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临床试验/NCT00902941
NCT00902941已完成4 期

Reversibility of Olfactory Loss in Patients With Idiopathic Parkinson's Disease Following Treatment With Rasagiline

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
34
试验地点
1
主要终点
olfactory function

研究概览

简要总结

There is convincing evidence from numerous studies using both psychophysical and electrophysiological approaches that olfaction is markedly reduced in Parkinson´s disease (PD). Data on the prevalence of olfactory dysfunction in PD however, range from 45% and 49% in the pioneering studies of Ansari & Johnson, and Ward, respectively, up to 74% in the work of Hawkes et al., or as high as 90% in a study published by Doty et al. Quality of life, safety, and interpersonal relations, as well as food behavior/nutritional intake are severely altered in a large proportion of patients with olfactory loss. Thus, the same can be assumed in patients with Parkinson's disease. If it was possible to improve olfactory function this would appear as a significant effect in patients with Parkinson's disease. Provided the study would reveal an improvement of olfactory function following therapy with rasagiline, this would have tremendous worldwide impact on the use of this drug. Considering the frequency of PD a very large number of patients would benefit from these findings, especially in terms of quality of life.

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 (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Parkinson´s disease, Hoehn & Yahr stage ≤ III
  • aged 18-64 yrs
  • hyposmia/functional anosmia defined as TDI<30
  • written consent

排除标准

  • congenital olfactory loss
  • significant infections of the nose and nasal sinuses
  • diseases/states apart from PD which may significantly affect olfactory function, e.g., asthma, head trauma etc.
  • dementia, psychiatric illness, addictive behaviour
  • severe liver disease
  • pregnant or breastfeeding women
  • any contraindication for the treatment with Rasagiline
  • women without reliable contraception

研究组 & 干预措施

Rasagiline

Experimental

干预措施: Azilect 1mg (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

olfactory function

时间窗: 4 months

次要结局

  • quality of life(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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