NCT00468611终止3 期
A Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 510
- 主要终点
- Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment
研究概览
简要总结
This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male of female subjects, 18-65 years of age with a diagnosis of SPMS
- •HLA DR2 and/or DR4 positive
- •Absence of a relapse in the 3 months prior to baseline
- •EDSS of 3.0 - 6.5
排除标准
- •Therapy with Beta-interferon, glatiramer acetate within 3 months or mitoxantrone, cyclophosphamide, methotrexate, azathioprine or any immune modulating or immunosuppressive drugs within 6 months of baseline
- •Treatment with Tysabri within 2 years of baseline
- •Females who are breast feeding, pregnant (pregnancy test at baseline) or not using a medically approved method of contraception regularly
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
干预措施: MBP8298 (Drug)
2
Placebo Comparator
干预措施: MBP8298 (Drug)
结局指标
主要结局
Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment
时间窗: 24 Months
次要结局
- To assess the safety of MBP8298, degree of change in the EDSS scores, effect of MBP8298 on MRI parameters, difference in relapse rates, effect on MSFC, subject's quality of life (MSQoL54) and fatigue (MFIS) after 24 months of treatment(24 Months)
研究者
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