NCT00286260已完成4 期
Double-blind, Randomised, Placebo-controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 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 in each period)
研究概览
简要总结
Polyneuropathy of different etiologies is often associated with pain. The standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000 mg/day on pain in polyneuropathy
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20 to 0 years
- •painful symptoms of polyneuropathy for at least 6 months
- •confirmed diagnosis of polyneuropathy
- •baseline pain score of 4 or more (0 to 10 point scale)
- •pain at least 4 days a week
- •adequate anticonceptive treatment for women with childbearing potential
- •informed consent
排除标准
- •other cause of pain
- •previous allergic reactions towards levetiracetam
- •known adverse drug reactions 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 in each period)
时间窗: Daily
次要结局
- Pain rated on 0 to 10 point numeric rating scales(Daily)
- Cold evoked pain(Baseline and end of each treatment period)
- Health related quality of life(SF-36)(Baseline and end of each treatment period)
- Pain subtypes rated on 0 to 10 point numeric rating scales(Daily)
- Pin-prick evoked pain(Baseline and end of each treatment period)
- Bruch-evoked pain(Baseline and end of each treament period)
- Pain related sleep disturbance(Daily)
- Use of escape medication(Daily)
研究者
研究点 (2)
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