NCT05195775CompletedPhase 2/3
Tadalafil as Adjuvant Therapy for DMD
Tadalafil as an Adjuvant to Therapy for Duchenne Muscular Dystrophy
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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). 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 4 Jan 2022
- Start date
- 14 Dec 2021
- Primary completion date
- 16 Apr 2024
- Lead sponsor
- University of Florida
- Diseases
- Duchenne muscular dystrophy
- NCT number
- NCT05195775
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 12
- From 14 Dec 2021 to the primary completion date, 16 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to an MR examination (e.g. aneurysm clip, severe claustrophobia, magnetic implants)
- Contraindications to Tadalafil (use of nitrates, alpha-adrenergic blockers, other phosphodiesterase 5A inhibitors)
Other illness
- Presence of a secondary condition that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease)
Age
- Older than 13.0 years of age
Other
- Presence of unstable medical problems
Who the study is looking for
- Diagnosis of DMD confirmed by 1) clinical history with features before the age of five, 2) physical examination, 3) elevated serum creatine kinase level and 4) absence of dystrophin expression, as determined by immunostaining or Western blot (\<2%) and/or DNA confirmation of dystrophin mutation.
- Minimum entry age of 7.0 years
- Ambulatory
Age in the registry: 6 years to 13 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.