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

Study acronym: MCPAIN
StatusNot Yet Recruiting
PhasePhase 4
Started2026-10
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Aug 2030 → May 2031
See other at-risk trials from University of Michigan

Amendment history

2026-09-29
Primary completion pushed: 2030-08 → 2031-05
Completion pushed: 2031-08 → 2031-10
Start date pushed: 2026-09 → 2026-10
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.
Trial Details
NCT Number NCT07795593
Lead Sponsor University of Michigan
Collaborators: Patient-Centered Outcomes Research Institute
Conditions Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
Enrollment 600 participants
Start Date 2026-10
Primary Completion 2031-05 (estimated)
Study Completion 2031-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-28