Back to resultsEffects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study) (ETON)
Primary Purpose
Huntington Disease
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
(2)-epigallocatechin-3-gallate (EGCG)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Huntington Disease focused on measuring Huntington Disease, Cognition, Motor, Behaviour, Functional Capacity, Quality of Life, Biomarker, MRI, Huntingtin, EGCG
Eligibility Criteria
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
Sites / Locations
- Department of Neuropsychiatry
- Neurologische Klinik der Ruhr-Universität Bochum
- Universitätsklinikum Ulm, Klinik für Neurologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
(2)-epigallocatechin-3-gallate (EGCG)
Placebo
Arm Description
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.
Placebo
Outcomes
Primary Outcome Measures
Change of cognitive functions (UHDRS-Cognition: composite score of Stroop test, Verbal fluency & Symbol Digit Modalities Test) after 12 months in comparison to baseline
Secondary Outcome Measures
UHDRS Motor Score
UHDRS Behavioural Score
UHDRS Functional Assessment
UHDRS Total Functional Capacity (TFC)
Clinical Global Impression (CGI)
Depression: Beck Depression Inventory (BDI)
Health-related Quality of Life: Short Form (36) Health Survey (SF-36)
Subjective Well-Being: Satisfaction With Life Scale (SWLS)
Affective Processing: Positive and Negative Affect Schedule (PANAS)
Tonic and phasic Alertness
Global Cognition: Mini Mental State Examination
Quantitative evaluation of motor functions: Qmotor
Brain atrophy: assessed by magnetic resonance imaging (MRI)-voxel-based morphometry (VBM)
Pharmacokinetics and tolerability of EGCG
assessment of side effects and determination of blood and cerebrospinal fluid (CSF) levels of EGCG
Determination of huntingtin expression levels
Quantification of huntingtin in blood and CSF (optional)
Full Information
NCT ID
NCT01357681
First Posted
May 19, 2011
Last Updated
June 15, 2015
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01357681
Brief Title
Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study)
Acronym
ETON
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 Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
Keywords
Huntington Disease, Cognition, Motor, Behaviour, Functional Capacity, Quality of Life, Biomarker, MRI, Huntingtin, EGCG
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
(2)-epigallocatechin-3-gallate (EGCG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
(2)-epigallocatechin-3-gallate (EGCG)
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
UHDRS Motor Score
Time Frame
Month 0, Month 12
Title
UHDRS Behavioural Score
Time Frame
Month 0, Month 12
Title
UHDRS Functional Assessment
Time Frame
Month 0, Month 12
Title
UHDRS Total Functional Capacity (TFC)
Time Frame
Screening, Month 12
Title
Clinical Global Impression (CGI)
Time Frame
Month 0, Month 12
Title
Depression: Beck Depression Inventory (BDI)
Time Frame
Screening, Month 1, Month 2, Month 3, Month 6, Month 9, Month12, Month 13
Title
Health-related Quality of Life: Short Form (36) Health Survey (SF-36)
Time Frame
Month 0, Month 12
Title
Subjective Well-Being: Satisfaction With Life Scale (SWLS)
Time Frame
Month 0, Month 12, Month 13
Title
Affective Processing: Positive and Negative Affect Schedule (PANAS)
Time Frame
Month 0, Month 12, Month 13
Title
Tonic and phasic Alertness
Time Frame
Month 0, Month 12
Title
Global Cognition: Mini Mental State Examination
Time Frame
Screening, Month 12, Month 13
Title
Quantitative evaluation of motor functions: Qmotor
Time Frame
Month 0, Month 12
Title
Brain atrophy: assessed by magnetic resonance imaging (MRI)-voxel-based morphometry (VBM)
Time Frame
Month 0, Month 12
Title
Pharmacokinetics and tolerability of EGCG
Description
assessment of side effects and determination of blood and cerebrospinal fluid (CSF) levels of EGCG
Time Frame
Month 1 - Month 12
Title
Determination of huntingtin expression levels
Description
Quantification of huntingtin in blood and CSF (optional)
Time Frame
Screening - Month 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Priller, MD
Organizational Affiliation
Department of Neuropsychiatry, Charité Universitätsmedizin Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neuropsychiatry
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Neurologische Klinik der Ruhr-Universität Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitätsklinikum Ulm, Klinik für Neurologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
12. IPD Sharing Statement
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Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study)
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