EUCTR2012-003056-36-GR进行中（未招募）1 期
A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,530
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
- •Prior history of relapsing remitting MS
- •Secondary progressive multiple sclerosis (SPMS) defined as progressive increase of disability in at least 6 months
- •EDSS score of 3.0 to 6.5
- •No relapse or corticosteroid treatment within 3 months
- •Other protocol-defined inclusion criteria may apply
- •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 1530
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Women of child bearing potential must use reliable forms of contraception.
- •Diagnosis of Macular edema during screening period
- •Any medically unstable condition determined by investigator
- •Unable to undergo MRI scans
- •Hypersensitivity to any study drugs or drugs of similar class
- •Other protocol-defined exclusion criteria may apply
研究者
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