NCT00861068已完成2 期
A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Pilot Trial to Assess the Efficacy, Safety, and Tolerability of SPM 927 in Subjects With Postherpetic Neuralgia (PHN).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 44
- 主要终点
- Within-subject change in average daily pain score (Likert categorical scale) from the baseline week to the maintenance phase
研究概览
简要总结
The objective of the trial is to investigate the analgesic efficacy of SPM 927 in subjects with moderate to severe neuropathic pain due to Postherpetic Neuralgia (PHN)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Subject has clinically diagnosed painful postherpetic neuralgia present at least six months after healing of a herpes zoster skin rash and has at least one form of allodynia
- •Subject must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
排除标准
- •Subject has other conditions that cause pain at least as severe as the postherpetic neuralgia.
- •Subject has had any surgical treatment or any neurolytic injections for PHN
- •Subject has clinically significant ECG and laboratory abnormalities.
- •Subject is receiving treatment with anti-epileptic drugs (AEDs), muscle relaxants, mexiletine, topical analgesics, antidepressants, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, benzodiazepines, and antiviral agents.
- •Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin and GGT out of the reference range) > 1,5 x ULN (upper limit of normal) at visit 1
- •Subject has serum creatinine ≥ 2 times the upper limit of reference range at Visit 1.
研究组 & 干预措施
1
Experimental
干预措施: SPM927/Lacosamide (Drug)
2
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Within-subject change in average daily pain score (Likert categorical scale) from the baseline week to the maintenance phase
时间窗: Daily Assessments via patient diary and during patient's visit at the site
次要结局
- Different qualities of pain due to PHN, sleep and activity (daily assessment during entire trial participation)(Daily assessment during entire trial participation including visits at the site)
- Investigate the tolerability and safety of SPM927 (assessments and reporting during entire trial participation).(Daily assessment during entire trial participation including visits at the site)
- To examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)(Daily assessment during entire trial participation including visits at the site)
研究者
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