NCT01515774Unknown4 期
An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Patient preference
研究概览
简要总结
- In order to observe the benefit, side effects, and patient preference of Mirapex ER when used in once-daily (QD) or twice-daily (BID) dosing
- In order to estimate the conversion rate of dopamine agonists into Mirapex ER
详细描述
- Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Mirapex ER
- Cross over study design:
- Group 1: Once daily dose for 2 month then into BID in divided dose for 2 months
- Group 2: BID in divided dose for 2 months then into QD dose for 2 months
- Dose adjustment may be done in the first 4 weeks.
- Compare the benefit, side effects, and patient preference between the QD vs BID dosing
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson disease
- •On dopamine agonists (Requip or Mirapex) and are considering to change into Mirapex ER
- •On stable antiparkinsonian medication for at least 4 weeks
- •Who signed consent to the study
排除标准
- •Who are on less than 2 mg of Requip or 0.375 mg of Mirapex
- •Who have dementia, psychosis, major depression and other serious neurological or medical problems
- •Who are allergic to the similar medications
- •Who has history of heavy metal poisoning
- •Who were on othe clinical trials of other medications within the last 4 weeks
- •Who are pregnant or lactating
- •Who are considered not eligible by the investigator
研究组 & 干预措施
Group 1
Active Comparator
Give QD dose first then BID dosing
干预措施: Mirapex ER (Drug)
Group 2
Active Comparator
Give BID dosing and then QD dosing
干预措施: Mirapex ER (Drug)
结局指标
主要结局
Patient preference
时间窗: 4 months
Overall preference in QD versus BID
次要结局
- Motor complications(2 months at each arm)
- Sleep problems(2 months at each arm)
- Motor UPDRS and HY stage(2months at each arm)
- Side effects(2 months at each arm)
- Patient global impression for improvement(2 months at each arm)
- Preference in each factor(4 months)
- Patient choice(4 months)
研究者
BS Jeon
Professor
Seoul National University Hospital
研究点 (1)
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