SUNIMUD - Sunphenon EGCg (Epigallocatechin-Gallate) in Duchenne Muscular Dystrophy

INTERVENTION: Product Name: Sunphenon EGCG Pharmaceutical Form: Capsule, hard INN or Proposed INN: Sunphenon Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Duchenne Muscular Dystrophy Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: To assess safety and efficacy of Sunphenon EGCG in patients with Duchenne Muscular Dystrophy; Primary end point(s): ‐ Adverse events and GHDL values (Verum vs Placebo, Months 0‐12 and Months 12‐36); ‐ 6 Minutes Walking Test (Differenz between Month 0 and 36) Secondary Objective: To compare secondary clinical endpoints between the verum and the placebo group ; Timepoint(s) of evaluation of this end point: after 12 and 36 months SECONDARY OUTCOME: Secondary end point(s): ‐ Progression (MRC Score, HAMA Score, Time funtion tests) ; ‐ Contractures (neutral‐null‐methode) Timepoint(s) of evaluation of this end point: after 36 months INCLUSION CRITERIA: • 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