CTIS2022-501461-52-00招募中1 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. - M602011079
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+(—)
- 性别
- All
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 2., 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.
研究者
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