SUPREMES - Sunphenon in progressive forms of multiple sclerosis

INTERVENTION: Product Name: Sunphenon Pharmaceutical Form: Capsule, hard Other descriptive name: Sunphenon EGCg Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: primary and secondary progressive forms of multiple sclerosis Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To evaluate efficacy and safety of Sunphenon EGCg in progressive forms of multiple sclerosis after a 36 months treatment compared to the placebo‐group, primary outcome criteria being reduction of Brain Parenchymal Fraction (atrophy) Primary end point(s): Brain Parenchymal Fraction / atrophy after 36 months of treatment vs. placebo Secondary Objective: ‐ T2‐lesions (number and volume); ‐ T1 hypointensive lesions („black holes“); ‐ changes in the NAA/Cr ratio (spectroscopy); ‐ EDSS; ‐ cognitive functions and fatigue ; ‐ RNFL („retinal nerve fiber layer“) thickness (optic coherencetomography); ; Timepoint(s) of evaluation of this end point: month 0‐36; SECONDARY OUTCOME: Secondary end point(s): T2 leasion, T1 hypotensive leasion, EDSS, changes in NAA/Cr quotient in spectroscopy, cognitive disorders and fatigue ; RNFL thickness in OCT Timepoint(s) of evaluation of this end point: month 0‐36 ; INCLUSION CRITERIA: age 18‐65, primary or secondary progressive Multiple Sclerosis according to McDonald‐criteria, EDSS 3‐8, negative pregnancy test, use of highly effective methods of birth control in women with childbearing potential, informed consent, max. 4 cups of coffee and 2 cups of black tea daily, no consumption of grean tea or larger amounts of grapefruit juice, at least 30 days between the last relapse and screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8