2022-501461-52-00招募中2 期
A parallel-group treatment, proof-of-concept Phase 2, multicenter, double-blind, randomized 2 arm clinical trial to investigate the efficacy and safety of subcutaneous NT 201 injections compared with placebo injections in decreasing pain intensity in male and female participants aged 18 years and older with moderate or severe chronic neuropathic pain due to postherpetic neuralgia or peripheral nerve injury.
Merz Therapeutics GmbH, Merz Therapeutics GmbH24 个研究点 分布在 6 个国家目标入组 120 人开始时间: 2023年4月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 24
- 主要终点
- Weekly averages of changes from baseline in ADP intensity at Weeks 2 to 12.
研究概览
简要总结
To establish evidence of efficacy of NT 201 in the treatment of moderate to severe chronic PNP in patients with postherpetic neuralgia or chronic neuropathic pain after peripheral nerve injury by demonstrating superiority compared to placebo in reducing Average Daily Pain (ADP) intensity.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment and Follow-Up Period
- 盲法
- Double (Analyst, Monitor, Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Chronic PNP that persists for at least 6 months by the time of the screening visit and is plausibly related to either an episode of herpes zoster or a peripheral nerve injury (caused by surgery or mechanical trauma).
- •Documented diagnosis of either chronic neuropathic pain after peripheral nerve injury (i.e., postsurgical/post-traumatic neuropathic pain) or PHN with at least probable level of certainty according to the NeuPSIG/IASP grading system.
- •A score of at least 4 out of 10 points on the Neuropathic Pain 4 Questions (DN4) questionnaire.
排除标准
- •Complex Regional Pain Syndrome Type 1 and Type
- •Any other painful condition or disease that requires regular treatment (only mild to moderate episodic migraine treated with triptans and/or non-steroidal anti-inflammatory drugs (NSAIDs), if any, is acceptable).
- •Postsurgical/post-traumatic neuropathic pain due to limb amputation and/or phantom limb pain.
结局指标
主要结局
Weekly averages of changes from baseline in ADP intensity at Weeks 2 to 12.
Weekly averages of changes from baseline in ADP intensity at Weeks 2 to 12.
次要结局
- Changes from baseline in NPSI total score at Weeks 2 to 12.
- Incidence of treatmentemergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study.
研究者
Contact Point Clinical Trials
Scientific
Merz Therapeutics GmbH
研究点 (24)
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