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Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy (MCPAIN)

25 de agosto de 2026 actualizado por: Brian Callaghan, University of Michigan

Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy (MCPAIN)

The research team will perform a comparative-effectiveness sequential, multiple assignment, randomized trial in painful diabetic neuropathy (PDN) patients for 8 total months, divided into two 4-month stages. 600 participants 18+ with PDN will be enrolled in this study. The main goal is to compare the utility of three modalities (oral, topical, and behavioral) for initial PDN treatment, and to compare the utility of switching modalities versus continuing with the same modality for non-responders. Pain and discontinuation will be assessed weekly, whereas other outcomes will be assessed monthly for 8 months.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

600

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Fallon Koenig, MS, CCRP
  • Número de teléfono: 734-936-8778
  • Correo electrónico: fakoenig@med.umich.edu

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Stanford, California, Estados Unidos, 94305
        • Stanford University
        • Contacto:
        • Investigador principal:
          • Dong In Sinn
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32209
        • University of Florida-Jacksonville
        • Contacto:
        • Investigador principal:
          • Joe Chehade
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • Rush University Medical Center
        • Contacto:
        • Investigador principal:
          • Rabia Malik
    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242
        • University of Iowa
        • Investigador principal:
          • Marcelo Correia
        • Contacto:
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70118
        • Tulane University
        • Investigador principal:
          • Vivian Fonseca
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21224
        • Johns Hopskins University
        • Investigador principal:
          • Eva Tseng
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48104
        • University of Michigan
        • Investigador principal:
          • Lynn Ang, MD
        • Contacto:
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • University of Minnesota
        • Contacto:
        • Investigador principal:
          • Pitcha Choompongpod
      • Minneapolis, Minnesota, Estados Unidos, 55407
        • Allina Health-Neurosciences Research
        • Contacto:
        • Investigador principal:
          • Goel Vasudha
      • Rochester, Minnesota, Estados Unidos, 55902
        • Mayo Clinic Rochester
        • Investigador principal:
          • Kamal Shouman
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65201
        • University of Missouri
        • Contacto:
        • Investigador principal:
          • Benjamin Crenshaw
    • Nebraska
    • New York
      • New York, New York, Estados Unidos, 10027
        • Columbia University
      • New York, New York, Estados Unidos, 10065
        • Will Cornell Medicine
        • Contacto:
        • Investigador principal:
          • Lisa Witkin
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
      • Durham, North Carolina, Estados Unidos, 27708
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health & Science University
        • Investigador principal:
          • Rodica Busui
        • Contacto:
    • Pennsylvania
      • Titusville, Pennsylvania, Estados Unidos, 16354
        • University of Pittsburgh
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Holly Thomas
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37208
        • Meharry Medical College
        • Contacto:
      • Nashville, Tennessee, Estados Unidos, 37235
        • University of Vanderbilt
    • Texas
      • Edinburg, Texas, Estados Unidos, 78539
        • DHR Health Institute for Research and Development
        • Contacto:
        • Investigador principal:
          • Marcel Twahirwa
      • McKinney, Texas, Estados Unidos, 75071
        • BaylorScott & White University Medical Center
        • Contacto:
        • Investigador principal:
          • Dana Bleakney
    • Wisconsin
      • Spooner, Wisconsin, Estados Unidos, 54801

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Diabetes
  • Painful Diabetic Neuropathy (confirmed at screening visit)
  • Willing to accept random treatment assignment to any of the proposed interventions

Exclusion Criteria:

  • Pregnancy or plans to become pregnant during the study
  • History of neuropathy from causes other than diabetes as determined through medical and family history, physical and neurologic examinations
  • HbA1c >10%
  • Participation in an experimental medication trial within 3 months of starting the study
  • Undergoing therapy for malignant disease other than basal-cell or squamous-cell skin cancer
  • Medical or psychiatric reason for not being a study candidate according to the site PI's discretion
  • Contraindications preventing trialing two interventions within any of the 3 modalities
  • Cirrhosis of the liver

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Oral Medication then New Oral Medication
Participants randomized to oral medications, and are considered non-responders at 4 months will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to oral medications will select a new oral medication for the next 4 months.
Droga: Oral Medication

Participants will work with their physician to select an oral medication from a list commonly used to treat PDN. Patients will follow standard of care dosing and tapering of the assigned drug.

Serotonin-Norepinephrine Reuptake Inhibitors (SNRI's): Duloxetine, Venlafaxine, Desvenlafaxine Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline Gabapentinoids: Gabapentin, Pregabalin Sodium Channel Blockers: Oxcarbazepine, Lamotrigine, Lacosamide
Experimental: Oral Medication then Same Oral Medication
Participants randomized to oral medications, and are considered responders at 4 months will continue with the same oral medication for the next 4 months.
Droga: Oral Medication

Participants will work with their physician to select an oral medication from a list commonly used to treat PDN. Patients will follow standard of care dosing and tapering of the assigned drug.

Serotonin-Norepinephrine Reuptake Inhibitors (SNRI's): Duloxetine, Venlafaxine, Desvenlafaxine Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline Gabapentinoids: Gabapentin, Pregabalin Sodium Channel Blockers: Oxcarbazepine, Lamotrigine, Lacosamide
Experimental: Oral Medication then Topical Medication
Participants randomized to oral medications, and are considered non-responders at 4 months will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to topical medications will select a topical medication for the next 4 months.
Droga: Oral Medication

Participants will work with their physician to select an oral medication from a list commonly used to treat PDN. Patients will follow standard of care dosing and tapering of the assigned drug.

Serotonin-Norepinephrine Reuptake Inhibitors (SNRI's): Duloxetine, Venlafaxine, Desvenlafaxine Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline Gabapentinoids: Gabapentin, Pregabalin Sodium Channel Blockers: Oxcarbazepine, Lamotrigine, Lacosamide

Droga: Topical Medication

Participants will work with their physician to select a topical medication from a list commonly used to treat PDN.

0.075% capsaicin cream (4 times daily) 4-5% lidocaine patches (1-4 patches every 24 hours)
Experimental: Oral Medication then Cognitive Behavioral Therapy
Participants randomized to oral medications, and are considered non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to a behavioral intervention will begin self-guided CBT for the next 4 months.
Droga: Oral Medication

Participants will work with their physician to select an oral medication from a list commonly used to treat PDN. Patients will follow standard of care dosing and tapering of the assigned drug.

Serotonin-Norepinephrine Reuptake Inhibitors (SNRI's): Duloxetine, Venlafaxine, Desvenlafaxine Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline Gabapentinoids: Gabapentin, Pregabalin Sodium Channel Blockers: Oxcarbazepine, Lamotrigine, Lacosamide

Dispositivo: Cognitive Behavioral Therapy (CBT)
Participants will work with study team to begin web-based, self-guided CBT (non-significant risk device) or traditional (one on one) CBT with a therapist (behavioral, not a device).
Experimental: Topical Medication then New Topical Medication
Participants randomized to topical medications, and are considered non-responders at 4 months will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to topical medications will select a new topical medication for the next 4 months.
Droga: Topical Medication

Participants will work with their physician to select a topical medication from a list commonly used to treat PDN.

0.075% capsaicin cream (4 times daily) 4-5% lidocaine patches (1-4 patches every 24 hours)
Experimental: Topical Medication then Same Topical Medication
Participants randomized to topical medications, and are considered responders at 4 months will continue with the same topical medication for the next 4 months.
Droga: Topical Medication

Participants will work with their physician to select a topical medication from a list commonly used to treat PDN.

0.075% capsaicin cream (4 times daily) 4-5% lidocaine patches (1-4 patches every 24 hours)
Experimental: Topical Medication then Oral Medication
Participants randomized to topical medications, and are considered non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to oral medications will select an oral medication for the next 4 months.
Droga: Oral Medication

Participants will work with their physician to select an oral medication from a list commonly used to treat PDN. Patients will follow standard of care dosing and tapering of the assigned drug.

