Clinical Trial

Tadalafil as Adjuvant Therapy for DMD

Active, Not Recruiting Phase 2/3
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Record status
This record was last updated February 27, 2025 (before its estimated September 5, 2025 completion). Its status may not reflect the trial's current state.
Summary
This project will assess the vascular responsiveness in leg muscles of boys with Duchenne muscular dystrophy (DMD) to one single dose of tadalafil, a common vasodilator drug, using non-invasive techniques (MRI or Doppler ultrasound) and exercise testing. These findings will provide proof of concept for a subsequent intervention study to demonstrate efficacy of longer-term tadalafil to counter sympathetic vasoconstriction and slow disease progression in DMD. It will also inform whether a group of patients do not respond to the drug.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-01-04; most recent amendment 2026-02-24.
Status change: Active, Not Recruiting → Completed 2025-12-03
Status change: Recruiting → Active, Not Recruiting 2024-11-04
Status change: Not Yet Recruiting → Recruiting 2022-02-28
Trial Details
NCT Number NCT05195775
Lead Sponsor University of Florida
Conditions Duchenne Muscular Dystrophy
Enrollment 25 participants
Start Date 2021-12-14
Primary Completion 2025-09-05 (estimated)
Study Completion 2025-09-05 (estimated)
Updated on ClinicalTrials.gov 2025-02-27