Multicentric Study, Comparative, Randomized, in Double Knowledge of the Effectiveness (Versus Placebo) of a Salt Of 3,4 - Diaminopyridine in the Treatment of Tiredness During the Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 4
- 主要终点
- improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
研究概览
简要总结
Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in patient's multiple sclerosis.
In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded study is performed.
详细描述
We proposed a randomized controlled trial between 3,4-diaminopyridine and placebo .
The main objective : improvement of fatigue by diminution of EMIF-SEP score between the arm treatment and placebo arm. The hypothesis tested is that the 3,4-DAP is efficacy in the fatigue of multiple sclerosis.
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
- Double (Participant, Investigator)
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
- •Age >= 18 years and = <60 years
- •Patients with multiple sclerosis clinically defined and with MIFS-SEP score > 44, without deficit sleep and without depression.
- •Patients without treatment by 3,4-DAP since 3 months
- •EDSS score < 6
排除标准
- •ASAT/ALAT > 2 x ULN
- •MADRS >= 20
- •Abnormality cardiac rhythm
- •Pregnancy
- •Evolutive affection
- •Renal failure
研究组 & 干预措施
3,4-diaminopyridine
3,4-diaminopyridine
干预措施: 3,4-diaminopyridine (Drug)
结局指标
主要结局
improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
时间窗: 43 months
improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
次要结局
- evaluation of safety(43 months)
- quality of life impact(43 months)