EUCTR2004-005234-39-LV进行中（未招募）不适用
Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP
Orion Corporation, ORION PHARMA, 02200 Espoo, Finland0 个研究点目标入组 244 人开始时间: 2006年9月29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）
- 发起方
- 入组人数
- 244
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
- •Male or female patients
- •Patients with idiopathic Parkinson’s disease and end-of-dose motor-fluctuations not stabilized on their current levodopa/DDCI treatment
- •Hoehn and Yahr stage 1-3 performed during the ON” state
- •Treatment with 3 equal or unequal daily doses of standard-release levodopa/DDCI up to a maximum total daily levodopa dose of 450 mg.
- •Unchanged levodopa/DDCI and other antiparkinsonian medication (amantadine, MAO-B inhibitor with an approved dose, anticholinergics and/or dopamine agonists), if any, for at least 6 weeks prior to baseline visit
- •Age: 30 years or above
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Secondary or atypical parkinsonism
- •Patients with daily unpredictable OFF”-periods or painful dyskinesia (including painful dystonia)
- •Previous or current treatment with a COMT inhibitor
- •Current treatment with controlled-release or extended-release levodopa/DDCI preparations, except one evening (8-12pm) dose of a CR levodopa preparation to control night time symptoms is allowed.
- •Patients requiring rescue medication (including soluble levodopa formulations)
研究者
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