Serotonin-Norepinephrine Reuptake Inhibitors (SNRI's): Duloxetine, Venlafaxine, Desvenlafaxine Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline Gabapentinoids: Gabapentin, Pregabalin Sodium Channel Blockers: Oxcarbazepine, Lamotrigine, Lacosamide

Droga: Topical Medication

Participants will work with their physician to select a topical medication from a list commonly used to treat PDN.

0.075% capsaicin cream (4 times daily) 4-5% lidocaine patches (1-4 patches every 24 hours)
Experimental: Topical Medication then Cognitive Behavioral Therapy
Participants randomized to topical medications, and are considered non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to a behavioral intervention will begin self-guided CBT for the next 4 months.
Droga: Topical Medication

Participants will work with their physician to select a topical medication from a list commonly used to treat PDN.

0.075% capsaicin cream (4 times daily) 4-5% lidocaine patches (1-4 patches every 24 hours)

Dispositivo: Cognitive Behavioral Therapy (CBT)
Participants will work with study team to begin web-based, self-guided CBT (non-significant risk device) or traditional (one on one) CBT with a therapist (behavioral, not a device).
Experimental: Cognitive Behavioral Therapy then Same Cognitive Behavioral Therapy
Participants randomized to behavioral interventions will all begin with self-guided CBT. If considered responders at 4 months they will continue with self-guided CBT for the next 4 months.
Dispositivo: Cognitive Behavioral Therapy (CBT)
Participants will work with study team to begin web-based, self-guided CBT (non-significant risk device) or traditional (one on one) CBT with a therapist (behavioral, not a device).
Experimental: Cognitive Behavioral Therapy then New Cognitive Behavioral Therapy
Participants randomized to behavioral interventions will all begin with self-guided CBT. If considered non-responders at 4 months, they will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to a behavioral intervention will begin traditional CBT for the next 4 months.
Dispositivo: Cognitive Behavioral Therapy (CBT)
Participants will work with study team to begin web-based, self-guided CBT (non-significant risk device) or traditional (one on one) CBT with a therapist (behavioral, not a device).
Experimental: Cognitive Behavioral Therapy then Oral Medication
Participants randomized to behavioral interventions will all begin with self-guided CBT. Non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to oral medications will select an oral medication for the next 4 months.
Droga: Oral Medication

Participants will work with their physician to select an oral medication from a list commonly used to treat PDN. Patients will follow standard of care dosing and tapering of the assigned drug.

Serotonin-Norepinephrine Reuptake Inhibitors (SNRI's): Duloxetine, Venlafaxine, Desvenlafaxine Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline Gabapentinoids: Gabapentin, Pregabalin Sodium Channel Blockers: Oxcarbazepine, Lamotrigine, Lacosamide

Dispositivo: Cognitive Behavioral Therapy (CBT)
Participants will work with study team to begin web-based, self-guided CBT (non-significant risk device) or traditional (one on one) CBT with a therapist (behavioral, not a device).
Experimental: Cognitive Behavioral Therapy then Topical Medication
Participants randomized to behavioral interventions will all begin with self-guided CBT. Non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to topical medications will select a topical medication for the next 4 months.
Droga: Topical Medication

Participants will work with their physician to select a topical medication from a list commonly used to treat PDN.

0.075% capsaicin cream (4 times daily) 4-5% lidocaine patches (1-4 patches every 24 hours)

Dispositivo: Cognitive Behavioral Therapy (CBT)
Participants will work with study team to begin web-based, self-guided CBT (non-significant risk device) or traditional (one on one) CBT with a therapist (behavioral, not a device).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient-centered utility function as a measure for efficacy and tolerability
Periodo de tiempo: Up to 8 months.
Efficacy and tolerability will be assessed and measured as utility function. Utility function ranges from 0-1.75, 0 being the lowest utility function and 1.75 being the highest utility function. Utility function that is a composite of efficacy (0-1) and discontinuation (0-1).
Up to 8 months.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain intensity
Periodo de tiempo: Up to 8 months.
Pain intensity as measured by first question of the "Pain, Enjoyment, General Activity" (PEG) numeric rating scale, where a score of 0 is no pain and 10 is the worst pain imaginable.
Up to 8 months.
Pain interference
Periodo de tiempo: Up to 8 months.
Pain interference as measured by the sum of the second two questions of the "Pain, Enjoyment, General Activity" (PEG) numeric rating scale, where a score of 0 is no interference with daily life and 20 is the complete interference with daily life.
Up to 8 months.
Discontinuation
Periodo de tiempo: Up to 8 months
Rate of treatment discontinuation for any reason, including withdrawal From enrollment to end of treatment at 8 months.
Up to 8 months
Related adverse events
Periodo de tiempo: Up to 8 months.
Adverse events reported by local sites and determined to be related to the treatment.
Up to 8 months.
Physical functioning/Quality of Life (QOL)
Periodo de tiempo: Up to 8 months.
Physical function/QOL as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical functioning Short Form 6b, a 5 question questionnaire. Each question is measured with a likert scale, where 5 is "without any difficulty" and 1 is "unable to do"
Up to 8 months.
Neuropathy specific QOL
Periodo de tiempo: Up to 8 months
Neuropathy Quality of Life (NeuroQOL) evaluates symptoms and function in regard to quality of life over the past four weeks. Range 1-15, higher score indicates neuropathy having a greater impact on quality of life.
Up to 8 months
Depression
Periodo de tiempo: Up to 8 months
As measured by the Patient Health Questionnaire (PHQ-2), a two-question questionnaire where each depression symptom is scored on a scale of 0-3, where 0 is "not at all" and 3 is "nearly every day". The total score range is 0-6 where the higher score indicates more depression symptoms.
Up to 8 months
Anxiety
Periodo de tiempo: Up to 8 months
As measured by the General Anxiety Disorder (GAD-2), a two-question questionnaire where each anxiety symptom is scored on a scale of 0-3, where 0 is "not at all" and 3 is "nearly every day". The total score range is 0-6 where the higher score indicates more anxiety symptoms.
Up to 8 months
Sleep
Periodo de tiempo: Up to 8 months
Sleep Quality represented by the sum of scores on the PROMIS Sleep Disturbance 6a and an additional question regarding sleep duration.
Up to 8 months
Pain Catastrophizing
Periodo de tiempo: Up to 8 months
As measured by the Pain Catastrophizing Scale Short Form 6, where a score of 0 is catastrophizing "not at all" and 52 is catastrophizing "all the time"
Up to 8 months
Global treatment satisfaction
Periodo de tiempo: Up to 8 months
As measured by Patient Global Impression of Change (PGIC), a single question on a scale of 0-6, where 0 is "very much improved" and 6 is "very much worse".
Up to 8 months
Substance use screener
Periodo de tiempo: Up to 8 months
As measured by the Tobacco, Alcohol, Prescription Medications, and other Substance (TAPS 1) questionnaire, which is five questions on a scale of 0-4, where 0 is "daily or almost daily use" and 4 is "never use".
Up to 8 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Michigan

Colaboradores

Patient-Centered Outcomes Research Institute

Investigadores

  • Investigador principal: Brian Callaghan, MD, University of Michigan

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de agosto de 2030

Finalización del estudio (Estimado)

1 de agosto de 2031

Fechas de registro del estudio

Enviado por primera vez

25 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

25 de agosto de 2026

Publicado por primera vez (Actual)

31 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HUM00292431
  • BPS-2025C2-45514 (Otro número de subvención/financiamiento: Patient-Centered Outcomes Research Institute (PCORI))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Full, de-identified datasets will be deposited in a PCORI-designated repository at study completion. Study team will follow all rules and regulations of the funding agency, which can be found here: https://www.pcori.org/about/governance/pcoris-policy-data-management-and-data-sharing

Marco de tiempo para compartir IPD

At the time of publication of the research project's primary results in a peer-reviewed journal - for at least 7 years

Criterios de acceso compartido de IPD

A data requestor that submits a data request will be evaluated for its overall qualifications and experience (e.g., across a proposed team of specified individuals) to achieve the stated research purpose underlying the data request. Neither PCORI nor the Awardee investigators will provide technical assistance directly to data requestors. However, either party may provide input to the repository upon request.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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