Huntington DiseasePhase 2ETONNCT01357681
Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study)
A Phase 2 study testing (2)-epigallocatechin-3-gallate (EGCG) in people with Huntington Disease, run by Charite University, Berlin, Germany at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- (2)-epigallocatechin-3-gallate (EGCG)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 3 sitesGermany
- Study dates
- Sep 2011to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Department of Neuropsychiatry
Berlin, 10117
Neurologische Klinik der Ruhr-Universität Bochum
Bochum, 44791
Universitätsklinikum Ulm, Klinik für Neurologie
Ulm, 89081
About this study
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.
Read more
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.
- Conditions
- Huntington Disease
- Being tested
- (2)-epigallocatechin-3-gallate (EGCG), Placebo
- Keywords
- Huntington Disease, Cognition, Motor, Behaviour, Functional Capacity, Quality of Life, Biomarker, MRI, Huntingtin, EGCG
- Medical subject headings
- Huntington Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(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)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| (2)-epigallocatechin-3-gallate (EGCG) | Experimental | 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. Receives: Drug: (2)-epigallocatechin-3-gallate (EGCG) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cognitive functions (UHDRS-Cognition: composite score of Stroop test, Verbal fluency & Symbol Digit Modalities Test) after 12 months in comparison to baseline
Measured: Month 0, Month 12
Secondary outcomes (15)
UHDRS Motor Score
Measured: Month 0, Month 12
UHDRS Behavioural Score
Measured: Month 0, Month 12
UHDRS Functional Assessment
Measured: Month 0, Month 12
UHDRS Total Functional Capacity (TFC)
Measured: Screening, Month 12
Clinical Global Impression (CGI)
Measured: Month 0, Month 12
Depression: Beck Depression Inventory (BDI)
Measured: 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)
Measured: Month 0, Month 12
Subjective Well-Being: Satisfaction With Life Scale (SWLS)
Measured: Month 0, Month 12, Month 13
Affective Processing: Positive and Negative Affect Schedule (PANAS)
Measured: Month 0, Month 12, Month 13
Tonic and phasic Alertness
Measured: Month 0, Month 12
Global Cognition: Mini Mental State Examination
Measured: Screening, Month 12, Month 13
Quantitative evaluation of motor functions: Qmotor
Measured: Month 0, Month 12
Brain atrophy: assessed by magnetic resonance imaging (MRI)-voxel-based morphometry (VBM)
Measured: Month 0, Month 12
Pharmacokinetics and tolerability of EGCG
assessment of side effects and determination of blood and cerebrospinal fluid (CSF) levels of EGCG
Measured: Month 1 - Month 12
Determination of huntingtin expression levels
Quantification of huntingtin in blood and CSF (optional)
Measured: Screening - Month 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josef Priller, Charite University, Berlin, Germany
- Investigators
- Josef Priller, MD, Principal investigator, Department of Neuropsychiatry, Charité Universitätsmedizin Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357681
- Sponsor's protocol ID
- 2010-023941-31
- Acronym
- ETON
- Status last verified
- Jun 2015
- First submitted
- 19 May 2011
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 -
- ClinicalTrials.gov ID
- NCT01357681
- Acronym / sponsor ID
- ETON / 2010-023941-31
- Conditions
- Huntington Disease
- Keywords
- Huntington Disease, Cognition, Motor, Behaviour, Functional Capacity, Quality of Life, Biomarker, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (2)-epigallocatechin-3-gallate (EGCG) | Experimental | Drug: (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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chorea Huntington (CAG repeats >39)
- UHDRS TFC >5
- ≥18 years of age
- Readiness and ability to take oral medication
- Normal liver function laboratory test
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (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 | (2)-epigallocatechin-3-gallate (EGCG) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
15 secondary outcomes
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
Determination of huntingtin expression levels
Time frame: Screening - Month 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Priller, MD principal investigator
Department of Neuropsychiatry, Charité Universitätsmedizin Berlin, Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing (2)-epigallocatechin-3-gallate (EGCG) in people with Huntington Disease, run by Charite University, Berlin, Germany at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.