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临床试验/NCT00238511
NCT00238511已完成2 期

An Open-Label Follow-on Trial to Assess the Long-Term Safety and Efficacy of Oral SPM 927 in Subjects With Postherpetic Neuralgia (PHN)

UCB Pharma1 个研究点 分布在 1 个国家开始时间: 2002年11月最近更新:
适应症
相关药物

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

入选标准

  • Postherpetic Neuralgia

排除标准

  • Does not benefit from long term treatment

研究者

发起方
UCB Pharma
申办方类型
Industry

研究点 (1)

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