An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Adverse Effects Experienced
研究概览
简要总结
A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio and side effects related to the drug.
详细描述
Three different arms will be used in this study. Each of the three cohorts will be treated sequentially. Each participant will be taking Mirapex for PD and will be converted to Requip CR by 1 of 3 conversion factors (mg:mg): 1:3, 1:4 and 1:5 from Mirapex to once a day Requip CR. The first five subjects of each cohort will have their initial dose administered in the clinic and be monitored for orthostatic changes. Assessments of motor function before and after conversion will be done.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson Disease
- •Currently taking pramipexole
- •Never have taken Requip CR
排除标准
- •Can not have significant adverse effects to standard Requip
- •Can not have atypical PD due to drugs, metabolic disorders, encephalitis or degenerative diseases
- •Can not have unstable medical conditions
- •Can not be taking concurrent monoamine oxidase inhibitors except for selegiline (10mg per day or less)
- •Female patients of childbearing potential must be using an effective method of contraception.
- •Can not be pregnant or lactating.
- •This may not be a complete list; there may be additional criteria which may apply.
研究组 & 干预措施
1
Conversion factor of Mirapex to Requip 24-Hour of 1:3. This was a switch study in which the conversion factor was being investigated to assist in the conversion from Mirapex to Requip PR. In this group, the dose of Requip PR was 3 times the dose of Mirapex.
干预措施: Requip PR (Drug)
1
Conversion factor of Mirapex to Requip 24-Hour of 1:3. This was a switch study in which the conversion factor was being investigated to assist in the conversion from Mirapex to Requip PR. In this group, the dose of Requip PR was 3 times the dose of Mirapex.
干预措施: Mirapex (Drug)
2
Conversion factor of Mirapex to Requip 24-Hour of 1:4
干预措施: Requip PR (Drug)
2
Conversion factor of Mirapex to Requip 24-Hour of 1:4
干预措施: Mirapex (Drug)
3
Conversion factor of Mirapex to Requip 24-Hour of 1:5
干预措施: Requip PR (Drug)
3
Conversion factor of Mirapex to Requip 24-Hour of 1:5
干预措施: Mirapex (Drug)
结局指标
主要结局
Adverse Effects Experienced
时间窗: Week 4
Number of adverse effect experienced by participants in the different conversion ratio groups.
次要结局
- Number of Dose Adjustments(Week 4)
研究者
Rajesh Pahwa, MD
Professor and Director, Parkinson's Disease and Movement Disorder Center
University of Kansas Medical Center