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Sponsored by: |
Cooperative International Neuromuscular Research Group |
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Information provided by: | Cooperative International Neuromuscular Research Group |
ClinicalTrials.gov Identifier: | NCT00033189 |
This study will help to determine the safety and efficacy of the nutritional supplement Coenzyme Q10 when added to steroids as a treatment for Duchenne muscular dystrophy (DMD). Boys with DMD who are enrolled in this study will should be on a stable dose of steroids for at least six months, and will remain on their usual dose throughout the study. They will complete two screening visits within a one-week period, and if enrolled will then have their strength tested monthly for three months before beginning therapy with Coenzyme Q10. Once Coenzyme Q10 therapy is started, participants will have their strength tested monthly for six months. Following the six month treatment period, participants will be given the option to remain on Coenzyme Q10 until the study is completed.
Condition | Intervention | Phase |
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Muscular Dystrophy, Duchenne |
Drug: Coenzyme Q10 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 5 Years to 11 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Subject Inclusion Criteria
Diagnosis of DMD confirmed by at least one the following:
Subject Exclusion Criteria
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 | |
United States, Missouri | |
Washington University-St. Louis | |
St. Louis, Missouri, United States, 63110 |
Study ID Numbers: | CNMC0301 |
Study First Received: | April 8, 2002 |
Last Updated: | April 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00033189 |
Health Authority: | United States: Food and Drug Administration |
duchenne dystrophy DMD clinical trial CINRG |
Muscular dystrophy, Duchenne and Becker type Coenzyme Q10 Muscular Dystrophies Muscular Diseases Becker's muscular dystrophy Muscular Disorders, Atrophic Musculoskeletal Diseases Neuromuscular Diseases |
Genetic Diseases, Inborn Muscular Dystrophy, Duchenne Ubiquinone Genetic Diseases, X-Linked Duchenne muscular dystrophy Atrophy Muscular dystrophy |
Vitamins Growth Substances Physiological Effects of Drugs |
Nervous System Diseases Micronutrients Pharmacologic Actions |