EUCTR2008-008065-35-SE进行中（未招募）不适用
A multi-centre and prospective trial to evaluate the effects on mul-tiple sclerosis related fatigue during treatment with Tysabri® in patients with relapsing remitting multiple sclerosis over the course of 12 months - TYNERGY
BiogenIdec A/S0 个研究点目标入组 200 人开始时间: 2008年12月17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
- 200
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
- •Age = 18 years and age = 65 years at screening
- •Subjects who have been prescribed Tysabri® according to national guidelines but not yet started treatment
- •Signed informed consent form (ICF)
- •FSMC sum score = 43 at baseline (mild fatigue)
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •FSMC sum score < 43 at baseline
- •History of treatment with Tysabri®
- •EDSS = 6 at baseline
- •Amphetamine as medication
- •Major depression
研究者
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