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Rotigotine transdermal patch in Chinese patients with early Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study.
Parkinsonism Relat Disord. 2016 07; 28:49-55.PR

Abstract

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.

Authors+Show Affiliations

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.West China Hospital, Sichuan University, Chengdu, Sichuan, China.Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University, Zhejiang, China.Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China.UCB Pharma, Shanghai, China.UCB Pharma, Monheim am Rhein, Germany.UCB Pharma, Monheim am Rhein, Germany. Electronic address: lars.bauer@ucb.com.UCB Pharma, Raleigh, NC, USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27172830

Citation

Zhang, Zhen-Xin, et al. "Rotigotine Transdermal Patch in Chinese Patients With Early Parkinson's Disease: a Randomized, Double-blind, Placebo-controlled Pivotal Study." Parkinsonism & Related Disorders, vol. 28, 2016, pp. 49-55.
Zhang ZX, Shang HF, Hu X, et al. Rotigotine transdermal patch in Chinese patients with early Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study. Parkinsonism Relat Disord. 2016;28:49-55.
Zhang, Z. X., Shang, H. F., Hu, X., Chen, S., Zhao, Z., Du, X., Surmann, E., Bauer, L., & Asgharnejad, M. (2016). Rotigotine transdermal patch in Chinese patients with early Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study. Parkinsonism & Related Disorders, 28, 49-55. https://doi.org/10.1016/j.parkreldis.2016.04.022
Zhang ZX, et al. Rotigotine Transdermal Patch in Chinese Patients With Early Parkinson's Disease: a Randomized, Double-blind, Placebo-controlled Pivotal Study. Parkinsonism Relat Disord. 2016;28:49-55. PubMed PMID: 27172830.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rotigotine transdermal patch in Chinese patients with early Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study. AU - Zhang,Zhen-Xin, AU - Shang,Hui-Fang, AU - Hu,Xingyue, AU - Chen,Shengdi, AU - Zhao,Zhongxin, AU - Du,Xinlu, AU - Surmann,Erwin, AU - Bauer,Lars, AU - Asgharnejad,Mahnaz, Y1 - 2016/04/27/ PY - 2016/01/20/received PY - 2016/04/15/revised PY - 2016/04/21/accepted PY - 2016/5/14/entrez PY - 2016/5/14/pubmed PY - 2018/2/6/medline KW - Chinese KW - Parkinson's disease KW - Rotigotine KW - Treatment SP - 49 EP - 55 JF - Parkinsonism & related disorders JO - Parkinsonism Relat Disord VL - 28 N2 - 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. SN - 1873-5126 UR - https://www.unboundmedicine.com/medline/citation/27172830/Rotigotine_transdermal_patch_in_Chinese_patients_with_early_Parkinson's_disease:_A_randomized_double_blind_placebo_controlled_pivotal_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1353-8020(16)30126-2 DB - PRIME DP - Unbound Medicine ER -