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| Sponsor: | Cooperative International Neuromuscular Research Group |
|---|---|
| Information provided by: | Cooperative International Neuromuscular Research Group |
| ClinicalTrials.gov Identifier: | NCT00033813 |
Purpose
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 |
|---|---|---|
|
Muscular Dystrophy, Duchenne |
Drug: Oxatomide (tinset) |
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 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
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00033813 History of Changes |
| Other Study ID Numbers: | KUL0401 |
| Study First Received: | April 10, 2002 |
| Last Updated: | November 15, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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Duchenne muscular dystrophy controlled 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 Oxatomide Histamine H1 Antagonists |
Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Allergic Agents Therapeutic Uses Anti-Asthmatic Agents Respiratory System Agents |