Effects of Levetiracetam on Chronic Neuropathic Pain Following Spinal Cord Injury: a Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Change in median pain intensity (measured daily on a 10 point NRS) of spontaneous pain from baseline week to last week of treatment.
研究概览
简要总结
Purpose: To evaluate the efficacy and safety of levetiracetam on chronic neuropathic pain after spinal cord injury, and to examine its effect on spasms and evoked pain.
详细描述
Study design: Randomized double-blind cross-over study of levetiracetam (Keppra) against corresponding placebo with a 1 week baseline period followed by 2 x 5 weeks treatment periods separated by a 1 week wash-out period.
Methodology: Levetiracetam and corresponding placebo is gradually increased during two weeks from 500 mg x 2 daily to 1500 mg x 2 daily (1000 mg x 2 daily is allowed if 1500 mg x 2 is not tolerated), and kept on that dose for three weeks.
The study will be monitored by the GCP units of Aarhus and Copenhagen University.
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
- Double (Participant, Investigator)
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
- •age 18 or more
- •neuropathic pain (that have lasted at least 3 month) after a spinal cord injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale
排除标准
- •pregnancy or lactation
- •allergy to levetiracetam
- •alcohol or substance abuse, mental disease, epilepsy, depression and psychiatric disorders, severe liver disease, decreased kidney function, and known concomitant cerebral damage
研究组 & 干预措施
1
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Change in median pain intensity (measured daily on a 10 point NRS) of spontaneous pain from baseline week to last week of treatment.
时间窗: Last week of each 5-week treatment period
次要结局
- Spasms and spasticity; pain relief for total, at- and below-level pain; evoked pain; escape medication; NPSI; predictive value of the presence of evoked pain; Global impression of change; sleep disturbance.(Last day of each 5-week treatment period)