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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTX-001 | Experimental | NTX-001 used during the surgical repair of an upper extremity peripheral nerve injury in conjunction with standard suture neurorrhaphy. |
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| Standard Suture Neurorrhaphy | No Intervention | Standard of Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTX-001 (PEG-Fusion) | Combination Product | One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain) | 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. | Screening Visit, Week 24 |
| Safety - Columbia-Suicide Severity Rating Scale | 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. | Screening Visit, Weeks 4, 12, and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative CheckPoint® Stimulation. | A CheckPoint® Stimulator will be used intra-operatively to detect immediate reconnection of severed peripheral nerves (axons) in mixed-motor nerves only. The measures include in response of direct nerve stimulation, proximally and distally to suture site. | In Operating Room |
| Measure | Description | Time Frame |
|---|---|---|
| Electromyography (EMG) Testing | EMG will be used to detect reconnection of severed peripheral nerves (axons) using PEG Fusion. Restoration of nerve conduction indicates the restoration of axon continuity, which is a prerequisite for the prevention of Wallerian degeneration, neuromuscular junction degeneration, muscle atrophy and functional recovery. This testing will be done at select clinical sites. | Weeks 12, 24. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seth Schulman, MD | Contact | 215-206-9504 | seth.schulman@neuraptive.com | |
| Kristen Olszyk, MS | Contact | 484-753-1205 | kristen.olszyk@neuraptive.com |
| Name | Affiliation | Role |
|---|---|---|
| Seth Schulman, MD | Neuraptive Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Not yet recruiting | Los Angeles | California | 90048 | United States |
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| Label | URL |
|---|---|
| Sponsor Website | View source |
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Treatment vs. Standard of Care
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All study personnel involved in the surgical procedure will be unblinded. Patient, Care Providers and outcomes evaluators will be blinded.
| MHQ Total Score |
The MHQ quantifies different impairments between the subjects in uninjured and involved upper extremities. A general survey of hand function includes twenty-five items for the right and the left hand, as well as questions for both hands. Questions regarding function specifically refer to the impact of the involved hand and/or wrist on the activity which presumably takes all joints of the upper extremity into account. The overall questionnaire is scored from 0 to 100, with 100 being the optimal score. |
| Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48 |
| Time to Return to Function | Achievement of seventy-five (75)% function in the combined ADL and pain MHQ domain scores. The Activities of Daily Living component evaluates the ability to perform specific tasks using either hand or both hands together. The Pain subdomain addresses the frequency and intensity of pain in both the right and left hands/wrists, along with its impact on sleep and daily activities, and the emotional distress it causes. The overall questionnaire is scored from 0 to 100, with 100 being the optimal score. | Screening Visit, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48. |
| Change in NPRS | The NPRS is used to assess for pain and to determine pain intensity. The NPRS is an 11-point scale scored from 0-10: 1) "0" = no pain 2) "10" = the most intense pain imaginable. The average of the 3 ratings is used to represent the subject's level of pain over the previous 24 hours. | Screening Visit, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 30, 36, 42, and 48 |
| Semmes Weinstein Monofilament Test (SWMT) | SWMT provides information on protective sensation, the rigorous system can detect relatively minor differences in sensory function, and changes will occur early in nerve injury. The assessment tool consists of a set of monofilaments that vary in thickness and diameter, the gradient forces of these monofilaments that subjects' can feel, range from 0.086 gm to 0.448gm. The normal value in the hand is in the range of the green filament (1.65 to 2.83 mN). | Weeks 2, 4, 8, 12, 24, 36, 48. |
| MHQ Two Domain Score | The Activities of Daily Living component evaluates the ability to perform specific tasks using either hand or both hands together. The Pain subdomain addresses the frequency and intensity of pain in both the right and left hands/wrists, along with its impact on sleep and daily activities, and the emotional distress it causes. The raw scale score for each of the 6 scales is the sum of the responses of each scale item. The raw score is converted to a score range from 0 to 100. 100 being the best. | Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, 48 |
| Change from Week 2 in MHQ Two Domain Score | The Activities of Daily Living component evaluates the ability to perform specific tasks using either hand or both hands together. The Pain subdomain addresses the frequency and intensity of pain in both the right and left hands/wrists, along with its impact on sleep and daily activities, and the emotional distress it causes. The raw scale score for each of the 6 scales is the sum of the responses of each scale item. The raw score is converted to a score range from 0 to 100. 100 being the best. | Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48. |
| Medical Research Council Classification (MRCC) Sensory Score | The scale is commonly used including 2 Point Discrimination for grading the sensory outcome after peripheral nerve surgery. This scale is categorized into S0-S4: S0 is the absence of sensibility; S1 is the recovery of deep cutaneous pain; S2 is the return of superficial cutaneous pain and some degree of tactile sensibility; S3 is the return of superficial cutaneous pain and tactile sensibility without over response; and S4 is the complete recovery. | Weeks 2, 4, 8, 12, 24, 36, and 48. |
