Treatment of Duchenne Muscular Dystrophy with Cyclosporine A - DMD-CsA

niversitätsklinikum FreiburgZentrum für Kinder- und Jugendmedizin0 个研究点目标入组 150 人开始时间: 2010年6月22日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Male patients, minimum age 5
•- Ability to walk independently (minimum 50 meters)
•- Proven diagnosis of duchenne muscular dystrophy:
•clinical symptoms, increase of CK (more than 10-fold), together with at least one of the following criteria:
•dystrophine immunofluorescence and/or
•immunoblot negative muscle biopsy;
•positive gene deletion for duchenne;
•positive family history (with proven duchenne dystrophy)
•- Cooperation concerning visits
•- Able to swallow study medication (capsules)
•- Parents´ written informed consent
•- Child´s written informed consent if able to understand meaning of the study

•- Preceding therapy of duchenne with steroids
•- Change of a medication or alimentary additive within the last 3 months
•- Intake of clenbuterol or other sympathicomimetic drugs within 3 months of study entry
•- Participation on another trial within the last 3 months
•- Contraindications against intake of csA: functional renal impairment (creatinine above 0.7 mg/dl), uncontrolled hypertension (blood pressure above 97 percentile), known allergy against csA, uncontrolled infectious diseases, malignant tumors, severe liver disease, hyperuricemia, hypo magnesemia, necessity of therapy with drugs interfering pharmacokinetically with csA
•- Contraindications against intake of prednisone: known anamnestic gastrointestinal bleeding, cataract, diabetes, uncontrolled hypertension, uncontrolled infectious diseases (tuberculosis, infections with herpes, systemic mycosis), pronounced osteoporosis, 8 weeks before or 2 weeks after vaccination, glaucoma

发起方

niversitätsklinikum FreiburgZentrum für Kinder- und Jugendmedizin