Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries
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|ClinicalTrials.gov Identifier: NCT04572906|
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Nerve Injuries||Combination Product: NTX-001||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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.|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04572906
|Contact: Vicki J Abbas, BSN RNemail@example.com|
|Contact: Seth Schulman, MDfirstname.lastname@example.org|
|Study Chair:||Seth Schulman, MD||Neuraptive Therapeutics Inc.|