| Medical Research Council Classification (MRCC) Motor Score | This assessment is conducted on mixed motor nerve injuries only. Strength can best be assessed by isolating an individual muscle group and comparing power with that of the subject. It can be conducted to assess larger muscles or muscle groups as well as intrinsic muscles of the hand. Measuring the difference between the affected limb and the contralateral limb. 0/5 is no muscle activation whatsoever; 1/5 is muscle activation without limb movement; 2/5 implies that the limb can be moved only when gravity is taken out of the equation; 3/5 means that the subject can overcome gravity but not resistance;• 4/5 (or 4+ or 4-) implies weakness with enough strength to overcome varying degrees of physical resistance; 5/5 is full strength. | Weeks 2, 4, 8, 12, 24, 36, 48 |
| Change from Baseline (W2) in Numeric Pain Rating Scale (NPRS) | The NPRS is used to assess for pain and to determine pain intensity. The NPRS is an 11-point scale scored from 0-10: 1) "0" = no pain 2) "10" = the most intense pain imaginable. The average of the 3 ratings is used to represent the subject's level of pain over the previous 24 hours. | Weeks 2, 24. |
| Patient Global Impression of Change Score | This scale evaluates all aspects of patients; health and assesses if there has been an improvement or decline in clinical status. PGIC is a 7-point scale depicting a subjects rating of overall improvement. The subject rates their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." | Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, and 48 |
| Change in Total MHQ Score | The MHQ quantifies different impairments between the subjects uninjured and involved upper extremities. It was designed as a general survey of hand function and includes twenty-five items for the right and the left hand, as well as questions for both hands. Furthermore, questions regarding function specifically refer to the impact of the involved hand and/or wrist on the activity which presumably takes all joints of the upper extremity into account. The overall questionnaire is scored from 0 to 100, with 100 being the optimal 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) | The PGIS is a single question asking the subject to rate the severity of the injury from the last visit. PGIS is a scale depicting a subject's rating of overall severity. The subject scores their perception of severity as "none," "mild," "moderate," "severe," or "very severe." | Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42 and 48. |
| Nerve Conduction Velocity (NCV) | NVC testing measures how fast an electrical impulse moves through a nerve. This testing will be done at select clinical sites. | Weeks 12, 24 |
| Physical and Occupational Therapy | Each subject will have the number of times physical therapy and/or occupational therapy is prescribed to determine if this activity affects the sensory and functional outcomes of the nerve repair between NTX-001 and SOC. | Weeks 2, 4, 8, 12, 24, 36, and 48. |
| Rothman Orthopedics - Advent Health | Recruiting | Orlando | Florida | 32804 | United States |
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| Orlando Health Orlando Regional Medical Center | Recruiting | Orlando | Florida | 32806 | United States |
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| Grady Health | Recruiting | Atlanta | Georgia | 30303 | United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| University of Louisville | Not yet recruiting | Louisville | Kentucky | 40202 | United States |
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| Louisiana State University Health Sciences Center | Recruiting | New Orleans | Louisiana | 70112 | United States |
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| Curtis National Center at MedStar Union Memorial Hospital | Recruiting | Baltimore | Maryland | 21218 | United States |
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| Missouri Orthopaedic Institute | Recruiting | Columbia | Missouri | 65211 | United States |
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| Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St. | Recruiting | St Louis | Missouri | 63110 | United States |
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| The Cooper Health System | Recruiting | Camden | New Jersey | 08103 | United States |
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| NYU Langone Health | Recruiting | New York | New York | 10003 | United States |
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| UC Health | Recruiting | Cincinnati | Ohio | 45267 | United States |
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| University of Cincinnati Health | Recruiting | Cincinnati | Ohio | 45267 | United States |
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| The MetroHealth System | Recruiting | Cleveland | Ohio | 44109 | United States |
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| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43212 | United States |
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| University of Pennsylvania, Department of Orthopaedic Surgery | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Allegheny Health Network | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29429 | United States |
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| Baylor, Scott and White Health | Recruiting | Dallas | Texas | 75246 | United States |
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| Texas Tech | Recruiting | Lubbock | Texas | 79415 | United States |
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| University of Utah Health | Not yet recruiting | Salt Lake City | Utah | 84132 | United States |
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| UVA Health | Recruiting | Charlottesville | Virginia | 22903 | United States |
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| Harborview Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
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| ID | Term |
|---|---|
| D059348 | Peripheral Nerve Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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