis.2016.04.022. Epub 2016 Apr 27.