EUCTR2005-002611-25-ES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 510 人开始时间: 2006年1月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 510
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
- •1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
- •2. Subject completed the 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 (SAE) 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 child-bearing potential who is not surgically sterile, 2 years postmenopausal, 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 or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject’s ability to participate in this trial.
研究者
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