Recruiting
Phase 2

Vasodilator & Exercise

Sponsor:

University of Florida

Code:

NCT06290713

Conditions

Duchenne Muscular Dystrophy

Duchenne Disease

Muscular Dystrophy

Muscular Dystrophy in Children

Vasodilation

Eligibility Criteria

Sex: Male

Age: 6+

Healthy Volunteers: Not accepted

Interventions

Tadalafil

Placebo

Exercise Training

Study Details

Brief summary:

Examining two strategies as potential adjuvant therapies for Duchenne muscular dystrophy (DMD); aerobic exercise training (to induce adaptations in skeletal muscle and improve cardiovascular health) and tadalafil, an FDA-approved vasodilator (to optimize blood flow and muscle perfusion which is impaired and often overlooked in DMD). Target: improved muscle function, vascular health, and DMD treatment.

Conditions

Duchenne Muscular Dystrophy

Duchenne Disease

Muscular Dystrophy

Muscular Dystrophy in Children

Vasodilation

Study ID

NCT06290713

Start date

Jun 5, 2024

Status verified date

Apr, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 6+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of DMD confirmed by genetic report
  • Minimum entry age of 6.0 years old
  • Ambulatory
  • On stable glucocorticoid regimen (for > 3 months)

Exclusion Criteria:

  • Contraindication to a Magnetic resonance Imaging examination (e.g. severe claustrophobia, magnetic implants, unable/unwilling to perform test)
  • Presence of unstable medical problems, including severe cardiomyopathy, left ventricular ejection fraction <45%, cardiac conduction abnormalities as evidenced on ECG, uncontrolled seizure disorder, uncontrolled hypo or hypertension
  • Presence of a secondary condition that impacts muscle function or muscle metabolism (e.g., myasthenia gravis, endocrine disorder, mitochondrial disease)
  • Presence of a secondary condition leading to developmental delay or impaired motor control (e.g., cerebral palsy) or previous history of unprovoked rhabdomyolysis
  • Contraindications to phosphodiesterase 5 inhibitors (use of nitrates, alpha-adrenergic blockers, other phosphodiesterase 5 inhibitors) or other medications known to modulate blood flow or muscle metabolism
  • Participation in currently approved FDA trials or other investigational clinical trials during the period of the study

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tadalafil and Exercise Arm

Participants receive tadalafil weight-dependent dosage to take daily for 6 months (26 weeks).

placebo comparator: Placebo and Exercise Arm

Participants receive a tadalafil placebo tablet matching the tadalafil weight-dependent dosage to take daily for 6 months (26 weeks).

Interventions

Tadalafil

Patients will be given either the intervention medication or a placebo (double-blinded, randomized trial) and will be asked to take the medication every day for 6 months in conjunction with weekly exercise sessions.

Placebo

Patients will be given either the intervention medication or a placebo (double-blinded, randomized trial) and will be asked to take the medication every day for 6 months in conjunction with weekly exercise sessions.

Exercise Training

The home-based cycling exercise training program is designed to improve muscle strength and endurance. Participants will engage in individualized exercise sessions up to four times per week, lasting up to 40 minutes each. Live video and heart rate monitoring will ensure proper exercise performance and allow for adjustments to the program throughout the study. The participants will receive the exercise equipment for use at home.

Primary outcome measure

  • Vascular responsiveness after muscle contraction to a single dose of tadalafil. [ Time Frame: up to 4 weeks after the completion of Visits 1 and 2 of Aim 1. ]
  • Cycling time to fatigue [ Time Frame: Baseline and 6 month follow-up visits of Aim 2. ]

Central Contacts and Locations

Central contacts

Tanja Taivassalo, Ph.D.

352-294-8748ttaivassalo@ufl.edu

Ruby Sullivan, MS

352-294-5392r.sullivan1@ufl.edu

Locations

University of Florida Clinical and Translational Research Building

Recruiting

Gainesville, Florida, United States, 32603

More Information

Sponsor

University of Florida

Last update posted

May 15, 2026

Last verified

Apr, 2026

Keywords

  • DMD
  • Tadalafil
  • Drug and Exercise Intervention
  • Treatment Strategy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-05-15.