EUCTR2006-006347-31-GB进行中（未招募）1 期
A Phase II randomised placebo controlled clinical trial of Simvastatin in patients with secondary progressive multiple sclerosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •Patients must have a confirmed diagnosis of multiple sclerosis and have progressed to the secondary progressive stage.
- •EDSS 4.0 to 6.5 inclusive
- •Men and women to be included (women of childbearing age must take effective methods of contraception)
- •Able to give written informed consent
- •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
- •Unable to give written informed consent
- •Patients with primary progressive MS
- •Those that have experienced a relapse or have been treated with steroids within 3 months of the screening visit
- •Patients on any medications that unfavourably react with statins e.g. fibrates, nicotinic acid, cyclosporine, azole etc.
- •Patients on immunosuppressive medicines e.g. avonex, rebif, betaferon etc within the previous 6 months
研究者
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