Vasodilator and Exercise Study for DMD (VASO-REx)

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06290713
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tadalafil — DRUG
    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 — DRUG
    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 — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 5, 2024
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Florida Clinical and Translational Research BuildingGainesvilleFlorida32603-

Find similar trials in Gainesville, FL

By condition
Duchenne muscular dystrophy
By specialty
Pediatrics
By research site
University of Florida Clinical and Translational Research Building· Gainesville, FL

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