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临床试验/NCT00244387
NCT00244387已完成3 期

A Multi-centre, Multi-national, Phase 3, Randomized, Double-blind, Double-dummy, 3- Arm Parallel Group, Placebo- and Pramipexole- Controlled Trial of the Efficacy and Safety of Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa

UCB Pharma1 个研究点 分布在 1 个国家目标入组 506 人开始时间: 2004年3月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
UCB Pharma
入组人数
506
试验地点
1

研究概览

简要总结

Male and female patients aged ≥ 30 years with advanced stage idiopathic Parkinson's disease, not well controlled on existing levodopa will take part in a research study at approximately 82 sites in Europe, Israel, South Africa, Australia and new Zealand.

The purpose of the study is to evaluate the effectiveness, safety and tolerability of the rotigotine patch (SPM 962) at an individual patient's optimal dose for a period of 4 months

Each patient who qualifies and chooses to participate in the study will receive either rotigotine, pramipexole, or placebo at gradually increasing doses over a period of up to 7 weeks, and then maintain their optimal dose for 4 months.

The study clinic visits will include a medical history and physical exam, ECG, blood and urine sample collection, completion of various questionnaires, and completion of a diary to record the severity of their Parkinson's symptoms.

Patients who complete the study may enroll in an extension trial and receive active study drug.

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

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Advanced stage idiopathic Parkinson's disease

排除标准

  • Well controlled on levodopa

研究者

发起方
UCB Pharma
申办方类型
Industry

研究点 (1)

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