NCT00260793Unknown3 期
Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease
Agarwal, Pinky, M.D.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
研究概览
简要总结
The purpose of this research study is to see if subjects with Parkinson's disease who are experiencing motor fluctuations ("on" and "off" states) and dyskinesias (involuntary excessive movements) would benefit from a higher dose of Requip as compared to the maximum FDA approved dose of dopamine agonist drugs (including Requip, Mirapex, and Permax). Requip as used in this study is investigational, which means it has not been approved by the US Food and Drug Administration (FDA) at this dose level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must give written informed consent prior to any specific study procedures.
- •Males or females; females of childbearing age who are not currently pregnant must agree to use a medically accepted method of contraception throughout the study.
- •Age greater than or equal to 25 years.
- •Patients must be on a maximum dose of dopamine agonist drug (pergolide 4mg/day, pramipexole 4.5 mg/day or ropinirole 24mg/day).
- •Stable dose of all medications for 4 weeks.
排除标准
- •Current hallucinations.
- •History of disabling hallucinations or hallucinations in past requiring treatment.
- •Troublesome edema (swelling).
- •Unstable depression.
- •Female who is pregnant or lactating.
- •Use of an investigational drug with in the last 30 days.
- •Other inclusion or exclusion criteria to be evaluated by the physician.
研究者
研究点 (2)
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