NCT00036218已完成3 期
A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 600
- 试验地点
- 103
- 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
简要总结
The primary purpose of this study is to determine whether sumanirole 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
- •Parkinson's disease of less than 7 years duration
- •Modified Hoehn and Yahr Scale Stages 1 through
- •Age greater than or equal to 30 years old.
- •Men or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.
- •Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
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; the benefit of sumanirole in quality of life measures, and change from baseline in UPDRS II + III total scores at end of maintenance, for sumanirole compared to ropinirole
研究者
研究点 (103)
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