NCT00736151已完成2 期
A Phase II, Multicentre, Pilot, Randomised, Double Blind Placebo Controlled Dose Titration Study to Evaluate the Safety, Maximum Tolerated Dose and Preliminary Evidence of Efficacy of Orally Administered Ralfinamide at Four Doses (80, 160, 240 and 320 mg/Day) in Patients With Neuropathic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 46
- 主要终点
- Change of pain intensity
研究概览
简要总结
The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients
- •Females post-menopausal for at least 12 months, 24 months in India, Poland, and Austria
- •Diagnosed by neurologist with current neuropathic pain
排除标准
- •See inclusion criteria
研究组 & 干预措施
1
Experimental
Ralfinamide administered orally at rising doses of 80 - 320 mg/day
干预措施: Ralfinamide (Drug)
2
Active Comparator
Placebo controlled with randomization of 2:1
干预措施: Ralfinamide (Drug)
结局指标
主要结局
Change of pain intensity
时间窗: Baseline to week 8 or last visit
次要结局
- The incidence of adverse events(From baseline to week 8 or last visit)
研究者
研究点 (46)
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