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NCT05195775
Tadalafil as Adjuvant Therapy for DMD
Phase 2, PHASE3 trial testing Tadalafil in Duchenne Muscular Dystrophy in 25 participants. Participants enrolled and being followed up; not accepting new ones.
5 September 2025
Quick facts
| Lead sponsor | University of Florida |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 14 December 2021 |
| Primary completion | 5 September 2025 |
| Estimated completion | 5 September 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Duchenne Muscular Dystrophy — all drugs for Duchenne Muscular Dystrophy →
Sponsor
University of Florida
Who can join
Adults 7 to 13, male only, with Duchenne Muscular Dystrophy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05195775
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials testing the same drug.
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- NCT06466369 — Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia · Phase 3 · completed
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Other recruiting trials for Duchenne Muscular Dystrophy
Currently open trials in the same condition.
- NCT07287189 — Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients · Phase 2 · recruiting
- NCT06817382 — A Study to Investigate the Safety and Biodistribution of a Single Intrathecal (IT) Injection of INS1201 in Ambulatory Ma · Phase 1 · recruiting
- NCT06402942 — Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy · NA · recruiting
- NCT06450639 — A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) · Phase 2 · active not recruiting
- NCT06692426 — Trial of Cell Based Therapy for DMD · Phase 1 · recruiting
Other University of Florida trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05195775 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Florida
- Last refreshed: 27 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05195775.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing