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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04572906
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
Information provided by (Responsible Party):
Neuraptive Therapeutics Inc.

Brief Summary:
NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of a severed nerves in patients between 16 and 65 years of age.

Condition or disease Intervention/treatment Phase
Peripheral Nerve Injuries Combination Product: NTX-001 Phase 2

Detailed Description:

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

NTX-001 has been developed as 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Treatment vs. Standard of Care
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: All study personnel involved in the surgical procedure will be unblinded. Patient and outcomes evaluators will be blinded.
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : April 15, 2023
Estimated Study Completion Date : June 15, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NTX-001
NTX-001 used during surgical repair of an upper extremity peripheral nerve injury in conjuction with standard suture neurorrhaphy.
Combination Product: NTX-001
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 Name: PEG-fusion

No Intervention: Standard of Care
standard suture neurorrhaphy

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The subject is at least 16 years of age and not older than 65.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04572906

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Contact: Vicki J Abbas, BSN RN 303-263-4646
Contact: Seth Schulman, MD 617-416-4520

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United States, Maryland
Curtis National Hand Center Recruiting
Baltimore, Maryland, United States, 21218
Contact: Kenneth R Means Jr., MD    410-235-5405   
Contact: Ike C. Fleming, CCRC    410-554-2486   
Sponsors and Collaborators
Neuraptive Therapeutics Inc.
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Study Chair: Seth Schulman, MD Neuraptive Therapeutics Inc.

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Responsible Party: Neuraptive Therapeutics Inc. Identifier: NCT04572906    
Other Study ID Numbers: NTx20201
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nerve Injuries
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Trauma, Nervous System