NCT01081782已完成2 期
A Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 86
- 主要终点
- Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis over a 26-week treatment period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female aged 18-55 years inclusive at screening
- •Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis
排除标准
- •Multiple Sclerosis course other than relapsing-remitting multiple sclerosis
- •History of malignancy
- •History of clinically significant chronic disease of the immune system (other than Multiple Sclerosis)
- •Inability to undergo Gd-enhanced MRI scans
- •Diagnosis of diabetes mellitus (type I or type II)
研究组 & 干预措施
E1
Experimental
干预措施: ONO-4641 (Drug)
E2
Experimental
干预措施: ONO-4641 (Drug)
E3
Experimental
干预措施: ONO-4641 (Drug)
P
Placebo Comparator
干预措施: ONO-4641 placebo (Drug)
结局指标
主要结局
Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.
时间窗: 26 weeks
次要结局
- Total volume of Gd-enhanced lesions(26 weeks)
研究者
研究点 (86)
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