- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004646
Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
OBJECTIVES: I. Characterize the effect of prednisone on muscle protein metabolism in patients with Duchenne muscular dystrophy.
II. Determine whether prednisone changes levels of insulin-like growth factor 1, growth hormone, and insulin.
III. Characterize the effect of prednisone on muscle morphometry and muscle localization of utrophin.
IV. Compare the prednisone response in patients with Duchenne muscular dystrophy to that seen in normal individuals and in patients with facioscapulohumeral dystrophy.
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PROTOCOL ENTRY CRITERIA:
- Ambulatory males with Duchenne muscular dystrophy
- No medical/psychiatric contraindication to protocol therapy
- No requirement for regular use of prescription medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Robert Griggs, University of Rochester
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Muscular Disorders, Atrophic
- Muscular Dystrophies
- Muscular Dystrophy, Duchenne
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisone
Other Study ID Numbers
- 199/11695
- URMC-2251
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Duchenne Muscular Dystrophy
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Cairo UniversityCompletedMuscular Dystrophy, Duchenne TypeEgypt
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Medical University of GdanskRecruitingDuchenne Muscular Dystrophy (DMD)Poland
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ItalfarmacoCompletedDuchenne Muscular Dystrophy (DMD)Italy
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Santhera PharmaceuticalsTerminatedDuchenne Muscular Dystrophy (DMD)United States, Spain, Netherlands, Sweden, Germany, France, Belgium, United Kingdom, Italy, Ireland, Switzerland, Austria, Bulgaria, Hungary, Israel
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Sarepta Therapeutics, Inc.CompletedDuchenne Muscular Dystrophy (DMD)United States
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Hospital RudolfstiftungOesterreichische MuskelforschungCompletedCarrier of Duchenne Muscular DystrophyAustria
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General Hospital of Chinese Armed Police ForcesUnknownDuchenne Muscular Dystrophy (DMD)China
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Chaitanya Hospital, PuneUnknownMuscular Dystrophy | Duchenne Muscular Dystrophy,India
-
University of FloridaU.S. Army Medical Research and Development CommandRecruitingDuchenne Muscular Dystrophy (DMD)United States
-
PTC TherapeuticsCompletedNonsene Mutation Duchenne Muscular DystrophyUnited States
Clinical Trials on prednisone
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Merck KGaA, Darmstadt, GermanyCompleted
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University of South FloridaNational Heart, Lung, and Blood Institute (NHLBI); National Institute of Arthritis... and other collaboratorsActive, not recruitingVasculitis | Granulomatosis With Polyangiitis | Wegener GranulomatosisUnited States
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Rabin Medical CenterUnknown
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University of Alabama at BirminghamNational Institute of Neurological Disorders and Stroke (NINDS)CompletedMyasthenia GravisThailand, Canada, Germany, Italy, Netherlands, Brazil, United States, Argentina, Australia, Chile, Japan, Mexico, Poland, Portugal, South Africa, Spain, Taiwan, United Kingdom
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University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI); National Institute of Arthritis... and other collaboratorsActive, not recruitingGranulomatosis With PolyangiitisUnited States, Canada
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Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUnknown
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Fundación Pública Andaluza para la Investigación...Sociedad Andaluza de Trasplantes de Organos y TejidosCompletedRenal Transplant Rejection | Other Complication of Kidney TransplantSpain
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Prof. Tony hayek MDCompletedDiabetes | Atherosclerosis | DyslipidemiasIsrael
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Health Science Center of Xi'an Jiaotong UniversityUnknownFocal Segmental GlomerulosclerosisChina
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National Institute for Tuberculosis and Lung Diseases...SuspendedInterstitial Lung Disease | Lung Neoplasm MalignantPoland