SUNIMUD - Sunphenon EGCg (Epigallocatechin-Gallate) in Duchenne Muscular Dystrophy
- Conditions
- Duchenne Muscular DystrophyTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2009-016482-28-DE
- Lead Sponsor
- Charite Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 40
•Duchenne Muscular Dystrophy
•Male patients > 4 years
•ability to walk without help (a minimum of 75 meters)
•maximum 2 cups of black tea, no consumption of grean tee, no consumption of greater amounts of grapefriut juice
•Informed consent of parents
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•serious other organic disease
•known intolerance of Sunphenon
•massiv and protracted exposure to sun
•participation in other interventional clinical trials on pharmaceuticals or medical devices during the study or 3 months before
•futher primary psychiatric/neurologic disorders
•known allergy against Sunphenon EGCg or additives of the study medication or placebo capsules
•longterm intake of liver toxic medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess safety and efficacy of Sunphenon EGCG in patients with Duchenne Muscular Dystrophy<br>;Secondary Objective: To compare secondary clinical endpoints between the verum and the placebo group <br>;Primary end point(s): - Adverse events and GHDL values (Verum vs Placebo, Months 0-12 and Months 12-36)<br>- 6 Minutes Walking Test (Differenz between Month 0 and 36);Timepoint(s) of evaluation of this end point: after 12 and 36 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Progression (MRC Score, HAMA Score, Time funtion tests)<br>- Contractures (neutral-null-methode);Timepoint(s) of evaluation of this end point: after 36 months