Duchenne Muscular Dystrophy
Conditions
Interventions
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 f
Sponsors
Charite Universitätsmedizin Berlin
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and efficacy of Sunphenon EGCG in patients with Duchenne Muscular Dystrophy ;Secondary Objective: To compare secondary clinical endpoints between the verum and the placebo group ;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);Timepoint(s) of evaluation of this end point: after 12 and 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactSponsor Deputy
Charite
Outcome results
None listed