EUCTR2012-000541-12-BG进行中（未招募）1 期
Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •- Signed informed consent prior to initiation of any study-mandated procedure.
- •- Women of childbearing potential must have a negative pregnancy test and use reliable methods of contraception
- •- Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed relapses).
- •- Ongoing treatment with DMF for at least 6 months prior to screening;
- •- Active disease in the 12 months prior to screening and after at least 3 months of DMF treatment
- •- Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).
- •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 600
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Lactating or pregnant women and women intending to become pregnant during the study.
- •- Presenting with a diagnosis of MS with progressive course from onset (i.e., primary progressive MS or progressive relapsing MS).
- •- Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS assessment.
- •- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
研究者
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