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NCT01070511 · ClinicalTrials.gov registry record · Phase 4
Tadalafil in Becker Muscular Dystrophy
A Phase 4 study of Becker Muscular Dystrophy, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
- 2
- Study locations
NCT01070511 is a Phase 4 study of Becker Muscular Dystrophy that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 48 participants, below the 1,392-participant average among 12 other Becker Muscular Dystrophy trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01070511, a Phase 4 study of Becker Muscular Dystrophy, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
- 2
- Study locations
Study Summary
Summary for Patients: This study, funded by the Muscular Dystrophy Association, is intended to build on recent findings published in the journal Nature showing beneficial effects of tadalafil (also known as Cialis) in mice with an animal version of Duchenne and Becker muscular dystrophies. Only two doses of tadalafil improved muscle blood flow, allowing the dystrophic mice to perform more exercise with less muscle injury. This new short-term clinical trial will move the testing from animals to human patients with Becker muscular dystrophy and examine the effects of acute tadalafil dosing on muscle blood flow during a bout of exercise. Patients will take two doses of tadalafil prior to exercising. Then doctors will measure whether muscles receive increased blood flow and therefore are better protected during exercise. Scientific Hypothesis: In patients with Becker muscular dystrophy (particularly those with dystrophin gene mutations between exons 41-46), loss of sarcolemmal nitric oxide synthase engenders functional muscle ischemia and thus muscle edema after an acute bout of exercise. The investigators further hypothesize that PDE5A inhibition, which boosts nitric oxide-cGMP signaling, constitutes an effective new countermeasure for these patients.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tadalafil
Study Locations (2)
California
- Cedars-Sinai Medical Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01070511
The ClinicalTrials.gov registry entry for NCT01070511 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,392-participant average among 12 other Becker Muscular Dystrophy trials with a reported enrollment target (97% lower). The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Becker Muscular Dystrophy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01070511 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01070511 about?
NCT01070511 is a clinical study titled "Tadalafil in Becker Muscular Dystrophy". Summary for Patients: This study, funded by the Muscular Dystrophy Association, is intended to build on recent findings published in the journal Nature showing beneficial effects of tadalafil (also known as Cialis) in mice with an animal version of Duchenne and Becker muscular dystrophies. Only two ...
What is the current status of trial NCT01070511?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2010-01. Estimated completion is 2012-12.
What conditions does trial NCT01070511 study?
This clinical trial studies the following conditions: Becker Muscular Dystrophy.
What interventions are being tested in trial NCT01070511?
The interventions under investigation include: Placebo (DRUG), Tadalafil (DRUG).
Who is sponsoring clinical trial NCT01070511?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01070511 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Becker Muscular Dystrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
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The Duchenne Registry
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Biomarker Development for Muscular Dystrophies
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Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy
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-
CureDuchenne Link®: A Resource for Research
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-
Defining Endpoints in Becker Muscular Dystrophy
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Characterization of Clinical Skeletal and Cardiac Impairment in Carriers of DMD and BMD
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.