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An open-label pilot study of Coenzyme Q10 in steroid-treated Duchenne muscular dystrophy Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about An open-label pilot study of Coenzyme Q10 in steroid-treated Duchenne muscular dystrophy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. An open-label pilot study of Coenzyme Q10 in steroid-treated Duchenne muscular dystrophy Clinical research trials and An open-label pilot study of Coenzyme Q10 in steroid-treated Duchenne muscular dystrophy medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like An open-label pilot study of Coenzyme Q10 in steroid-treated Duchenne muscular dystrophy. An open-label pilot study of Coenzyme Q10 in steroid-treated Duchenne muscular dystrophy Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a An open-label pilot study of Coenzyme Q10 in steroid-treated Duchenne muscular dystrophy clinical trial. Test subjects typically obtain the finest healthcare available for their An open-label pilot study of Coenzyme Q10 in steroid-treated Duchenne muscular dystrophy condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > An open-label pilot study of Coenzyme Q10 in steroid-treated Duchenne muscular dystrophy  An open-label pilot study of Coenzyme Q10 in steroid-treated Duchenne muscular dystrophy
An open-label pilot study of Coenzyme Q10 in steroid-treated 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 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 5 Years/11 Years
Genders: Male
Protocol Entry Criteria: Subject Inclusion Criteria 1. Age: 5 - 11 years old 2. Ambulant 3. Diagnosis of DMD confirmed by at least one the following: - Positive X-linked family history for typical Duchenne muscular dystrophy in older male relatives (onset by age 5 yr., wheelchair-bound by age 12 yr.) OR - Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical Duchenne dystrophy 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 Duchenne dystrophy. 4. On Glucocorticosteroids: Children must be on a steady dose of prednisone or deflazacort, on any schedule (Daily, alternate days, 10 days on, 10 days off or twice a week), for the last 6 months before starting the clinical trial. Dose of steroid or schedule cannot be altered during the study. 5. Evidence of muscle weakness by MRC score or clinical functional evaluation 6. Ability to provide reproducible repeat QMT bicep score within 10% of first assessment score. 7. Ability to swallow tablets Subject Exclusion Criteria 1. Failure to achieve one or more of the diagnostic inclusion criteria cited above. 2. Symptomatic DMD carrier 3. Previous (6 months or less) or current use of Coenzyme Q10 (for DMD or any other disease) 4. Use of carnitine, other amino acids, creatine, glutamine, or any herbal medicines within the last 3 months. 5. History of significant concomitant illness or significant impairment of renal or hepatic function.
Total Enrollment: 15
Location and Contact Information:
Washington University-St. Louis *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Julaine Florence 314-362-6983
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: CNMC0301;
Study Start Date: September 2001
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033189
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
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An open-label pilot study of Coenzyme Q10 in steroid-treated Duchenne muscular dystrophy
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