PMID- 28827011
OWN - NLM
STAT- MEDLINE
DCOM- 20180727
LR  - 20221207
IS  - 1873-5126 (Electronic)
IS  - 1353-8020 (Linking)
VI  - 44
DP  - 2017 Nov
TI  - Rotigotine transdermal patch in Chinese patients with advanced Parkinson's 
      disease: A randomized, double-blind, placebo-controlled pivotal study.
PG  - 6-12
LID - S1353-8020(17)30297-3 [pii]
LID - 10.1016/j.parkreldis.2017.08.015 [doi]
AB  - INTRODUCTION: Rotigotine was demonstrated to be efficacious and well-tolerated in 
      three placebo-controlled studies (CLEOPATRA-PD/PREFER/SP921) of patients with 
      advanced-stage Parkinson's disease (PD), most of whom were Caucasian. This 
      multicenter phase 3 study (SP1037; NCT01646255) was the first to investigate the 
      efficacy and safety of rotigotine in Chinese patients with advanced-stage PD. 
      METHODS: Chinese patients with PD, inadequately controlled on levodopa (stable 
      dose >/=200 mg/day), with >/=2.5 h/day "off" time, and Hoehn & Yahr stage 2-4, were 
      randomized 1:1 to receive transdermal rotigotine or placebo, titrated over </=7 
      weeks, maintained at optimal/maximum dose (4-16 mg/24 h) for 12 weeks. Primary 
      efficacy variable: mean change in absolute "off" time (according to patient 
      diaries) from baseline to end of maintenance. Safety variables included adverse 
      events (AEs) and discontinuations due to AEs. RESULTS: 346 patients were 
      randomized and 89.9% completed the study (87.8% placebo; 92.0% rotigotine). All 
      were Chinese (58.7% male; mean +/- SD age: 62.2 +/- 8.9 years; mean +/- SD time since 
      PD diagnosis: 6.62 +/- 3.70 years). Rotigotine significantly reduced "off" time vs 
      placebo (LS mean [95% CI] treatment difference: -1.20 h/day [-1.83, -0.57]; 
      p = 0.0002), and resulted in more responders (>/=30% decrease in "off" time: 36.9% 
      placebo; 48.8% rotigotine; p = 0.0269). AEs were reported for 86 (50.0%) placebo- 
      and 103 (59.2%) rotigotine-treated patients; 15 discontinued due to AEs (placebo 
      7; rotigotine 8). The most common AEs (>/=5%) were dizziness, nausea, pruritus, and 
      dyskinesia. CONCLUSIONS: Rotigotine was efficacious in Chinese patients with 
      advanced-stage PD as add-on therapy to levodopa, significantly reducing "off" 
      time vs placebo; the treatment difference was similar to that observed in 
      previous studies of mainly Caucasian patients. Rotigotine was generally 
      well-tolerated and had a similar AE profile to those observed in previous 
      studies.
CI  - Copyright (c) 2017 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 - Liu, Chun-Feng
AU  - Liu CF
AD  - Second Affiliated Hospital of Soochow University, Suzhou, China.
FAU - Tao, En-Xiang
AU  - Tao EX
AD  - Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
FAU - Shao, Ming
AU  - Shao M
AD  - First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
FAU - Liu, Yi-Ming
AU  - Liu YM
AD  - Qilu Hospital Affiliated to Shandong University, Jinan, China.
FAU - Wang, Jian
AU  - Wang J
AD  - Huashan Hospital, Fudan University, Shanghai, China.
FAU - Asgharnejad, Mahnaz
AU  - Asgharnejad M
AD  - UCB Pharma, Raleigh, NC, USA.
FAU - Xue, Hai-Bo
AU  - Xue HB
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.
LA  - eng
SI  - ClinicalTrials.gov/NCT01646255
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170810
PL  - England
TA  - Parkinsonism Relat Disord
JT  - Parkinsonism & related disorders
JID - 9513583
RN  - 0 (Antiparkinson Agents)
RN  - 0 (Dopamine Agonists)
RN  - 0 (Tetrahydronaphthalenes)
RN  - 0 (Thiophenes)
RN  - 87T4T8BO2E (rotigotine)
SB  - IM
MH  - Aged
MH  - Antiparkinson Agents/*administration & dosage/adverse effects
MH  - Asian People
MH  - Dopamine Agonists/administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Parkinson Disease/*drug therapy
MH  - Tetrahydronaphthalenes/*administration & dosage/adverse effects
MH  - Thiophenes/*administration & dosage/adverse effects
MH  - Transdermal Patch
OTO - NOTNLM
OT  - Advanced-stage Parkinson's disease
OT  - Chinese
OT  - Rotigotine
OT  - Treatment
EDAT- 2017/08/23 06:00
MHDA- 2018/07/28 06:00
CRDT- 2017/08/23 06:00
PHST- 2016/12/21 00:00 [received]
PHST- 2017/05/18 00:00 [revised]
PHST- 2017/08/08 00:00 [accepted]
PHST- 2017/08/23 06:00 [pubmed]
PHST- 2018/07/28 06:00 [medline]
PHST- 2017/08/23 06:00 [entrez]
AID - S1353-8020(17)30297-3 [pii]
AID - 10.1016/j.parkreldis.2017.08.015 [doi]
PST - ppublish
SO  - Parkinsonism Relat Disord. 2017 Nov;44:6-12. doi: 
      10.1016/j.parkreldis.2017.08.015. Epub 2017 Aug 10.