This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.

July 30, 2026 updated by: Neuraptive Therapeutics Inc.

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Not yet recruiting
        • Cedars Sinai Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meghan C McCullough, MD
    • Florida
      • Orlando, Florida, United States, 32806
      • Orlando, Florida, United States, 32804
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicole A Zelenski, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeffrey Stepan, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tuna Ozyurekoglu, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Louisiana State University Health Sciences Center
        • Principal Investigator:
          • Harvey Chim, MD, FACS
        • Contact:
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Curtis National Center at MedStar Union Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kenneth R Means Jr., MD
    • Missouri
      • Columbia, Missouri, United States, 65211
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.
        • Contact:
        • Principal Investigator:
          • David M Brogan, MD, MSc
        • Contact:
    • New Jersey
      • Camden, New Jersey, United States, 08103
    • New York
      • New York, New York, United States, 10003
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • UC Health
        • Principal Investigator:
          • Sonu Jain, MD
        • Contact:
        • Contact:
          • Brittany Rowley, CCRC Clinical Research Professional III
          • Phone Number: 513-558-2765
          • Email: rowleybm@ucmail.uc.edu
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati Health
        • Principal Investigator:
          • Sonu Jain, MD
        • Contact:
        • Contact:
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • The MetroHealth System
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kyle Chepla, MD
      • Columbus, Ohio, United States, 43212
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ryan Schmucker, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania, Department of Orthopaedic Surgery
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ines C Lin, MD
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network
        • Contact:
        • Contact:
          • Mary Fetter - Lead Clinical Research Coordinator
          • Phone Number: 412-359-8292
          • Email: Mary.Fetter@ahn.org
        • Principal Investigator:
          • Steven Regal, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29429
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Contact:
        • Principal Investigator:
          • Charles Daly, MD
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor, Scott and White Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Asadullah Helal, MD
      • Lubbock, Texas, United States, 79415
        • Recruiting
        • Texas Tech
        • Principal Investigator:
          • Brendan MacKay, MD
        • Contact:
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Not yet recruiting
        • University of Utah Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark Mahan, MD, FAANS
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • UVA Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Brett DeGeorge, MD
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Harborview Medical Center
        • Contact:
        • Contact:
          • Yusha ( Katie) Liu, MD PhD
          • Phone Number: 206-744-3000
          • Email: HMCnerve@uw.edu
        • Principal Investigator:
          • Katie Liu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Suture Neurorrhaphy
Standard of Care
Experimental: NTX-001
NTX-001 used during the surgical repair of an upper extremity peripheral nerve injury in conjunction with standard suture neurorrhaphy.
Combination product: NTX-001 (PEG-Fusion)
One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain)
Time Frame: 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.
Screening Visit, Week 24
Safety - Columbia-Suicide Severity Rating Scale
Time Frame: 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.
Screening Visit, Weeks 4, 12, and 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative CheckPoint® Stimulation.
Time Frame: In Operating Room
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
Time to Return to Function
Time Frame: Screening Visit, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.
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
Time Frame: Screening Visit, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 30, 36, 42, and 48
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)
Time Frame: Weeks 2, 4, 8, 12, 24, 36, 48.
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.
Change from Week 2 in MHQ Two Domain Score
Time Frame: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.
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
Time Frame: Weeks 2, 4, 8, 12, 24, 36, and 48.
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
Time Frame: Weeks 2, 4, 8, 12, 24, 36, 48
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)
Time Frame: Weeks 2, 24.
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
Time Frame: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, and 48
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
MHQ Total Score
Time Frame: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48
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
MHQ Two Domain Score
Time Frame: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, 48
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 in Total MHQ Score
Time Frame: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.
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)
Time Frame: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42 and 48.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyography (EMG) Testing
Time Frame: Weeks 12, 24.
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.
Nerve Conduction Velocity (NCV)
Time Frame: Weeks 12, 24
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
Time Frame: Weeks 2, 4, 8, 12, 24, 36, and 48.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuraptive Therapeutics Inc.

Investigators

  • Study Director: Seth Schulman, MD, Neuraptive Therapeutics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTx24301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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