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

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ClinicalTrials.gov Identifier: NCT01357681
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : June 16, 2015
Information provided by (Responsible Party):
Josef Priller, Charite University, Berlin, Germany

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: (2)-epigallocatechin-3-gallate (EGCG) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 -
Study Start Date : September 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: (2)-epigallocatechin-3-gallate (EGCG)
Month 01:400 mg /day (200-0-200) p.o. Month 02:800 mg /day (400-0-400) p.o. Month 03 -12: 1200 mg /day (600-0-600) p.o.
Drug: (2)-epigallocatechin-3-gallate (EGCG)
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 Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357681

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Department of Neuropsychiatry
Berlin, Germany, 10117
Neurologische Klinik der Ruhr-Universität Bochum
Bochum, Germany, 44791
Universitätsklinikum Ulm, Klinik für Neurologie
Ulm, Germany, 89081
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Josef Priller, MD Department of Neuropsychiatry, Charité Universitätsmedizin Berlin, Germany
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Responsible Party: Josef Priller, Prof. Dr. med; Director, Department of Neuropsychiatry, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01357681    
Other Study ID Numbers: 2010-023941-31
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015
Keywords provided by Josef Priller, Charite University, Berlin, Germany:
Huntington Disease
Functional Capacity
Quality of Life
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Epigallocatechin gallate
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents