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Tadalafil + Exercise for Duchenne Muscular Dystrophy

Phase 2
Recruiting
Led By Tanja Taivassalo, Ph.D.
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of DMD confirmed by genetic report
Minimum entry age of 6.0 years old
Must not have
Presence of a secondary condition leading to developmental delay or impaired motor control (e.g., cerebral palsy) or previous history of unprovoked rhabdomyolysis
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 years.

Summary

This trial is looking at two different treatments to help with Duchenne muscular dystrophy. One treatment involves aerobic exercise to improve muscle function and cardiovascular health, while the other treatment involves using a medication called t

Who is the study for?
This trial is for boys diagnosed with Duchenne muscular dystrophy (DMD), confirmed by a genetic report, who are at least 6 years old and can walk. They must be on a stable glucocorticoid regimen for over three months.
What is being tested?
The study tests the effects of tadalafil, a vasodilator that improves blood flow, combined with aerobic exercise training to see if they improve muscle function and cardiovascular health in DMD patients.
What are the potential side effects?
Tadalafil may cause headaches, indigestion, back pain, muscle aches, flushing, or stuffy nose. Exercise might lead to fatigue or muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis of Duchenne Muscular Dystrophy is confirmed by a genetic report.
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I am at least 6 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition like cerebral palsy or a history of muscle breakdown without cause.
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I do not have severe heart issues, uncontrolled seizures, or blood pressure problems.
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I am not taking medication that affects blood flow or muscle metabolism.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cycling time to fatigue
Vascular responsiveness after muscle contraction to a single dose of tadalafil.
Secondary study objectives
Metabolic recovery
Neurology Quality of Life (NeuroQoL) pediatric lower extremity function
PROMIS parent proxy for physical activity
+18 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tadalafil and Exercise ArmExperimental Treatment2 Interventions
Participants receive tadalafil weight-dependent dosage to take daily for 6 months (26 weeks).
Group II: Placebo and Exercise ArmPlacebo Group2 Interventions
Participants receive a tadalafil placebo tablet matching the tadalafil weight-dependent dosage to take daily for 6 months (26 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tadalafil
2014
Completed Phase 4
~3280

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,462 Total Patients Enrolled
University of FloridaLead Sponsor
1,397 Previous Clinical Trials
767,010 Total Patients Enrolled
2 Trials studying Exercise
139 Patients Enrolled for Exercise
Tanja Taivassalo, Ph.D.Principal InvestigatorUniversity of Florida, College of Medicine, Department of Physiology and Aging
1 Previous Clinical Trials
24 Total Patients Enrolled
~33 spots leftby Nov 2026
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