EUCTR2013-002558-64-IT进行中（未招募）1 期
A randomised, placebo-controlled trial investigating the role of fampiridina in improving cognitive function of patients with multiple sclerosis.
dipartimento di neurologia e psichiatria0 个研究点目标入组 123 人开始时间: 2013年10月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 123
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •age from 18 to 65 years (inclusive);
- •a cognitive impairment as defined as a score less than 10 percentile in at least one of the test used in the neuropsychological evaluation at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 123
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •clinical relapse occurred in the previous 60 days;
- •history of major depression or psychosis, according on Beck Depression Inventory-IA (cut-off 19);
- •history of seizures; any condition that would interfere with study conduction, introduction or modification of any medication for mood, fatigue or cognition in the previous month.
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