NCT00166452已完成3 期
Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidamide in the Treatment of Complex Regional Pain Syndrome Type1
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline
研究概览
简要总结
The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).
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
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 > or = to 18 years
- •Signed consent form
- •A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb
- •CRPS pain intensity score at least 4 on an 11-point PI-NRS
- •Measurable sural, median sensory, median motor and peroneal motor nerve conductions
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting the study drug. They must agree to use adequate contraceptive methods not including steroid-based contraceptives. They must also agree to have pregnancy tests every 4 weeks while on the study drug.
排除标准
- 未提供
结局指标
主要结局
RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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