Vasodilators and Exercise as Adjuvant Therapy for Duchenne Muscular Dystrophy (VASO-REx Study)
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 6
Healthy Volunteers: f
View:
• Diagnosis of DMD confirmed by genetic report
• Minimum entry age of 6.0 years old
• Ambulatory
• On stable glucocorticoid regimen (for \> 3 months)
Locations
United States
Florida
University of Florida Clinical and Translational Research Building
RECRUITING
Gainesville
Contact Information
Primary
Tanja Taivassalo, Ph.D.
ttaivassalo@ufl.edu
352-294-8748
Backup
Ruby Sullivan, MS
r.sullivan1@ufl.edu
352-294-5392
Time Frame
Start Date: 2024-06-05
Estimated Completion Date: 2026-11
Participants
Target number of participants: 50
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: University of Florida
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)