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

25. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

600

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: 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.
Arzneimittel: 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.
Arzneimittel: 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

Arzneimittel: 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.
Arzneimittel: 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

Gerät: 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.
Arzneimittel: 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.
Arzneimittel: 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.
Arzneimittel: 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

Arzneimittel: 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.
Arzneimittel: 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)

Gerät: 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.
Gerät: 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.
Gerät: 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.
Arzneimittel: 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

Gerät: 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.
Arzneimittel: 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)

Gerät: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient-centered utility function as a measure for efficacy and tolerability
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain intensity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Michigan

Mitarbeiter

Patient-Centered Outcomes Research Institute

Ermittler

  • Hauptermittler: Brian Callaghan, MD, University of Michigan

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. August 2030

Studienabschluss (Geschätzt)

1. August 2031

Studienanmeldedaten

Zuerst eingereicht

25. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. August 2026

Zuerst gepostet (Tatsächlich)

31. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HUM00292431
  • BPS-2025C2-45514 (Andere Zuschuss-/Finanzierungsnummer: Patient-Centered Outcomes Research Institute (PCORI))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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