ACTRN12607000124437招募中3 期
A Randomized, Multicentre, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Safety and Efficacy of BG00012 in Subjects with Relapsing Remitting Multiple Sclerosis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Biogen Idec
- 入组人数
- 1,011
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of relapsing remitting multiple sclerosis according to McDonald criteria #1-4At least 1 relapse within 12 months prior to randomization with cranial MRI demonstrating MS consistent lesions, OR evidence of Gadolinium enhancing brain lesions on MRI within 6 weeks prior to randomisationBaseline Expanded Disability Status Score (EDSS) between 0.0 and 5.0.
排除标准
- •Primary progressive, secondary progressive or progressive relapsing Multiple SclerosisAn MS relapse within 50 days of randomisation OR a patient who has not stabilised from a previous relapse prior to randomisationInability to perform Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) with both upper extremities, PASAT 3, or Visual Function testHistory of MalignancyHistory of severe allergic or anaphylactic reactions/known drug hypersensitivityHistory of HIVHistory of Drug or Alcohol abuse in last 2 yearsPositive for Hep C antibody and/or Hep B surface antigenAbnormal laboratory results indicative of major disease which would preclude clinical trial participationAny previous treatment with FUMADERM or BG00012/FAG-201History of other disallowed medication use outside of the time-frames specified in the protocolWomen of child-bearing potential not using adequate contraceptionEnrolment in other clinical trials within 6 months prior to randomisation.
研究者
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