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

25. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

600

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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
Eksperimentell: 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.
Legemiddel: 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
Eksperimentell: 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.
Legemiddel: 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

Legemiddel: 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)
Eksperimentell: 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.
Legemiddel: 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

Enhet: 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).
Eksperimentell: 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.
Legemiddel: 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)
Eksperimentell: 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.
Legemiddel: 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)
Eksperimentell: 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.
Legemiddel: 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

Legemiddel: 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)
Eksperimentell: 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.
Legemiddel: 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)

Enhet: 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).
Eksperimentell: 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.
Enhet: 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).
Eksperimentell: 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.
Enhet: 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).
Eksperimentell: 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.
Legemiddel: 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

Enhet: 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).
Eksperimentell: 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.
Legemiddel: 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)

Enhet: 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient-centered utility function as a measure for efficacy and tolerability
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain intensity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Michigan

Samarbeidspartnere

Patient-Centered Outcomes Research Institute

Etterforskere

  • Hovedetterforsker: Brian Callaghan, MD, University of Michigan

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. august 2030

Studiet fullført (Antatt)

1. august 2031

Datoer for studieregistrering

Først innsendt

25. august 2026

Først innsendt som oppfylte QC-kriteriene

25. august 2026

Først lagt ut (Faktiske)

31. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HUM00292431
  • BPS-2025C2-45514 (Annet stipend/finansieringsnummer: Patient-Centered Outcomes Research Institute (PCORI))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere