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Este estudo avaliará a eficácia do NTX-001, um produto cirúrgico de reparo nervoso, quando usado em pessoas com lacerações nervosas das extremidades superiores de nervos sensoriais ou motores mistos.

2 de outubro de 2026 atualizado por: Neuraptive Therapeutics Inc.

Um estudo de fase 3, multicêntrico, randomizado, sujeito e avaliador cego e controlado que avalia a segurança e a eficácia do NTX-001 em comparação com o tratamento padrão (neurorrafia) no tratamento de nervos seccionados da extremidade superior que requerem reparo cirúrgico.

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

98

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90048
        • Ainda não está recrutando
        • Cedars Sinai Medical Center
        • Contato:
        • Contato:
        • Investigador principal:
          • Meghan C McCullough, MD
      • San Francisco, California, Estados Unidos, 94158
        • Ainda não está recrutando
        • UCSF Health
        • Contato:
        • Contato:
    • Florida
      • Orlando, Florida, Estados Unidos, 32806
      • Orlando, Florida, Estados Unidos, 32804
        • Recrutamento
        • Rothman Orthopedics - Advent Health
        • Contato:
        • Contato:
        • Investigador principal:
          • Amir Reza Kachooei, MD PhD
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30303
        • Recrutamento
        • Grady Health
        • Contato:
        • Contato:
        • Investigador principal:
          • Nicole A Zelenski, MD
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • Recrutamento
        • University of Chicago
        • Contato:
        • Contato:
        • Investigador principal:
          • Jeffrey Stepan, MD
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40202
        • Recrutamento
        • University of Louisville
        • Contato:
        • Contato:
        • Investigador principal:
          • Tuna Ozyurekoglu, MD
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70112
        • Recrutamento
        • Louisiana State University Health Sciences Center
        • Investigador principal:
          • Harvey Chim, MD, FACS
        • Contato:
        • Contato:
          • Tanja Milosavljevic, MSc, PhD
          • Número de telefone: 504-568-6876
          • E-mail: tmilos@lsuhsc.edu
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21218
        • Recrutamento
        • Curtis National Center at MedStar Union Memorial Hospital
        • Contato:
        • Contato:
        • Investigador principal:
          • Kenneth R Means Jr., MD
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65211
      • St Louis, Missouri, Estados Unidos, 63110
        • Recrutamento
        • Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.
        • Contato:
          • David M Brogan, MD, MSc
          • Número de telefone: 314-747-2813
          • E-mail: brogand@wustl.edu
        • Investigador principal:
          • David M Brogan, MD, MSc
        • Contato:
    • New Jersey
      • Camden, New Jersey, Estados Unidos, 08103
        • Recrutamento
        • The Cooper Health System
        • Contato:
        • Contato:
        • Investigador principal:
          • David A Fuller, MD
    • New York
      • New York, New York, Estados Unidos, 10003
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45267
        • Recrutamento
        • UC Health
        • Investigador principal:
          • Sonu Jain, MD
        • Contato:
          • Sonu Jain, MD, FACS
          • Número de telefone: 513-558-2765
          • E-mail: sonu.jain@uc.edu
        • Contato:
          • Brittany Rowley, CCRC Clinical Research Professional III
          • Número de telefone: 513-558-2765
          • E-mail: rowleybm@ucmail.uc.edu
      • Cincinnati, Ohio, Estados Unidos, 45267
        • Recrutamento
        • University of Cincinnati Health
        • Investigador principal:
          • Sonu Jain, MD
        • Contato:
        • Contato:
      • Cleveland, Ohio, Estados Unidos, 44109
        • Recrutamento
        • The MetroHealth System
        • Contato:
        • Contato:
        • Investigador principal:
          • Kyle Chepla, MD
      • Columbus, Ohio, Estados Unidos, 43212
        • Recrutamento
        • The Ohio State University Wexner Medical Center
        • Contato:
        • Contato:
        • Investigador principal:
          • Ryan Schmucker, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Recrutamento
        • University of Pennsylvania, Department of Orthopaedic Surgery
        • Contato:
        • Contato:
        • Investigador principal:
          • Ines C Lin, MD
      • Pittsburgh, Pennsylvania, Estados Unidos, 15212
        • Recrutamento
        • Allegheny Health Network
        • Contato:
        • Contato:
          • Mary Fetter - Lead Clinical Research Coordinator
          • Número de telefone: 412-359-8292
          • E-mail: Mary.Fetter@ahn.org
        • Investigador principal:
          • Steven Regal, MD
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29429
        • Recrutamento
        • Medical University of South Carolina
        • Contato:
        • Contato:
          • Charles A Daly, MD
          • Número de telefone: 843-876-2211
          • E-mail: dalyc@musc.edu
        • Investigador principal:
          • Charles Daly, MD
    • Texas
      • Dallas, Texas, Estados Unidos, 75246
        • Recrutamento
        • Baylor, Scott and White Health
        • Contato:
        • Contato:
        • Investigador principal:
          • Asadullah Helal, MD
      • Lubbock, Texas, Estados Unidos, 79415
        • Recrutamento
        • Texas Tech
        • Investigador principal:
          • Brendan MacKay, MD
        • Contato:
        • Contato:
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84132
        • Recrutamento
        • University of Utah Health
        • Contato:
        • Contato:
        • Investigador principal:
          • Mark Mahan, MD, FAANS
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • Recrutamento
        • UVA Health
        • Contato:
        • Contato:
        • Investigador principal:
          • Brett DeGeorge, MD
    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • Recrutamento
        • Harborview Medical Center
        • Contato:
          • Laura Hennessy, RN
          • Número de telefone: 206-744-7723
          • E-mail: hennessy@uw.edu
        • Contato:
          • Yusha ( Katie) Liu, MD PhD
          • Número de telefone: 206-744-3000
          • E-mail: HMCnerve@uw.edu
        • Investigador principal:
          • Katie Liu, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: NTX-001

NTX-001 used during the surgical repair of an upper extremity peripheral nerve injury in conjunction with standard suture neurorrhaphy.
Produto combinado: 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.
Sem intervenção: Standard Suture Neurorrhaphy

Standard of Care

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain)
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Intraoperative CheckPoint® Stimulation.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Electromyography (EMG) Testing
Prazo: 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)
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Neuraptive Therapeutics Inc.

Investigadores

  • Diretor de estudo: Seth Schulman, MD, Neuraptive Therapeutics Inc.

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de fevereiro de 2025

Conclusão Primária (Estimado)

31 de março de 2027

Conclusão do estudo (Estimado)

30 de abril de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

24 de setembro de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de setembro de 2024

Primeira postagem (Real)

27 de setembro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de outubro de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NTx24301

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