NCT00423527已完成4 期
Double-blind, Randomised,Placebo-controlled Trial of Levetiracetam in Central Pain in Multiple Sclerosis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week of each period)
研究概览
简要总结
Multiple sclerosis is often associated with pain. There is no standard treatment of this type of pain. Levetiracetam is a new anticonvulsant and it is the hypothesis that it could relieve central pain in multiple sclerosis. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3000 mg daily on pain in multiple sclerosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •ms diagnosis verified
- •age > 18 years
- •central pain symptoms for more than 3 months
- •central pain diagnosis confirmed by neurological examination
- •adequate anticonceptive treatment for women with child bearing potential
- •informed consent
- •baseline pain of more than 4 on numeric rating scale
排除标准
- •other cause of pain
- •previous allergic reaction towards levetiracetam
- •known adverse drug reaction on levetiracetam
- •pregnancy
- •severe disease
- •inability to follow study protocol
- •treatment with antidepressants, other anticonvulsants or opioids
结局指标
主要结局
Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week of each period)
时间窗: Weekly
次要结局
- Pin-prick-evoked pain(Daily)
- Brush-evoked pain(Baseline and end of each treatment period)
- Pain subtypes rated on the same scale.(Daily)
- Pain rated on a 0 to 10 point numeric rating scale(Daily)
- Muscle spasms as measured on 2 different scales(Baseline and end of each treatment period)
- Use of escape medication(Daily)
- Cold-evoked pain(Daily)
- Health related quality of life (SF36)(Baseline and end of each treatment period)
- Pain related sleep disturbance(Daily)
研究者
研究点 (2)
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