NCT00984984Unknown3 期
Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses
Rennes University Hospital14 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- At least 1 point-reduction on Kurtzke functional scale
研究概览
简要总结
The efficacy of oral corticosteroids for the treatment of relapses of multiple sclerosis has not been proved. French neurologists treat such patients with intravenous corticosteroids. The aim of the study is to check if the efficacy of high dose oral methylprednisolone is similar to the efficacy intravenous (IV) prednisolone. The main criteria of efficacy is symptom recovery within 28 days after inclusion.
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
- Triple (Participant, Care Provider, 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
- •age 18 to 55
- •informed written consent
- •multiple sclerosis (Mc Donald criteria, relapsing-remitting
- •EDSS before relapse : 0 to 5
- •relapse : increase of 1 point or more for 1 or more functional systems of Kurtzke, with SF score most affected > 1 for all functions except for sensory (> 2); duration of symptoms > 24 h
排除标准
- •previous relapse, and/or corticosteroid treatment < 1 month before present relapse
- •first symptoms of the present relapse appeared > 15 days before inclusion
- •under mitoxantrone of cyclophosphamid or natalizumab treatment
- •infection not under control
- •liver or kidney failure
- •psychiatric symptoms not under control
- •pregnancy
- •hypersensibility to methylprednisolone
研究组 & 干预措施
methylprednisolone PO
Experimental
干预措施: methylprednisolone PO (Drug)
methylprednisolone IV
Active Comparator
干预措施: methylprednisolone IV (Drug)
结局指标
主要结局
At least 1 point-reduction on Kurtzke functional scale
时间窗: 28 days after beginning of corticotherapy
次要结局
未报告次要终点
研究者
研究点 (14)
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