NCT00125567已完成4 期
Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off
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
- 223
- 试验地点
- 19
- 主要终点
- The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms
研究概览
简要总结
The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Idiopathic Parkinson's disease
- •Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day
- •Unchanged antiparkinsonian medication for 6 weeks prior to baseline
排除标准
- •Secondary or atypical parkinsonism
- •Patients with daily unpredictable OFF periods or painful dyskinesia
研究组 & 干预措施
1
Experimental
Stalevo (levodopa/carbidopa/entacapone)
干预措施: Stalevo (levodopa/carbidopa/entacapone) (Drug)
2
Active Comparator
Levodopa/carbidopa
干预措施: Levodopa/carbidopa (Drug)
结局指标
主要结局
The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms
时间窗: Up to 2 years of treatment
次要结局
- Parkinson's Disease Questionnaire (PDQ-39)(Up to 2 years of treatment)
- Work Impairment Questionnaire(Up to 2 years of treatment)
- Unified Parkinson's Disease Rating Scale(Up to 2 years of treatment)
- Clinical Global Impression of Change (investigator)(Up to 2 years of treatment)
研究者
研究点 (19)
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