Huntington Disease Clinical Trial
Official title:
Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease The ETON-Study - A Randomized, Double-blind, Stratified, Placebo-controlled Prospective Investigator Initiated Multicenter Trial -
Huntington's disease (HD) is an inherited autosomal dominant, progressive neurodegenerative
disease. Clinically, HD is characterized by a triad of movement disorders, cognitive
impairments and psychiatric disturbances. These symptoms represent a tremendous burden for
patients and caregivers. HD is a fatal disorder with neither cure, nor evidence-based
standard therapy available.
The green tea polyphenon (2)-epigallocatechin-3-gallate (EGCG) was shown to have beneficial
effects in cell and animal models of HD. The aim of this study is to evaluate the efficacy
and tolerability of EGCG in HD.
The investigators hypothesize that Sunphenon EGCG administered at a maximal daily dose of
1200 mg compared to placebo during a period of 12 months improves cognition in patients with
HD. As primary outcome measure, the change of cognitive functions (as measured by the
Unified Huntington's Disease Rating Scale (UHDRS)-Cognition composite score of Stroop test,
Verbal fluency & Symbol Digit Modalities Test) after 12 months in comparison to Baseline was
defined.
The investigators further expect a positive influence of EGCG on other clinical
manifestations of HD, measurable effects of EGCG on HD biomarkers and good safety and
tolerability of EGCG in HD patients.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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