NCT01890655已完成2 期
A Phase II, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Relapsing-remitting Multiple Sclerosis Who Have Completed the MT-1303-E04 Study
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
- 367
- 试验地点
- 1
- 主要终点
- Safety assessments
研究概览
简要总结
To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the 24-week treatment period in MT-1303-E04 as per protocol
- •Able to provide written informed consent and to comply with the requirements of the protocol
- •For males and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.
排除标准
- •Permanent discontinuation of study medication prior to the end of treatment (EOT) visit in MT-1303-E04
- •Newly diagnosed diabetes mellitus during MT-1303-E04
研究组 & 干预措施
MT-1303-Low
Experimental
MT-1303-Low Dose
干预措施: MT-1303-Low (Drug)
MT-1303-Middle
Experimental
MT-1303-Middle Dose
干预措施: MT-1303-Middle (Drug)
MT-1303-High
Experimental
MT-1303-High Dose
干预措施: MT-1303-High (Drug)
结局指标
主要结局
Safety assessments
时间窗: Month 18
Adverse Events
次要结局
- Clinical efficacy(Month 18)
- Magnetic Resonance Imaging (MRI)(Month 18)
研究者
研究点 (1)
Loading locations...
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