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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: | NCT00033813 |
This study will help to determine the safety and efficacy of the mast cell stabilizer Oxatomide as a treatment for Duchenne muscular dystrophy (DMD). Boys with DMD who are enrolled in this study will should not have taken steroids to treat DMD for at least twelve months, and should not have taken any nutritional supplements for at least three months. Subjects will complete a 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 Oxatomide. Once Oxatomide 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 Oxatomide until the study is completed.
Condition | Intervention | Phase |
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Muscular Dystrophy, Duchenne |
Drug: Oxatomide (tinset) |
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 10 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Subject Inclusion Criteria
diagnosis of DMD confirmed by at least one of the following:
Subject Exclusion Criteria
Study ID Numbers: | KUL0401 |
Study First Received: | April 10, 2002 |
Last Updated: | April 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00033813 |
Health Authority: | United States: Food and Drug Administration |
Duchenne muscular dystrophy controlled clinical trial CINRG |
Oxatomide Muscular dystrophy, Duchenne and Becker type Histamine Muscular Dystrophies Muscular Diseases Becker's muscular dystrophy Muscular Disorders, Atrophic Musculoskeletal Diseases |
Neuromuscular Diseases Genetic Diseases, Inborn Muscular Dystrophy, Duchenne Genetic Diseases, X-Linked Histamine phosphate Duchenne muscular dystrophy Atrophy Muscular dystrophy |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Histamine Antagonists Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Anti-Asthmatic Agents Histamine Agents Histamine H1 Antagonists Anti-Allergic Agents Pharmacologic Actions |