NCT03302806已完成不适用
Observational Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Evolution of post-treatment disability
研究概览
简要总结
The purpose of this observational study is to collect efficacy and safety data in real life condition within the first year of treatment in patients with progressive multiple receiving a daily dose of biotine of 300 mg.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Progressive multiple sclerosis patients with an EDSS score ≤ 7 who have been prescribed high dose of biotin (temporary use administration) at Nantes university hospital (France)
排除标准
- •Patient with remittent recurrent multiple sclerosis
- •Pregnant women or women contemplating pregnancy
结局指标
主要结局
Evolution of post-treatment disability
时间窗: 12 months
Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period
次要结局
- CGI-t scale(after 6 months and 12 months)
- Functional disability : Multiple sclerosis Functional composite(12 months)
- Ambulation(12 months)
- adverse effect (adverse drug reaction)(12 months)
- Quality of life(12 months)
研究者
研究点 (1)
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