NCT06091020已完成2 期
A Parallel-group Treatment, Proof-of-concept Phase 2, Multicenter, Double-blind, Randomized Two-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 to Severe Chronic Peripheral Neuropathic Pain Due to Postherpetic Neuralgia or Peripheral Nerve Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 62
- 主要终点
- Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12.
研究概览
简要总结
In this clinical trial, participants with nerve pain after shingles or nerve injury will receive injections with NT 201 or placebo. The purpose is to measure the decrease of nerve pain with NT 201 compared to placebo.
Trial details include:
- Trial duration: 22-23 weeks;
- Treatment duration: 1 injection visit with a 20-week follow-up period;
- Visit frequency: 2 remote visits by phone/video call (1 week and 12 weeks after the injection); 2 on-site visits (6 weeks and 20 weeks after the injection).
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
- Quadruple (Participant, Care Provider, 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
- •Chronic peripheral neuropathic pain 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 postherpetic neuralgia with at least probable level of certainty according to the NeuPSIG/IASP (Neuropathic Pain Special Interest Group / International Association on the Study of Pain) 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 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 amputation and/or phantom limb pain.
研究组 & 干预措施
NT 201
Experimental
Subcutaneous injections of up to 300 units NT 201 into the peripheral neuropathic pain area
干预措施: IncobotulinumtoxinA (Biological)
Placebo
Placebo Comparator
Subcutaneous injections of placebo into the peripheral neuropathic pain area
干预措施: Placebo (Biological)
结局指标
主要结局
Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12.
时间窗: Baseline to week 2 to 12
次要结局
- Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 2 to 12(Baseline to week 2 to 12)
- Incidence of treatment-emergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study.(Baseline to week 20)
研究者
研究点 (62)
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