Skip to main content
OpenTrials
Completed

NCT Number: NCT04572906

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UF Health - University of FL - Gainesville, Gainesville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: PEG-fusion

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

    Time frame: Up to 48 Weeks

    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.

  2. Michigan Hand Questionnaire Total Score (MHQ)

    Time frame: Week 12

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

Secondary outcomes

  1. Numeric Pain Rating Scale (NPRS)

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

    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.

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

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

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

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

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

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

  4. Semmes-Weinstein Monofilament Test (SWMT)

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

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

  5. Pinch Strength

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

    The Pinch test assesses strength using using equipment that measures strength in pounds.

  6. Grip Strength

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

    The Grip test assesses strength using using equipment that measures strength in pounds.

  7. Cold Intolerance Symptom Severity (CISS)

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

    The CISS focuses on the impact of cold intolerance on activities of daily life; the score ranges a score between 0 and 10, where 0 is no symptoms at all and 100 is the most severe symptoms you can possibly imagine.

  8. Patient Global Impression of Change (PGIC)

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

    The PGIC measures information about the effect of a treatment intervention in an individual subject, scored 0 to 7; with 0 being the worst and 7 being the best.

Sponsors and collaborators

Lead sponsor

Neuraptive Therapeutics Inc.

Industry

Registry information

Official study title

Phase 2a, Multicenter, Randomized, Patient and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to SOC in the Treatment of Acute Single Transected Peripheral Nerve Injury Occurring Below the Distal Border of the Brachial Plexus Requiring Surgical Repair.

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2020
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.