Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Denne undersøgelse vil evaluere effektiviteten af ​​NTX-001, et kirurgisk nervereparationsprodukt, når det bruges til personer med nerveskader i øvre ekstremiteter af sensoriske eller blandede motoriske nerver.

2. oktober 2026 opdateret af: Neuraptive Therapeutics Inc.

En fase 3, multicenter, randomiseret, forsøgsperson og evaluator blindet, kontrolleret undersøgelse, der evaluerer sikkerheden og effektiviteten af ​​NTX-001 sammenlignet med standardbehandling (neurorrafi) ved behandling af øvre ekstremitetstransected nerver, der kræver kirurgisk reparation.

NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

98

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90048
        • Ikke rekrutterer endnu
        • Cedars Sinai Medical Center
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Meghan C McCullough, MD
      • San Francisco, California, Forenede Stater, 94158
        • Ikke rekrutterer endnu
        • UCSF Health
        • Kontakt:
        • Kontakt:
    • Florida
      • Orlando, Florida, Forenede Stater, 32806
      • Orlando, Florida, Forenede Stater, 32804
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30303
        • Rekruttering
        • Grady Health
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Nicole A Zelenski, MD
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • Rekruttering
        • University of Chicago
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Jeffrey Stepan, MD
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Rekruttering
        • University of Louisville
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Tuna Ozyurekoglu, MD
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Rekruttering
        • Louisiana State University Health Sciences Center
        • Ledende efterforsker:
          • Harvey Chim, MD, FACS
        • Kontakt:
        • Kontakt:
          • Tanja Milosavljevic, MSc, PhD
          • Telefonnummer: 504-568-6876
          • E-mail: tmilos@lsuhsc.edu
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21218
        • Rekruttering
        • Curtis National Center at MedStar Union Memorial Hospital
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Kenneth R Means Jr., MD
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65211
      • St Louis, Missouri, Forenede Stater, 63110
        • Rekruttering
        • Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.
        • Kontakt:
        • Ledende efterforsker:
          • David M Brogan, MD, MSc
        • Kontakt:
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
    • New York
      • New York, New York, Forenede Stater, 10003
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • Rekruttering
        • UC Health
        • Ledende efterforsker:
          • Sonu Jain, MD
        • Kontakt:
        • Kontakt:
          • Brittany Rowley, CCRC Clinical Research Professional III
          • Telefonnummer: 513-558-2765
          • E-mail: rowleybm@ucmail.uc.edu
      • Cincinnati, Ohio, Forenede Stater, 45267
        • Rekruttering
        • University of Cincinnati Health
        • Ledende efterforsker:
          • Sonu Jain, MD
        • Kontakt:
        • Kontakt:
      • Cleveland, Ohio, Forenede Stater, 44109
        • Rekruttering
        • The MetroHealth System
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Kyle Chepla, MD
      • Columbus, Ohio, Forenede Stater, 43212
        • Rekruttering
        • The Ohio State University Wexner Medical Center
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Ryan Schmucker, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Rekruttering
        • University of Pennsylvania, Department of Orthopaedic Surgery
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Ines C Lin, MD
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Rekruttering
        • Allegheny Health Network
        • Kontakt:
        • Kontakt:
          • Mary Fetter - Lead Clinical Research Coordinator
          • Telefonnummer: 412-359-8292
          • E-mail: Mary.Fetter@ahn.org
        • Ledende efterforsker:
          • Steven Regal, MD
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29429
        • Rekruttering
        • Medical University of South Carolina
        • Kontakt:
        • Kontakt:
          • Charles A Daly, MD
          • Telefonnummer: 843-876-2211
          • E-mail: dalyc@musc.edu
        • Ledende efterforsker:
          • Charles Daly, MD
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • Rekruttering
        • Baylor, Scott and White Health
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Asadullah Helal, MD
      • Lubbock, Texas, Forenede Stater, 79415
        • Rekruttering
        • Texas Tech
        • Ledende efterforsker:
          • Brendan MacKay, MD
        • Kontakt:
        • Kontakt:
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Rekruttering
        • University of Utah Health
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Mark Mahan, MD, FAANS
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22903
        • Rekruttering
        • UVA Health
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Brett DeGeorge, MD
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Rekruttering
        • Harborview Medical Center
        • Kontakt:
        • Kontakt:
          • Yusha ( Katie) Liu, MD PhD
          • Telefonnummer: 206-744-3000
          • E-mail: HMCnerve@uw.edu
        • Ledende efterforsker:
          • Katie Liu, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form.
  • The subject is between eighteen (18) and eighty (80) years of age.
  • The subject has clinical evidence of a Sunderland's 4th degree (Class II) or 5th degree (Class III) nerve transection(s) that has resulted in upper extremity nerve impairment that requires surgical treatment.

