A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) vs Intravenous Methylprednisolone (Solu-Medrol®) Treatment in Patients With Acute Exacerbation of Relapsing-remitting Multiple Sclerosis or in Patients With Clinically Isolated Syndrome (CIS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Galapagos NV
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.
研究概览
简要总结
Patients with an acute exacerbation of Relapsing-Remitting Multiple Sclerosis or with Clinically Isolated Syndrome receive either one single infusion of Nanocort or three daily infusions of SoluMedrol. Main objective is to assess the occurrence of new gadolinium-enhanced T1-weighted lesions at week 8 vs week 1 after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nanocort
PEG-liposomal prednisolone sodium phosphate (Nanocort) 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1
干预措施: PEG-liposomal prednisolone sodium phosphate (Drug)
Solu-Medrol
Methylprednisolone (Solu-Medrol) 1 g, IV, infusion over 2 hours on days 1, 2 and 3
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.
时间窗: 8 weeks
次要结局
- Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4.(4 weeks)
- Clinical response measured by changes in MSFC(12 weeks)
- Plasma levels of free prednisolone and prednisolone phosphate(12 weeks)
- Occurrence of adverse events(12 weeks)
- Quality of life measured by changes in MSIS-29(12 weeks)