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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01357681
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Josef Priller, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE May 19, 2011
First Posted Date  ICMJE May 23, 2011
Last Update Posted Date June 16, 2015
Study Start Date  ICMJE September 2011
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2013)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
Change of cognitive functions (UHDRS-Cognition: composite score of Stroop test, Verbal fluency & Symbol Digit Modalities Test) after 12 months in comparison to [ Time Frame: Month 0, Month 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
  • UHDRS Motor Score [ Time Frame: Month 0, Month 12 ]
  • UHDRS Behavioural Score [ Time Frame: Month 0, Month 12 ]
  • UHDRS Functional Assessment [ Time Frame: Month 0, Month 12 ]
  • UHDRS Total Functional Capacity (TFC) [ Time Frame: Screening, Month 12 ]
  • Clinical Global Impression (CGI) [ Time Frame: Month 0, Month 12 ]
  • Depression: Beck Depression Inventory (BDI) [ Time Frame: Screening, Month 1, Month 2, Month 3, Month 6, Month 9, Month12, Month 13 ]
  • Health-related Quality of Life: Short Form (36) Health Survey (SF-36) [ Time Frame: Month 0, Month 12 ]
  • Subjective Well-Being: Satisfaction With Life Scale (SWLS) [ Time Frame: Month 0, Month 12, Month 13 ]
  • Affective Processing: Positive and Negative Affect Schedule (PANAS) [ Time Frame: Month 0, Month 12, Month 13 ]
  • Tonic and phasic Alertness [ Time Frame: Month 0, Month 12 ]
  • Global Cognition: Mini Mental State Examination [ Time Frame: Screening, Month 12, Month 13 ]
  • Quantitative evaluation of motor functions: Qmotor [ Time Frame: Month 0, Month 12 ]
  • Brain atrophy: assessed by magnetic resonance imaging (MRI)-voxel-based morphometry (VBM) [ Time Frame: Month 0, Month 12 ]
  • 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
  • Determination of huntingtin expression levels [ Time Frame: Screening - Month 13 ]
    Quantification of huntingtin in blood and CSF (optional)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
  • UHDRS Motor Score
  • UHDRS Behavioural Score
  • UHDRS Functional Assessment
  • UHDRS Total Functional Capacity
  • Clinical Global Impression (CGI)
  • Depression (BDI)
  • Health-related Quality of Life: SF-36
  • Subjective Well-Being: SWLS
  • Affective Processing: PANAS
  • Tonic and phasic Alertness
  • Global Cognition: Mini Mental State Examination
  • Quantitative evaluation of motor functions: Qmotor
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study)
Official Title  ICMJE Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease The ETON-Study - A Randomized, Double-blind, Stratified, Placebo-controlled Prospective Investigator Initiated Multicenter Trial -
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Huntington Disease
Intervention  ICMJE
  • 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)
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: (2)-epigallocatechin-3-gallate (EGCG)
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2011)
54
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01357681
Other Study ID Numbers  ICMJE 2010-023941-31
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Josef Priller, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Josef Priller, MD Department of Neuropsychiatry, Charité Universitätsmedizin Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP