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| Sponsor: | Cooperative International Neuromuscular Research Group |
|---|---|
| Information provided by: | Cooperative International Neuromuscular Research Group |
| ClinicalTrials.gov Identifier: | NCT00033189 |
Purpose
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 |
|---|---|---|
|
Muscular Dystrophy, Duchenne |
Drug: Coenzyme Q10 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Eligibility| 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
Contacts and Locations| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00033189 History of Changes |
| Other Study ID Numbers: | CNMC0301 |
| Study First Received: | April 8, 2002 |
| Last Updated: | November 15, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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duchenne dystrophy DMD clinical trial CINRG |
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Muscular Dystrophy, Duchenne Muscular Dystrophies Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Genetic Diseases, X-Linked |
Genetic Diseases, Inborn Coenzyme Q10 Ubiquinone Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Vitamins |