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临床试验/NCT04453995
NCT04453995Unknown不适用

A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年1月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
the occurrence of dyskinesia and its related predicting factors

研究概览

简要总结

Parkinson' patients who have not had dyskinesia would be observed for 2 years in a multicenter prospective study with the purposes to clarify the predicting factors of dyskinesia.

详细描述

Parkinson' patients with daily levodopa dosage above 200mg and no dyskinesia would be recruited into the study. They would be observed for two years for analyzed the predicting factors of dyskinesia. At the baseline, demographic information, Clinical information, blood sample, picture of tongure coating would be collected at the baseline. All participants were evaluated every three months for two years. The severity of motor symptoms were evaluated every 6 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients have been clinically diagnosed with Parkinson disease at the recruitment.
  • Patients have received Levodopa treatment with the daily dosage above 200mg.

排除标准

  • be suspicious of atypical Parkinson or other Parkinson syndrome. 2) have experienced dyskinesia. 3) incorporation to the investigation

结局指标

主要结局

the occurrence of dyskinesia and its related predicting factors

时间窗: The data would be analyzed within 9 months of the study completion. The outcome would be reported within 1 year of the the study completion.

to evaluate the occurrence of dyskinesia during the 2 years of follow-up and identify its predicting factors of dyskinesia

次要结局

  • to evaluate patients ' living quality and the severity of non motor symptoms during the 2 years of follow-up(The data would be analyzed within 9 months of the study completion. The outcome would be reported within 1 year of the the study completion.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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