Effects of EGCG (Epigallocatechin Gallate) in Chorea Huntington

INTERVENTION: Product Name: Sunphenon EGCG Product Code: Sunphenon EGCG Pharmaceutical Form: Capsule, hard Current Sponsor code: Sunphenon EGCG 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: Huntington´s Disease Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To assess efficacy of Sunphenon EGCG in patients with Huntington´s Disease Primary end point(s): Difference in the sum score of: Stroop colour‐word interference test, word fluency, and symbol digit modalities test (SDMT) after 12 months of treatment (verum vs placebo) Secondary Objective: To compare secondary clinical endpoints (scores) between the verum and the placebo group; To assess safety of Sunphenon EGCG in patients with Huntington´s Disease Timepoint(s) of evaluation of this end point: after 12 months of treatment (12 months after baseline) SECONDARY OUTCOME: Secondary end point(s): ‐ Huntington specific motoric function: UHDRS Motor Score ; ‐ Huntington specific behavioral function: UHDRS Behavioral Score ; ‐ Huntington specific funtioning of daily living: UHDRS Functional Assessement ; ‐ Huntington specific indepedance: UHDRS Indepedance ; ‐ Huntington specific performance: UHDRS Total ; ‐ safatey and tolerability Timepoint(s) of evaluation of this end point: after 12 months of treatment (12 months after baseline) INCLUSION CRITERIA: • Chorea Huntington (CAG repeats > 39) • UHDRS TFC > 5 • = 18 years • Stable medication 4 weeks before baseline • no further participation in other interventional trials during and 3 months before/after ETON trial 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54