Peripheral Nerve InjuriesPhase 2NCT04572906
Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries
A Phase 2 study testing NTX-001 in people with Peripheral Nerve Injuries, run by Neuraptive Therapeutics Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- NTX-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 10 sitesUnited States
- Study dates
- 25 Sep 2020to 27 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Curtis National Hand Center
Baltimore, Maryland, 21218
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
University of Chicago
Chicago, Illinois, 60637
The Ohio State University Wexner Medical Center Hand and Upper Extremity Center
Columbus, Ohio, 43202
UF Health - University of FL - Gainesville
Gainesville, Florida, 32607
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
Orlando Health
Orlando, Florida, 32806
Virginia Commonwealth University
Richmond, Virginia, 23398
Harborview Medical Center
Seattle, Washington, 98107
Washington University
St Louis, Missouri, 63110
About this study
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.
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.
Read the detailed description
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.
- Conditions
- Peripheral Nerve Injuries
- Being tested
- NTX-001
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTX-001Combination product
Also called PEG-fusion
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.
| Study group | Role | What they receive |
|---|---|---|
| NTX-001 | Experimental | NTX-001 used during surgical repair of an upper extremity peripheral nerve injury in conjuction with standard suture neurorrhaphy. Receives: Combination Product: NTX-001 |
| Standard of Care | No intervention | standard suture neurorrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Michigan Hand Questionnaire Total Score (MHQ)
The MHQ measures hand function and is scored from 0-100; with 100 being the "best" score.
Measured: Baseline and Week 12
Secondary outcomes (7)
Responder Analysis for % Recovery of MHQ Total Score > Than or = to 75% Cutoff
The MHQ measures hand function and is scored from 0-100; with 100 being the "best" score.
Measured: Baseline, Weeks 8, 12, 24, 48
Change From Baseline 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.
Measured: Baseline and at Weeks 4, 8, 12, 24, 36 and 48
Number of Responders to Modified British Medical Research Council (MMRC) Sensory Grading (S0-S4)
The MMRC sensory grading scale was used to assess sensory recovery based on pain/touch sensibility and static and moving two-point discrimination testing (STPD and MTPD). The scale ranges from S0 to S4, where S0 = no sensory recovery; S1 = recovery of deep cutaneous pain sensibility; S2 = recovery of some superficial pain and tactile sensibility; S3 = recovery of pain and tactile sensibility with imperfect localization and two-point discrimination; and S4 = complete sensory recovery. Higher scores indicate better sensory recovery. A responder was defined as a participant achieving a sensory recovery grade of S3 or greater (S3+). Data presented are the percentage of participants who met the S3+ responder criterion at each assessment time point.
Measured: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Number of Responders to Modified British Medical Research Council (MMRC) Motor Grading (M0-M5)
The MMRC motor grading scale was used to assess motor recovery. Motor function was evaluated on an ordinal scale ranging from M0 to M5, where M0 indicates no muscle contraction and M5 indicates normal muscle strength. Grades were defined as follows: M0 = no contraction; M1 = muscle contraction without joint movement; M2 = active movement with gravity eliminated; M3 = active movement against gravity; M4 = active movement against resistance; and M5 = normal muscle strength. Higher scores indicate better motor recovery. A responder was defined as a participant achieving a motor function score of M3 or greater (M3+). Data presented are the percentage of participants meeting the M3+ responder criterion at each assessment time point.
Measured: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Number of Responders to Semmes-Weinstein Monofilament Test (SWMT)
The Semmes-Weinstein Monofilament Test (SWMT) was used to assess sensory function of the affected nerve. A responder was defined as a participant with a return to normal gauge sensation (2.83 g) for the affected nerve. Lower scores indicate better sensory function, with 2.83 g corresponding to normal sensation. Data presented are the percentage of participants who met the responder criterion at each assessment time point.
Measured: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change From Baseline Cold Intolerance Symptom Severity (CISS)
The CISS focuses on the impact of cold intolerance on activities of daily life; the score ranges a score between 0 and 100, where 0 is no symptoms at all and 100 is the most severe symptoms you can possibly imagine.
Measured: Baseline and at Weeks 4, 8, 12, 24 and 48
Number of Responders to Patient Global Impression of Change (PGIC)
The Patient Global Impression of Change (PGIC) is a patient-reported assessment of overall change in health status since treatment initiation. Participants rate their condition on a 7-point scale: 1 = very much worse, 2 = much worse, 3 = minimally worse, 4 = no change, 5 = minimally improved, 6 = much improved, and 7 = very much improved. Higher scores indicate greater perceived improvement. A responder was defined as a participant with a PGIC score of 5 or greater. Data presented are the percentage of participants who met the responder criterion at each assessment time point.
Measured: Baseline, Weeks 4, 8, 12, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start25 Sep 2020
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nerve InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment vs. Standard of Care
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuraptive Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seth Schulman, MD, Study chair, Neuraptive Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572906
- Sponsor's protocol ID
- NTx20201
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2020
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30586569Mikesh 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.
PubMed 30113719Mikesh 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.
PubMed 30113723Bittner 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.
PubMed 27630671Bittner 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.
PubMed 26525605
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04572906
- Acronym / sponsor ID
- NTx20201
- Conditions
- Peripheral Nerve Injuries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Neuraptive Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Posted 15 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment vs. Standard of Care
| Arm | Type | Receives |
|---|---|---|
| NTX-001 | Experimental | Combination Product: NTX-001NTX-001 used during surgical repair of an upper extremity peripheral nerve injury in conjuction with standard suture neurorrhaphy. |
| Standard of Care | No intervention | –standard suture neurorrhaphy |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTX-001Also: PEG-fusionOne 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. | Combination product | NTX-001 |
Primary outcome
Change From Baseline Michigan Hand Questionnaire Total Score (MHQ)
Time frame: Baseline and Week 12
The MHQ measures hand function and is scored from 0-100; with 100 being the "best" score.
7 secondary outcomes
Responder Analysis for % Recovery of MHQ Total Score > Than or = to 75% Cutoff
Time frame: Baseline, Weeks 8, 12, 24, 48
Change From Baseline Numeric Pain Rating Scale (NPRS)
Time frame: Baseline and at Weeks 4, 8, 12, 24, 36 and 48
Number of Responders to Modified British Medical Research Council (MMRC) Sensory Grading (S0-S4)
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Number of Responders to Modified British Medical Research Council (MMRC) Motor Grading (M0-M5)
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Number of Responders to Semmes-Weinstein Monofilament Test (SWMT)
Time frame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change From Baseline Cold Intolerance Symptom Severity (CISS)
Time frame: Baseline and at Weeks 4, 8, 12, 24 and 48
Number of Responders to Patient Global Impression of Change (PGIC)
Time frame: Baseline, Weeks 4, 8, 12, 24 and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30586569Ghergherehchi 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.
- Background: PubMed 30113719Mikesh 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.
- Background: PubMed 30113723Mikesh 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.
- Background: PubMed 27630671Bittner 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.
- Background: PubMed 26525605Bittner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Schulman, MD study chair
Neuraptive Therapeutics Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NTX-001 in people with Peripheral Nerve Injuries, run by Neuraptive Therapeutics Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Michigan Hand Questionnaire Total Score (MHQ) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04572906, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.