A Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.

Pfizer135 个研究点分布在 2 个国家目标入组 854 人开始时间: 2003年4月1日最近更新: 2006年6月7日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Pfizer
入组人数: 854
试验地点: 135
主要终点: Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary purpose of this study is to determine whether sumanirole, at three different dose levels, is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 30 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Idiopathic Parkinson's disease < 7 years duration
•Modified Hoehn and Yahr Scale Stages I through III
•Age greater than or equal to 30 years old
•Patients or their partners must use adequate contraceptive methods
•Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and do not plan on traveling extensively during the study

排除标准

•Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
•Levodopa received for 1-year accumulated interval in the last two years.
•Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days prior to baseline.
•Unstable dose regimes of hypnotics, anxiolytics or antidepressants
•History of stereotaxic brain surgery, psychosis or active epilepsy within past year.
•Participation in clinical trial within the previous 30 days.
•Malignant melanoma or history of melanoma
•Significant medical or pshychiatric condition

结局指标

主要结局

Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo

次要结局

To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (135)

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