Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries

NCT04572906 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: NTx20201
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 10

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 16 and 80 years of age.

Conditions

Peripheral Nerve Injuries

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

  An adverse event is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a study product or in a clinical study. A treatment-emergent adverse event was defined as any adverse event that newly appeared, increased in frequency, or worsened in severity on or after the exposure to the study product.

  Up to 48 Weeks

• Michigan Hand Questionnaire Total Score (MHQ)

  The MHQ measures hand function and is scored from 0-100; with 100 being the "best" score.

  Week 12

Secondary Outcomes (8)

• Numeric Pain Rating Scale (NPRS)

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

• Modified British Medical Research Council (MMRC) sensory grading (S0-S4)

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

• Modified British Medical Research Council (MMRC) motor grading (M0-M5)

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

• Semmes-Weinstein Monofilament Test (SWMT)

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

• Pinch Strength

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

Study Arms (2)

NTX-001

EXPERIMENTAL

NTX-001 used during surgical repair of an upper extremity peripheral nerve injury in conjuction with standard suture neurorrhaphy.

Combination Product: NTX-001

Standard of Care

NO INTERVENTION

standard suture neurorrhaphy

Interventions

NTX-001 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. An isolation chamber medical device (device) is utilized to focus the application of PEG (Solution #2) on the coapted nerve for the required amount of exposure time.

Also known as: PEG-fusion

NTX-001

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is at least 12 years of age and not older than 80.
• The subject has sustained a confirmed (intra-op assessment) single transected peripheral nerve injury.
• The subject's nerve injury is classified as Sunderland's Fourth and Fifth Degree (Class III)
• The subject's nerve injury is amenable to minimal or acceptable tension, in direct, end-to-end repair.
• The surgical repair will occur within 48 hours of injury.

You may not qualify if:

• The subject has a PNI with a segmental loss (gap) that cannot be repaired with minimal or acceptable tension.
• Other treatments known to affect the growth and/or physiology of the neural and vascular system.
• The nerve injury has vascular damage that cannot be repaired to provide adequate perfusion of the injured site.
• The subject is pregnant and/or is breastfeeding.
• The subject has a significant medical comorbidity precluding immediate repair.

Sponsors & Collaborators

• Neuraptive Therapeutics Inc.: lead

Study Sites (10)

UF Health - University of FL - Gainesville

Gainesville, Florida, 32607, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

Curtis National Hand Center

Baltimore, Maryland, 21218, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

The Ohio State University Wexner Medical Center Hand and Upper Extremity Center

Columbus, Ohio, 43202, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23398, United States

Location

Harborview Medical Center

Seattle, Washington, 98107, United States

Location

Related Publications (5)

• Ghergherehchi CL, Mikesh M, Sengelaub DR, Jackson DM, Smith T, Nguyen J, Shores JT, Bittner GD. Polyethylene glycol (PEG) and other bioactive solutions with neurorrhaphy for rapid and dramatic repair of peripheral nerve lesions by PEG-fusion. J Neurosci Methods. 2019 Feb 15;314:1-12. doi: 10.1016/j.jneumeth.2018.12.015. Epub 2018 Dec 23.

  PMID: 30586569 BACKGROUND

• Mikesh M, Ghergherehchi CL, Louis Hastings R, Ali A, Rahesh S, Jagannath K, Sengelaub DR, Trevino RC, Jackson DM, Bittner GD. Corrigendum to "Polyethylene glycol solutions rapidly restore and maintain axonal continuity, neuromuscular structures, and behaviors lost after sciatic nerve transections in female rats.". J Neurosci Res. 2018 Sep;96(9):1623. doi: 10.1002/jnr.24277. No abstract available.

  PMID: 30113719 BACKGROUND

• Mikesh M, Ghergherehchi CL, Rahesh S, Jagannath K, Ali A, Sengelaub DR, Trevino RC, Jackson DM, Tucker HO, Bittner GD. Corrigendum to "Polyethylene glycol treated allografts not tissue matched nor immunosuppressed rapidly repair sciatic nerve gaps, maintain neuromuscular functions, and restore voluntary behaviors in female rats". J Neurosci Res. 2018 Sep;96(9):1624. doi: 10.1002/jnr.24278. No abstract available.

  PMID: 30113723 BACKGROUND

• Bittner GD, Spaeth CS, Poon AD, Burgess ZS, McGill CH. Repair of traumatic plasmalemmal damage to neurons and other eukaryotic cells. Neural Regen Res. 2016 Jul;11(7):1033-42. doi: 10.4103/1673-5374.187019.

  PMID: 27630671 BACKGROUND

• Bittner GD, Sengelaub DR, Trevino RC, Peduzzi JD, Mikesh M, Ghergherehchi CL, Schallert T, Thayer WP. The curious ability of polyethylene glycol fusion technologies to restore lost behaviors after nerve severance. J Neurosci Res. 2016 Mar;94(3):207-30. doi: 10.1002/jnr.23685. Epub 2015 Nov 3.

  PMID: 26525605 BACKGROUND

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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 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 10, 2020
• First Posted: October 1, 2020
• Study Start: September 25, 2020
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)