Phase 2a, Multicenter, Randomized, Patient and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to SOC in the Treatment of Acute Single Transected Peripheral Nerve Injury Occurring Below the Distal Border of the Brachial Plexus Requiring Surgical Repair.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 20
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
研究概览
简要总结
NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 16 and 80 years of age.
详细描述
NTX-001 (Product) is a surgical product that consists of an active solution (drug), an isolation chamber medical device (chamber or device) and two (2) other sterile solutions.
NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves. It often takes months and/or years to determine if function will be restored. By that point, restoration is often incomplete and can result in lifelong motor and/or sensory deficits. By reconnecting (PEG-fusion) a substantial number of axons within a severed nerve, the degeneration-regeneration cycle and subsequent atrophy may be reduced or even prevented for those axons and their targets, respectively. NTX-001 (PEG-fusion) has the potential to avoid the consequences of protracted denervation of distal target tissues by eliminating the period of total denervation thus reducing the time to stable recovery and providing greater innervation to affected tissues.
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, Care Provider, Outcomes Assessor)
盲法说明
All study personnel involved in the surgical procedure will be unblinded. Patient and outcomes evaluators will be blinded.
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is at least 12 years of age and not older than
- •The subject has sustained a confirmed (intra-op assessment) single transected peripheral nerve injury.
- •The subject's nerve injury is classified as Sunderland's Fourth and Fifth Degree (Class III)
- •The subject's nerve injury is amenable to minimal or acceptable tension, in direct, end-to-end repair.
- •The surgical repair will occur within 48 hours of injury.
排除标准
- •The subject has a PNI with a segmental loss (gap) that cannot be repaired with minimal or acceptable tension.
- •Other treatments known to affect the growth and/or physiology of the neural and vascular system.
- •The nerve injury has vascular damage that cannot be repaired to provide adequate perfusion of the injured site.
- •The subject is pregnant and/or is breastfeeding.
- •The subject has a significant medical comorbidity precluding immediate repair.
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
时间窗: Up to 48 Weeks
An adverse event is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a study product or in a clinical study. A treatment-emergent adverse event was defined as any adverse event that newly appeared, increased in frequency, or worsened in severity on or after the exposure to the study product.
Michigan Hand Questionnaire Total Score (MHQ)
时间窗: Week 12
The MHQ measures hand function and is scored from 0-100; with 100 being the "best" score.
次要结局
- Modified British Medical Research Council (MMRC) motor grading (M0-M5)(Weeks 4, 8, 12, 24, 36 and 48)
- Grip Strength(Weeks 4, 8, 12, 24, 36 and 48)
- Numeric Pain Rating Scale (NPRS)(Weeks 4, 8, 12, 24, 36 and 48)
- Modified British Medical Research Council (MMRC) sensory grading (S0-S4)(Weeks 4, 8, 12, 24, 36 and 48)
- Pinch Strength(Weeks 4, 8, 12, 24, 36 and 48)
- Patient Global Impression of Change (PGIC)(Weeks 4, 8, 12, 24 and 48)
- Semmes-Weinstein Monofilament Test (SWMT)(Weeks 4, 8, 12, 24, 36 and 48)
- Cold Intolerance Symptom Severity (CISS)(Weeks 4, 8, 12, 24 and 48)