Zesiewicz Theresa A, Chriscoe Stephen, Jimenez Theresa, Upward James, VanMeter Susan
University of South Florida, Tampa, FL, USA.
GlaxoSmithKline, Research Triangle Park, Raleigh-Durham, NC, USA.
Neurodegener Dis Manag. 2017 Feb;7(1):49-59. doi: 10.2217/nmt-2016-0039. Epub 2017 Jan 25.
This Phase IV, double-blind, randomized, parallel-group study characterized the dose-response and tolerability of fixed doses of ropinirole prolonged release (PR).
PATIENTS & METHODS: Subjects with early Parkinson's disease (PD) received placebo or ropinirole PR 2, 4, 8, 12 or 24 mg once daily, up-titrated to randomized or highest tolerated dose, maintained for 4 weeks.
The primary end point was not met (change from baseline in Unified PD Rating Scale motor score). However, because the data were not normally distributed, prespecified nonparametric analysis of covariance suggested ropinirole PR (8 and 12 mg/day) was effective in treating motor symptoms. The adverse event profile was consistent with the known safety profile of ropinirole PR. There was no impulse control disorder reported. Although a higher than previously reported rate of sudden onset of sleep events was reported, these were not dose dependent and were likely to have been influenced by the method of data collection.
The adverse event profile was consistent with the known safety profile of ropinirole PR and ropinirole PR (8 or 12 mg/day) improved motor symptoms of early PD.
本IV期、双盲、随机、平行组研究对固定剂量的罗匹尼罗缓释片（PR）的剂量反应和耐受性进行了表征。
早期帕金森病（PD）患者接受安慰剂或每日一次2、4、8、12或24毫克的罗匹尼罗PR治疗，剂量滴定至随机或最高耐受剂量，维持4周。
未达到主要终点（统一帕金森病评定量表运动评分相对于基线的变化）。然而，由于数据非正态分布，预先指定的非参数协方差分析表明罗匹尼罗PR（8毫克/天和12毫克/天）对治疗运动症状有效。不良事件谱与罗匹尼罗PR已知的安全性谱一致。未报告冲动控制障碍。尽管报告的睡眠事件突然发作率高于之前报道，但这些事件与剂量无关，可能受到数据收集方法的影响。
不良事件谱与罗匹尼罗PR已知的安全性谱一致，且罗匹尼罗PR（8毫克/天或12毫克/天）改善了早期PD的运动症状。