Exclusion Criteria:

  • Subjects whose nerve repair will occur greater than 48 hours after nerve transection.
  • Subjects requiring nerve repair involving an autograft, allograft or conduit(s).
  • Subjects with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair.
  • Subjects who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow up due to significant muscle atrophy or other morbidity.
  • The subject's injury is a result of a suicide attempt or self- harm.
  • The subject has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system).
  • The subject has a known allergy to polyethylene glycol (PEG) or human grade silicone.
  • The subject is pregnant or breastfeeding.
  • The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: NTX-001

NTX-001 used during the surgical repair of an upper extremity peripheral nerve injury in conjunction with standard suture neurorrhaphy.
Kombinationsprodukt: NTX-001 (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.
Ingen indgriben: Standard Suture Neurorrhaphy

Standard of Care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain)
Tidsramme: Screening Visit, Week 24

The subject will complete the MHQ questionnaire at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48. A measure of the mean of MHQ in the Two Domains, Activities of Daily Living and Pain Scores, at Week 24 in the NTX-001 group as compared to Standard of Care (SoC). In the ADL subdomain, a higher component score indicates better function. In the Pain subdomain, a higher component score indicates greater pain. A total MHQ score of 100 is considered the best functional score.
Screening Visit, Week 24
Safety - Columbia-Suicide Severity Rating Scale
Tidsramme: Screening Visit, Weeks 4, 12, and 48

The Columbia-Suicide Severity Rating Scale (C-SSRS) is a suicide risk assessment tool. The C-SSRS tool asks; whether and when the subject has had a thought about suicide (ideation); what actions they might have taken and what they did to prepare for suicide; whether and when they attempted suicide or began a suicide attempt that was either interrupted by another person or stopped of their own volition. The answers identify whether someone is at risk for suicide, assessing the severity and immediacy of that risk, and gauging the level of support that the person needs. The first assessment is done by study staff at screening. Subsequent assessments will be completed by the subject at Weeks 4, 12, and 48. A score of 0 indicates no risk, 1-2 indicates low risk, and 3+ indicates moderate to high risk.
Screening Visit, Weeks 4, 12, and 48

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intraoperative CheckPoint® Stimulation.
Tidsramme: In Operating Room

A CheckPoint® Stimulator will be used intra-operatively to detect immediate reconnection of severed peripheral nerves (axons) in mixed-motor nerves only. The measures include in response of direct nerve stimulation, proximally and distally to suture site.
In Operating Room
MHQ Total Score
Tidsramme: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48

The MHQ quantifies different impairments between the subjects in uninjured and involved upper extremities. A general survey of hand function includes twenty-five items for the right and the left hand, as well as questions for both hands. Questions regarding function specifically refer to the impact of the involved hand and/or wrist on the activity which presumably takes all joints of the upper extremity into account. The overall questionnaire is scored from 0 to 100, with 100 being the optimal score.
Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48
Time to Return to Function
Tidsramme: Screening Visit, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.

Achievement of seventy-five (75)% function in the combined ADL and pain MHQ domain scores. The Activities of Daily Living component evaluates the ability to perform specific tasks using either hand or both hands together. The Pain subdomain addresses the frequency and intensity of pain in both the right and left hands/wrists, along with its impact on sleep and daily activities, and the emotional distress it causes. The overall questionnaire is scored from 0 to 100, with 100 being the optimal score.
Screening Visit, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.
Change in NPRS
Tidsramme: Screening Visit, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 30, 36, 42, and 48

The NPRS is used to assess for pain and to determine pain intensity. The NPRS is an 11-point scale scored from 0-10: 1) "0" = no pain 2) "10" = the most intense pain imaginable. The average of the 3 ratings is used to represent the subject's level of pain over the previous 24 hours.
Screening Visit, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 30, 36, 42, and 48
Semmes Weinstein Monofilament Test (SWMT)
Tidsramme: Weeks 2, 4, 8, 12, 24, 36, 48.

SWMT provides information on protective sensation, the rigorous system can detect relatively minor differences in sensory function, and changes will occur early in nerve injury. The assessment tool consists of a set of monofilaments that vary in thickness and diameter, the gradient forces of these monofilaments that subjects' can feel, range from 0.086 gm to 0.448gm. The normal value in the hand is in the range of the green filament (1.65 to 2.83 mN).
Weeks 2, 4, 8, 12, 24, 36, 48.
MHQ Two Domain Score
Tidsramme: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, 48

The Activities of Daily Living component evaluates the ability to perform specific tasks using either hand or both hands together. The Pain subdomain addresses the frequency and intensity of pain in both the right and left hands/wrists, along with its impact on sleep and daily activities, and the emotional distress it causes. The raw scale score for each of the 6 scales is the sum of the responses of each scale item. The raw score is converted to a score range from 0 to 100. 100 being the best.
Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, 48
Change from Week 2 in MHQ Two Domain Score
Tidsramme: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.

