医学
安慰剂
临床终点
帕金森病
不利影响
左旋多巴
随机对照试验
评定量表
人口
内科学
麻醉
疾病
物理疗法
心理学
替代医学
病理
发展心理学
环境卫生
作者
Hubert H. Fernandez,David Greeley,Richard M. Zweig,Joanne Wojcieszek,Akihisa Mori,N. M. Sussman
标识
DOI:10.1016/j.parkreldis.2009.06.008
摘要
Abstract Objective 6002-US-051 was a 12-week, double-blind study evaluating the safety and efficacy of istradefylline, a selective A2A adenosine receptor antagonist, as monotherapy in patients with Parkinson's disease (PD). Methods Patients with Hoehn–Yahr stages 1–2.5 who had not received dopaminergic drugs in the past 30 days or levodopa for >30 days at anytime were randomized to 40 mg/day istradefylline or placebo. The primary efficacy outcome was the change from Baseline to Endpoint in the Unified Parkinson's Disease Rating Scale (UPDRS) Subscale III score. Safety was assessed by physical examination, laboratory tests, electrocardiograms, and adverse event monitoring. Results 176 patients comprised the intent-to-treat population. Although istradefylline showed numerically greater improvements in UPDRS Subscale III at each time point and reached statistical significance at Week 2 (LS mean difference = −1.47), it did not show statistically significant improvement from placebo for the primary endpoint (least square [LS] mean difference = −1.11). Similar proportions of patients in each group experienced treatment-emergent adverse events (63% istradefylline, 65% placebo). Conclusions Istradefylline, as monotherapy in patients with PD, is safe and well tolerated. However, efficacy in improving motor symptoms in early PD was not statistically demonstrated by this study.
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