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NCT Number: NCT01357681

Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study)

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.

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Neuropsychiatry, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chorea Huntington (CAG repeats >39)
  • UHDRS TFC >5
  • ≥18 years of age
  • Readiness and ability to take oral medication
  • Normal liver function laboratory test
  • Stable concomitant medication regimen > 4 weeks prior to Baseline
  • Motivation for women with childbearing potential to use highly efficient contraception

Exclusion criteria

  • Clinically relevant abnormal findings in the ECG, vital signs, physical examination or laboratory values at Screening,
  • Long-term treatment with potentially hepatoxic medication
  • Any unstable medical condition
  • BDI Depression score > 9 AND clinical diagnosis of depression
  • Suicidal tendencies
  • Cognitive dysfunction defined as a score < 23 in the Mini-Mental State Examination (MMSE) at Screening
  • Liver or renal disease
  • Schizophreniform psychosis within the last 6 months before baseline
  • Consumption of more than two cups of black tea per day, consumption of green tea, consumption of > 500 ml /day of grapefruit juice
  • Participation in other Arzneimittelgesetz (AMG) or Medizinproduktegesetz (MPG) studies (three months before and during participation)
  • Pregnancy/ lactation

Treatment and study plan

(2)-epigallocatechin-3-gallate (EGCG)

Drug

Month 01:400 mg /day (200-0-200) Month 02:800 mg /day (400-0-400) Month 03 -12: 1200 mg /day (600-0-600)

Placebo

Drug

Placebo

Primary outcomes

  1. Change of cognitive functions (UHDRS-Cognition: composite score of Stroop test, Verbal fluency & Symbol Digit Modalities Test) after 12 months in comparison to baseline

    Time frame: Month 0, Month 12

Secondary outcomes

  1. UHDRS Motor Score

    Time frame: Month 0, Month 12

  2. UHDRS Behavioural Score

    Time frame: Month 0, Month 12

  3. UHDRS Functional Assessment

    Time frame: Month 0, Month 12

  4. UHDRS Total Functional Capacity (TFC)

    Time frame: Screening, Month 12

  5. Clinical Global Impression (CGI)

    Time frame: Month 0, Month 12

  6. Depression: Beck Depression Inventory (BDI)

    Time frame: Screening, Month 1, Month 2, Month 3, Month 6, Month 9, Month12, Month 13

  7. Health-related Quality of Life: Short Form (36) Health Survey (SF-36)

    Time frame: Month 0, Month 12

  8. Subjective Well-Being: Satisfaction With Life Scale (SWLS)

    Time frame: Month 0, Month 12, Month 13

  9. Affective Processing: Positive and Negative Affect Schedule (PANAS)

    Time frame: Month 0, Month 12, Month 13

  10. Tonic and phasic Alertness

    Time frame: Month 0, Month 12

  11. Global Cognition: Mini Mental State Examination

    Time frame: Screening, Month 12, Month 13

  12. Quantitative evaluation of motor functions: Qmotor

    Time frame: Month 0, Month 12

  13. Brain atrophy: assessed by magnetic resonance imaging (MRI)-voxel-based morphometry (VBM)

    Time frame: Month 0, Month 12

  14. Pharmacokinetics and tolerability of EGCG

    Time frame: Month 1 - Month 12

    assessment of side effects and determination of blood and cerebrospinal fluid (CSF) levels of EGCG

  15. Determination of huntingtin expression levels

    Time frame: Screening - Month 13

    Quantification of huntingtin in blood and CSF (optional)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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 -

Acronym: ETON

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 23, 2011
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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