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KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy Clinical research trials and KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy. KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy clinical trial. Test subjects oftentimes recieve the best healthcare possible for their KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "K" Clinical Trials Conditions > KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy  KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy
KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy
For Condition: Muscular Dystrophy, Duchenne
Status: Recruiting
Sponsor(s): Cooperative International Neuromuscular Research Group ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 5 Years/10 Years
Genders: Male
Protocol Entry Criteria: Subject Inclusion Criteria 1. 5 to 10 years of age 2. ambulatory 3. diagnosis of DMD confirmed by at least one of the following: - Positive x-linked family history of DMD in older male relatives (onset by 5 years, wheelchair bound by 12 years), or; - Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical DMD, or; - Gene deletion test positive (missing one or more exons) in the central rod domain (exons 25-60) of dystrophin, where reading frame can be predicted as ‘out of frame’, and clinical picture consistent with typical DMD. 4. glucocorticosteroid-naive (i.e. has not been treated with prednisone or deflazacort within the past year) 5. Evidence of muscle weakness by MRC score or clinical functional evaluation 6. QMT biceps score variability no greater than 10% between screening visits Subject Exclusion Criteria 1. Failure to achieve one or more of the inclusion criteria listed above 2. Inability to suitably cooperate with strength assessments 3. Symptomatic DMD carrier 4. Use of oxatomide (or other anti-histamine drugs) within the last 6 months for DMD or any other disease 5. Use of creatine monohydrate or glutamine within the last 6 months 6. Use of carnitine, Coenzyme Q10, other amino acids or any herbal medications within the last 3 months 7. History of symptomatic cardiomyopathy 8. History of impairment of hepatic function 9. History of significant concomitant illness or significant impairment of renal function.
Total Enrollment: 15
Location and Contact Information:
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010
United States
Recruiting Erik Henricson 202-884-3813
Additional Information:
Study ID Numbers: KUL0401;
Study Start Date: January 2002
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033813
Other Muscular Dystrophy, Duchenne Studies:
1. An open-label pilot study of Coenzyme Q10 in steroid-treated Duchenne muscular dystrophy
2. A multicenter randomized placebo-controlled double-blind study to assess efficacy and safety of glutamine and creatine monohydrate in Duchenne muscular dystrophy (DMD)
3. Creatine and Glutamine in Steroid-Naive Duchenne Muscular Dystrophy
4. KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy
Related Studies:
Other Muscular Dystrophy, Duchenne Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
KUL0401: An open-label pilot study of Oxatomide in steroid-naive Duchenne muscular dystrophy
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