Neuraptive
Brief description of study
This study will be a randomized, subject and evaluator blinded, controlled, multicenter trial conducted to evaluate the safety and efficacy NTX-001 compared to standard of care (neurorrhaphy) in the treatment of upper extremity transected nerves requiring surgical repair. The study will be conducted in approximately 25-30 sites in the US and will enroll approximately one hundred ten (110) subjects to meet the goal of ninety-eight (98) evaluable subjects. Subjects will be randomized in equal numbers to receive either standard of care or NTX-001. Each subject will be in the study for 48 weeks after receiving one treatment (IP or Standard of Care) during surgery.
Subjects presenting with a suspected nerve injury in the upper extremities that can undergo surgical repair within 48 hours of the injury occurring will be consented for the study. During surgical evaluation, subjects with a single (or multiple) transected motor/mixed-motor nerve(s) or a single (or multiple) transected sensory nerve(s) that can be repaired end-to-end will be randomized to a treatment arm. Specifically, if a potential subject has multiple digital nerves all must be amenable to direct repair, and all qualifying nerves will be included in the study. If randomized to NTX-001 each nerve will require a separate NTX-001 kit. Per exclusion criterion 2a, if multiple nerves are transected, a subject cannot enroll unless all are amenable to direct repair.
Detailed description of study
The main purposes of this study are to 1) see how safe NTX-001 is when used in nerve repair and, 2) see if your nerve becomes functional in a shorter period of time when compared to what is normally done to treat nerve injuries. NTX-001 is in an early stage of development for use in humans.
Your participation in the study will last 12 months including your time in hospital for the nerve repair. You will be randomly (like flipping a coin) entered into either the NTX-001 or Standard of Care group. The Standard of Care group receives the type of treatment that people with your type of injury usually receive. The cut nerve is sewn or stitched together in the operating room after you are seen in the emergency department. You will have a 50% chance of getting into either group. You will not know if you are in the NTX-001 group or standard of care group.
The various tests and procedures you will receive while in the study are described below:
1. C-SSRS-Columbia-Suicide Severity Rating Scale
2.Vital Signs, Medical History & Physical Exam
3. Blood Tests
4. Michigan Hand Questionnaire (MHQ) for general hand function assessment
5. MRCC Scale - Sensory and Muscle
6. Semmes Weinstein Monofilament Test
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Clinical Trial Research
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Age: 18 years - 80 years
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Gender: All
Inclusion Criteria
1. The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form.
2. The subject is between eighteen (18) and eighty (80) years of age.
3. 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.
a. 4th Degree (Class II) injuries are allowed if all axons/fascicles are assessed as fully transected in the operating room prior to randomization.
Exclusion Criteria
1. Subjects whose nerve repair will occur greater than 48 hours after nerve transection.
2. Subjects requiring nerve repair involving an autograft, allograft, or conduit(s).
a. Subjects with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair.
b. Subject presents with separate injuries to a nerve innervating the same area.
3. 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.
4. The subject’s injury is a result of a suicide attempt or self-harm.
5. 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).
6. The subject has a known allergy to polyethylene glycol (PEG) or human grade silicone.
7. The subject is pregnant or breastfeeding.
8. The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.
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