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临床试验/NCT00242008
NCT00242008已完成3 期

A Phase 3b, Open-Label, Multicenter, Multinational Trial To Assess The Tolerability Of Switching Subjects From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System And Its Effect On Symptoms In Subjects With Idiopathic Parkinson's Disease

UCB Pharma1 个研究点 分布在 1 个国家开始时间: 2004年12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
试验地点
1
主要终点
Effect on symptoms and other variables.

研究概览

简要总结

The purpose of this trial is to assess whether it is possible for subjects with idiopathic Parkinson's Disease to switch from ropinirole, pramipexole and cabergoline to rotigotine transdermal system (SPM 962) overnight without worsening of Parkinson's Disease symptoms.

Subjects who meet eligibility criteria will be switched overnight to treatment with rotigotine transdermal patches at a dose considered equivalent to the dose of dopamine agonist that the subject is currently taking. Subjects on ropinirole or pramipexole will take their last dose at bedtime and then apply rotigotine patch(es) upon awakening the next morning. Subjects on cabergoline will apply rotigotine patches 24 hours after the final dose of cabergoline. Subjects will continue rotigotine treatment for 28 days, during which dose can be increased or decreased as needed. At the end of treatment, subjects can select to enroll in an open-label extension trial.

The first subject was enrolled on 28 December 2004. The last subject was enrolled in June 2005 and the last subject visit was conducted in July 2005. This study is now closed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Idiopathic Parkinson's disease

排除标准

  • Not taking a dopamine agonist

结局指标

主要结局

Effect on symptoms and other variables.

Tolerability of rotigotine as determined by the total number of subjects completing the trial.

Safety.

次要结局

未报告次要终点

研究者

发起方
UCB Pharma
申办方类型
Industry

研究点 (1)

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