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临床试验/NCT01338662
NCT01338662Unknown不适用

A 10-year Observational Study of the Incidence of Dyskinesia in Patients With Early Parkinson's Disease Who Were Treated With Amantadine or Dopamine Agonist

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2011年5月最近更新:
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适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
dyskinesia onset
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to compare the onset time and severity of dyskinesia in amantadine or Dopamine agonist initial treated groups in Parkinson's disease.

详细描述

  1. Dopamine agonist can delay the risk of dyskinesia by initiating treatment rather than levodopa. Amantadine is typical antidyskinetic drug. There is no data about comparison of risk of dyskinesia in amantadine and dopamine agonist by initiating treatment.
  2. Prospective , randomized, open label study compare the onset time and severity of dyskinesia between groups randomized assigned order of amantadine and dopamine agonist

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
30 Years 至 60 Years（Adult）
性别
All
接受健康志愿者
否

入选标准

  • •30<age<60
  • •H & Y<3

排除标准

  • •previous dopaminergic medication history
  • •dyskinesia
  • •Parkinson plus
  • •clinically significant or unstable medical or surgical condition

结局指标

主要结局

dyskinesia onset

时间窗: up to 10 years from the start of durg (Amantadine or dopaimine agonsit)

observe duration of onset of dyskinesia from initial treatment observe until 10 years

次要结局

  • UPDRS, severity of dyskinesia between groups(observe duration of onset of dyskinesia from initial treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

BS Jeon

Professor

Seoul National University Hospital

研究点 (1)

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