NCT00143026已完成4 期
Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 184
- 试验地点
- 22
- 主要终点
- Quality of life assessment
研究概览
简要总结
This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations.
详细描述
This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations. Treatment with carbidopa/levodopa/entacapone will be compared with treatment with standard formulation levodopa/carbidopa.
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
- Double
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
- •Clinical diagnosis of idiopathic Parkinson's disease exhibiting at least 2 or 3 symptoms
- •Motor functions must be regarded as non-disabling by the patient
排除标准
- •History, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism
- •History of dyskinesia
- •Previous or current use of entacapone or tolcapone
- •Unstable Parkinson's disease patients requiring/receiving regimens of levodopa
- •Subjects taking levodopa/DDCI controlled release or extended release formulations
结局指标
主要结局
Quality of life assessment
次要结局
- Change from baseline in proportion of patients experiencing wearing-off
- Symptom control change from baseline
- Change from baseline in number of wearing-off symptoms
研究者
研究点 (22)
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