Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care (Neurorrhaphy) in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 27
- 主要终点
- Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain)
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 18 and 80.
详细描述
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, Care Providers and outcomes evaluators will be blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form.
- •The subject is between eighteen (18) and eighty (80) years of age.
- •The subject has clinical evidence of a Sunderland's 4th degree (Class II) or 5th degree (Class III) nerve transection(s) that has resulted in upper extremity nerve impairment that requires surgical treatment.
排除标准
- •Subjects whose nerve repair will occur greater than 48 hours after nerve transection.
- •Subjects requiring nerve repair involving an autograft, allograft or conduit(s).
- •Subjects with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair.
- •Subjects who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow up due to significant muscle atrophy or other morbidity.
- •The subject's injury is a result of a suicide attempt or self- harm.
- •The subject has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system).
- •The subject has a known allergy to polyethylene glycol (PEG) or human grade silicone.
- •The subject is pregnant or breastfeeding.
- •The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.
研究组 & 干预措施
Standard Suture Neurorrhaphy
Standard of Care
NTX-001
NTX-001 used during the surgical repair of an upper extremity peripheral nerve injury in conjunction with standard suture neurorrhaphy.
干预措施: NTX-001 (PEG-Fusion) (Combination Product)
结局指标
主要结局
Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain)
时间窗: Screening Visit, Week 24
The subject will complete the MHQ questionnaire at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48. A measure of the mean of MHQ in the Two Domains, Activities of Daily Living and Pain Scores, at Week 24 in the NTX-001 group as compared to Standard of Care (SoC). In the ADL subdomain, a higher component score indicates better function. In the Pain subdomain, a higher component score indicates greater pain. A total MHQ score of 100 is considered the best functional score.
Safety - Columbia-Suicide Severity Rating Scale
时间窗: Screening Visit, Weeks 4, 12, and 48
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a suicide risk assessment tool. The C-SSRS tool asks; whether and when the subject has had a thought about suicide (ideation); what actions they might have taken and what they did to prepare for suicide; whether and when they attempted suicide or began a suicide attempt that was either interrupted by another person or stopped of their own volition. The answers identify whether someone is at risk for suicide, assessing the severity and immediacy of that risk, and gauging the level of support that the person needs. The first assessment is done by study staff at screening. Subsequent assessments will be completed by the subject at Weeks 4, 12, and 48. A score of 0 indicates no risk, 1-2 indicates low risk, and 3+ indicates moderate to high risk.
次要结局
- Electromyography (EMG) Testing(Weeks 12, 24.)
- Nerve Conduction Velocity (NCV)(Weeks 12, 24)
- Intraoperative CheckPoint® Stimulation.(In Operating Room)
- MHQ Total Score(Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48)
- Time to Return to Function(Screening Visit, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.)
- Change in NPRS(Screening Visit, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 30, 36, 42, and 48)
- Semmes Weinstein Monofilament Test (SWMT)(Weeks 2, 4, 8, 12, 24, 36, 48.)
- MHQ Two Domain Score(Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, 48)
- Change from Week 2 in MHQ Two Domain Score(Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.)
- Medical Research Council Classification (MRCC) Sensory Score(Weeks 2, 4, 8, 12, 24, 36, and 48.)
- Medical Research Council Classification (MRCC) Motor Score(Weeks 2, 4, 8, 12, 24, 36, 48)
- Columbia-Suicide Severity Rating Scale(Screening Visit, Weeks 4, 12 and 48)
- Change from Baseline (W2) in Numeric Pain Rating Scale (NPRS)(Weeks 2, 24.)
- Patient Global Impression of Change Score(Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, and 48)
- Change in Total MHQ Score(Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.)
- Patient Global Impression of Change Score (PGIC)(Week 24)
- MHQ Total Score(Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48)
- MHQ Two Domain Score(Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, 48)
- Change in Total MHQ Score(Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.)
- Change from Baseline in Patient Global Impression of Severity Score (PGIS)(Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42 and 48.)