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临床试验/EUCTR2018-003219-23-GB
EUCTR2018-003219-23-GB进行中(未招募)1 期

CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson’s Disease): A phase 3 randomised double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson’s disease - CHIEF-PD

niversity of Bristol0 个研究点目标入组 600 人开始时间: 2019年6月4日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
600

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • a.Diagnosis of idiopathic Parkinson’s disease.
  • b.Modified Hoehn and Yahr stage 1-4 disease.
  • c.Have experienced a fall in the previous year.
  • d.Able to walk =10m without aids or assistance.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 125
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 475

排除标准

  • a.Previous ChEi use in 12 months prior to enrolment.
  • b.Hypersensitivity to rivastigmine
  • c.Dementia diagnosed according to Movement Disorder Society (MDS) criteria.
  • d.Inability to attend or comply with treatment or follow-up scheduling.
  • e.Non-English-speaking patients (cognitive tests performed in English).
  • f.Falling =4x per day.
  • g.Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential.

研究者

发起方
niversity of Bristol

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