An Open-Label Follow-on Trial to Assess the Long-Term Safety and Efficacy of Oral SPM 927 in Subjects With Postherpetic Neuralgia (PHN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 试验地点
- 1
研究概览
简要总结
This trial was the follow-on trial to a preceeding double-blind, placebo controlled trial which included patients with at least moderate pain due to postherpetic neuralgia. It was conducted at six sites in Germany and has been clinically finalized. The patients had successfully completed the above mentioned trial in postherpetic neuralgia and, in the investigator's opinion, would benefit from long-term administration of Lacosamide. After a 1-week run-in phase the patients were uptitrated to their optimal dose and then continued into the maintenance phase. Dose adjustments were allowed throughout the trial.The change in pain was measured daily as well as interference of pain with sleep and general activity. As per protocol this trial was terminated after two years of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Postherpetic Neuralgia
排除标准
- •Does not benefit from long term treatment
