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临床试验/NCT00143026
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.

Novartis22 个研究点 分布在 4 个国家目标入组 184 人开始时间: 2005年7月1日最近更新:
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

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

发起方
Novartis
申办方类型
Industry
责任方
Sponsor

研究点 (22)

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