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Tadalafil as Adjuvant Therapy for DMD

StatusActive, Not Recruiting
PhasePhase 2/3
Started2021-12-14
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 27, 2025 (before its estimated September 5, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-07-20
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results) v9
Primary endpoints1 entry, revised
Percent IncreaseChange in Post-contractile BOLD Signal Relative to Resting Condition
2026-02-24
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats v8
Primary endpoints1 entry, revised
ChangePercent Increase in Post-contractile BOLD ResponseSignal AfterRelative Tadalafilto DosingResting Condition
2026-01-12
Study Status, Eligibility, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats v7
Eligibility criteria+15 characters
[...] adalafil (use of nitrates, alpha-adrenergic blockers, other PDE5Aphosphodiesterase 5A inhibitors)
2025-12-03
Active, Not Recruiting→Completed Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats v6
Trial statusActive, Not Recruiting→Completed
Primary completion dateestimated 2025-09-05→confirmed 2024-04-16
Completion dateestimated 2025-09-05→confirmed 2025-09-08
Enrollment targetestimated 25→confirmed 12
Study arms2→1
InterventionsTadalafil (Drug), Tadalafil (Drug)→Tadalafil (Drug)
Secondary endpoints-61 characters
Change in submaximal exercise capacity after tadalafil dosing
Primary endpoints2 to 1 entries
Change in postPost-contractile BOLD responseResponse afterAfter tadalafilTadalafil dosing Change in post-exercise hyperemia after tadalafil dosingDosing
Study description-523 characters
This project will target up to 25 ambulatory boys with DMD aged 7-1330 years. Because the vascular impact of tadalafil is immediat [...] e in post-exercise hyperemia using Doppler ultrasonography. We will also assess the functional impact of the drug through exercise testing. Patients will be randomized to undergo the above-mentioned a [...] ments with or without the study drug on two separate visits. Time function tests, MRI-based fat fraction and inflammation measurements will also be obtained in all patients, thus characterizing disease severity and provide a sampling of information on whether a subset o [...]
2025-02-26
Study Status v5
Primary completion date2025-01-20→2025-09-05
Completion date2025-01-20→2025-09-05
Show 4 earlier versions
2024-11-04
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-10-20→2025-01-20
Study sitesdetails revised at 1 of 1 site
2024-01-30
Study Status v3
Primary completion date2023-10-20→2024-10-20
Completion date2023-10-20→2025-01-20
2022-11-08
Study Status v2
Primary completion date2022-10→2023-10-20
Completion date2022-10→2023-10-20
2022-02-28
Not Yet Recruiting→Recruiting Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-01→confirmed 2021-12-14
Eligibility criteria-248 characters
[...] age of 7.0 years Ambulatory Exclusion Criteria: Older than 1213.0 years of age Contraindication to an MR examination (e.g. [...] ia, magnetic implants) Presence of unstable medical problems, significant concomitant illness including cardiomyopathy, uncontrolled seizure disorder, uncontrolled hypo or hypertension Presence of a secondary condition that impacts muscle funct [...] nitrates, alpha-adrenergic blockers, other PDE5A inhibitors) anti-hypertensive drugs or other medications known to modulate blood flow or muscle metabolism or inhibit or induce CYP3A4)
Secondary endpoints+61 characters
Change in submaximal exercise capacity after tadalafil dosing
Study description+44 characters
This project will target up to 25 ambulatory boys with DMD aged 7-1213 years. Because the vascular impact of tadalafil is immediat [...] e in post-exercise hyperemia using Doppler ultrasonography. We will also assess the functional impact of the drug through exercise testing. Patients will be randomized to undergo onethe ofabove-mentioned theseassessments non-invasivewith techniquesor duringwithout theirthe study visitdrug (toon avoidtwo subjectingseparate the participant to a very long study visit)visits. Time function tests, MRI-based fat fraction and inflammation measurements will also be obtained [...]
Study sitesdetails revised at 1 of 1 site
2022-01-04
Original filing
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) and exercise testing. 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. It will also inform whether a group of patients do not respond to the drug.
Trial Details
NCT Number NCT05195775
Lead Sponsor University of Florida
Conditions Duchenne Muscular Dystrophy
Enrollment 25 participants
Start Date 2021-12-14
Primary Completion 2025-09-05 (estimated)
Study Completion 2025-09-05 (estimated)
Updated on ClinicalTrials.gov 2025-02-27