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

NCT06616025 | Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: NTx24301
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Peripheral Nerve Injury (PNI); Peripheral Nerve Injury Upper Limb

Keywords

Transected Nerves; Requiring Surgical Repair; Upper Extremity

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (13)

• Intraoperative CheckPoint® Stimulation.

  In Operating Room

• MHQ Total Score

  Screening Visit; 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.

Other Outcomes (3)

• Electromyography (EMG) Testing

  Weeks 12, 24.

• Nerve Conduction Velocity (NCV)

  Weeks 12, 24

• Physical and Occupational Therapy

  Weeks 2, 4, 8, 12, 24, 36, and 48.

Study Arms (2)

NTX-001

EXPERIMENTAL

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)

Standard Suture Neurorrhaphy

NO INTERVENTION

Standard of Care

Interventions

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.

NTX-001

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuraptive Therapeutics Inc.: lead

Study Sites (12)

Orlando Health Orlando Regional Medical Center

Orlando, Florida, 32806, United States

RECRUITING

Grady Health

Atlanta, Georgia, 30303, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Curtis National Center at MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

RECRUITING

Missouri Orthopaedic Institute

Columbia, Missouri, 65211, United States

RECRUITING

Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.

St Louis, Missouri, 63110, United States

RECRUITING

NYU Langone Health

New York, New York, 10003, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43212, United States

RECRUITING

University of Pennsylvania, Department of Orthopaedic Surgery

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29429, United States

RECRUITING

UVA Health

Charlottesville, Virginia, 22903, United States

RECRUITING

Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

Related Links

• Sponsor Website

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Seth Schulman, MD

  Neuraptive Therapeutics Inc.

  STUDY DIRECTOR

Central Study Contacts

Seth Schulman, MD

CONTACT

215-206-9504; seth.schulman@neuraptive.com

Kristen Olszyk, MS

CONTACT

484-753-1205; kristen.olszyk@neuraptive.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All study personnel involved in the surgical procedure will be unblinded. Patient, Care Providers and outcomes evaluators will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment vs. Standard of Care

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 27, 2024
• Study Start: February 10, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-03

Locations

US (12)