The Activities of Daily Living component evaluates the ability to perform specific tasks using either hand or both hands together. The Pain subdomain addresses the frequency and intensity of pain in both the right and left hands/wrists, along with its impact on sleep and daily activities, and the emotional distress it causes. The raw scale score for each of the 6 scales is the sum of the responses of each scale item. The raw score is converted to a score range from 0 to 100. 100 being the best.
Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.
Medical Research Council Classification (MRCC) Sensory Score
Tidsramme: Weeks 2, 4, 8, 12, 24, 36, and 48.

The scale is commonly used including 2 Point Discrimination for grading the sensory outcome after peripheral nerve surgery. This scale is categorized into S0-S4: S0 is the absence of sensibility; S1 is the recovery of deep cutaneous pain; S2 is the return of superficial cutaneous pain and some degree of tactile sensibility; S3 is the return of superficial cutaneous pain and tactile sensibility without over response; and S4 is the complete recovery.
Weeks 2, 4, 8, 12, 24, 36, and 48.
Medical Research Council Classification (MRCC) Motor Score
Tidsramme: Weeks 2, 4, 8, 12, 24, 36, 48

This assessment is conducted on mixed motor nerve injuries only. Strength can best be assessed by isolating an individual muscle group and comparing power with that of the subject. It can be conducted to assess larger muscles or muscle groups as well as intrinsic muscles of the hand. Measuring the difference between the affected limb and the contralateral limb. 0/5 is no muscle activation whatsoever; 1/5 is muscle activation without limb movement; 2/5 implies that the limb can be moved only when gravity is taken out of the equation; 3/5 means that the subject can overcome gravity but not resistance;• 4/5 (or 4+ or 4-) implies weakness with enough strength to overcome varying degrees of physical resistance; 5/5 is full strength.
Weeks 2, 4, 8, 12, 24, 36, 48
Change from Baseline (W2) in Numeric Pain Rating Scale (NPRS)
Tidsramme: Weeks 2, 24.

The NPRS is used to assess for pain and to determine pain intensity. The NPRS is an 11-point scale scored from 0-10: 1) "0" = no pain 2) "10" = the most intense pain imaginable. The average of the 3 ratings is used to represent the subject's level of pain over the previous 24 hours.
Weeks 2, 24.
Patient Global Impression of Change Score
Tidsramme: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, and 48

This scale evaluates all aspects of patients; health and assesses if there has been an improvement or decline in clinical status. PGIC is a 7-point scale depicting a subjects rating of overall improvement. The subject rates their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, and 48
Change in Total MHQ Score
Tidsramme: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.

The MHQ quantifies different impairments between the subjects uninjured and involved upper extremities. It was designed as a general survey of hand function and includes twenty-five items for the right and the left hand, as well as questions for both hands. Furthermore, questions regarding function specifically refer to the impact of the involved hand and/or wrist on the activity which presumably takes all joints of the upper extremity into account. The overall questionnaire is scored from 0 to 100, with 100 being the optimal score.
Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.
Change from Baseline in Patient Global Impression of Severity Score (PGIS)
Tidsramme: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42 and 48.

The PGIS is a single question asking the subject to rate the severity of the injury from the last visit. PGIS is a scale depicting a subject's rating of overall severity. The subject scores their perception of severity as "none," "mild," "moderate," "severe," or "very severe."
Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42 and 48.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Electromyography (EMG) Testing
Tidsramme: Weeks 12, 24.

EMG will be used to detect reconnection of severed peripheral nerves (axons) using PEG Fusion. Restoration of nerve conduction indicates the restoration of axon continuity, which is a prerequisite for the prevention of Wallerian degeneration, neuromuscular junction degeneration, muscle atrophy and functional recovery. This testing will be done at select clinical sites.
Weeks 12, 24.
Nerve Conduction Velocity (NCV)
Tidsramme: Weeks 12, 24

NVC testing measures how fast an electrical impulse moves through a nerve. This testing will be done at select clinical sites.
Weeks 12, 24
Physical and Occupational Therapy
Tidsramme: Weeks 2, 4, 8, 12, 24, 36, and 48.

Each subject will have the number of times physical therapy and/or occupational therapy is prescribed to determine if this activity affects the sensory and functional outcomes of the nerve repair between NTX-001 and SOC.
Weeks 2, 4, 8, 12, 24, 36, and 48.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Neuraptive Therapeutics Inc.

Efterforskere

  • Studieleder: Seth Schulman, MD, Neuraptive Therapeutics Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. februar 2025

Primær færdiggørelse (Anslået)

31. marts 2027

Studieafslutning (Anslået)

30. april 2027

Datoer for studieregistrering

Først indsendt

24. september 2024

Først indsendt, der opfyldte QC-kriterier

24. september 2024

Først opslået (Faktiske)

27. september 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. oktober 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NTx24301

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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