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

Neuraptive Therapeutics Inc.51 enrolled

Overview

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.

NTX-001 (Product) is a surgical product that consists of an active solution (drug), an isolation chamber medical device (chamber or device) and two (2) other sterile solutions. 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Peripheral Nerve Injuries

Interventions

NTX-001COMBINATION_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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (10)

UF Health - University of FL - Gainesville

Gainesville, Florida, United States

Orlando Health

Orlando, Florida, United States

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Week 12

Secondary Outcomes

Numeric Pain Rating Scale (NPRS)

The NPRS measures pain intensity on a scale from 0 representing no pain and 10 to the worst pain as bad as you can imagine.

Time frame: Weeks 4, 8, 12, 24, 36 and 48

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

The SWMT measures sensation as using a score from S0 to S4; higher score indicates better sensation.

Time frame: Weeks 4, 8, 12, 24, 36 and 48

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

The MRCC motor measures the function of the muscles; on a scale from M0 to M5; the higher score indicates better strength.

Time frame: Weeks 4, 8, 12, 24, 36 and 48

Semmes-Weinstein Monofilament Test (SWMT)

The SWMT assesses sensation using using equipment that measures force felt in grams.

Time frame: Weeks 4, 8, 12, 24, 36 and 48

Data from ClinicalTrials.gov

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