EUCTR2005-002611-25-GB进行中（未招募）1 期
An open label extension trial to investigate the safety and tolerability of long-term treatment with transdermal rotigotine in subjects with idiopathic restless legs syndrome
SCHWARZ BIOSCIENCES GmBH0 个研究点目标入组 420 人开始时间: 2005年9月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 420
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
入选标准
- •1. Subject is informed and given ample time / opportunity to think about participation and has given written consent
- •2. Subject completed Maintenance period and taper period of SP790 or SP794
- •3. Subject understands the investigational nature of the trial and is willing and able to comply with the trial requirements
- •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
- •1. Subject has an ongoing serious adverse event from sp790 or sp794 that is assessed to be related to the trial medication by the investigator and / or the sponsor
- •2. Subject is pregnant, nursing or is a woman of childbearing potential who is not surgically sterile, 2 years post-menopausal or does not consistently use 2 combined effective methods of contraception, including at least 1 barrier method, unless sexually abstinent
- •3. Subject has any medical condition that, in the opinion of the investigator, can jeopardise or would compromise the subject's ability to participate in the trial
研究者
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