NCT00986245已完成4 期
An Open-label, Multi-center, Crossover Study to Compare the Effect of Once-daily Ropinirole PR and Twice-daily Ropinirole PR in Patients With Parkinson Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Patient Preference
研究概览
简要总结
- In order to compare the benefit, side effects, and patient preference of Ropinirole prolonged release when used in once-daily or twice-daily dosing
- In order to estimate the conversion rate of dopamine agonists into Ropinirole prolonged release
详细描述
- Study subjects : Parkinson disease who are on Ropinirole immediate release or Pramipexole immediate release and are considering to change into Ropinirole prolonged release
- Cross over study design:
- Group 1: once daily dose for 2 month then into twice daily in divided dose for 2 months
- Group 2: twice daily in divided dose for 2 months then into once daily dose for 2 months
- Dose adjustment may be done in the first 4 weeks.
- Compare the benefit,side effects, and patient preference between the once daily vs twice daily 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 (Ropinirole IR or Pramipexole IR) and are considering to change into Ropinirole PR
- •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 Ropinirole IR or 0.375 mg of Pramipexole IR
- •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
- •Whoa re pregnant or lactating
- •Who are considered not eligible by the investigator
研究组 & 干预措施
Ropinirole PR QD first, then BID
Active Comparator
Give Roipinirole prolonged release (PR) once-daily (QD) dose first, then twice-daily (BID) dosing
干预措施: Ropinirole Prolonged release (Drug)
Ropinirole PR BID first, and then QD
Active Comparator
Give Ropinirole prolonged release (PR) twice-daily (BID) dosing, and then once-daily (QD) dosing
干预措施: Ropinirole Prolonged release (Drug)
结局指标
主要结局
Patient Preference
时间窗: After 16 weeks or at last visit for early completion
Patient preference between once-daily and twice-daily regimen
次要结局
- Unified Parkinson's Disease Rating Scale, Part 3(8 weeks for each arm or at last visit)
- Hoehn and Yahr Stage(8 weeks for each arm or at last visit)
- Overall Quality of Sleep(8 weeks for each arm or at last visit)
- Nocturnal Off-symptoms(8 weeks for each arm or at last visit)
- Early Morning Off Symptoms(8 weeks for each arm or at last visit)
- Epworth Sleep Scale(8 weeks in each arm or at last visit for early completion)
- Compliance(8 weeks for each arm or at last visit)
- Adverse Events(After 8 weeks in each arm or at last visit for early completion)
- Patients Who Have Global Impression for Improvement to Duration of Dyskinesia(After 8 weeks in each arm or at last visit for early completion)
- Patients Who Have Global Impression for Improvement(After 8 weeks in each arm or at last visit for early completion)
- Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation(After 8 weeks in each arm or at last visit for early completion)
- Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation(After 8 weeks in each arm or at last visit for early completion)
- Patients Who Have Global Impression for Improvement to Severity of Dyskinesia(After 8 weeks in each arm or at last visit for early completion)
研究者
BS Jeon
Professor
Seoul National University Hospital
研究点 (2)
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