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临床试验/EUCTR2004-001485-41-ES
EUCTR2004-001485-41-ES进行中(未招募)不适用

A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease

Institute for Neurodegenerative Disorders0 个研究点目标入组 120 人开始时间: 2006年1月30日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120

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)The subject is aged 40 years or older.
  • (b)Written informed consent is obtained.
  • (c)Subjects have a diagnosis of idiopathic Parkinson’s disease.
  • (d)Hoehn and Yahr stages for subjects are I-II.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years)
  • F.1.3.1 Number of subjects for this age range

排除标准

  • (a)The subject has atypical or drug-induced Parkinson’s disease.
  • (b)The subject has dementia.
  • (c)The subject has clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
  • (d)The subject is pregnant.
  • (e)The subject has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV) {American Psychiatric Association, 1994 #2}within the past 2 years.
  • (f)The subject has received an investigational drug within 30 days before the screening visit.
  • (g)The subject has been treated with any anti-Parkinson drug including levodopa, dopamine agonists (including pramipexole, ropinirole, cabergoline, pergolide), amantadine, selegeline, rasagiline for greater than a total of 14 days or at any time within 60 days of the baseline visit.
  • (h)The subject has used any prescription or clinically significant over-the-counter (OTC) drugs disallowed by the protocol (anticholinergic drugs, dopamine antagonists, or antihistamines as identified in section 6) within 14 (60 days for antiparkinson’s agents) days before the baseline visit.

研究者

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