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

This study is currently recruiting participants.
Verified March 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Josef Priller, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01357681
First received: May 19, 2011
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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. EGCG or placebo will be given orally to patients with HD in addition to pre-existing medications provided those are necessary.

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 Intervention Phase
Huntington Disease
 Drug: (2)-epigallocatechin-3-gallate (EGCG)
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 -

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

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 [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • UHDRS Motor Score [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
  • UHDRS Behavioural Score [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
  • UHDRS Functional Assessment [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
  • UHDRS Total Functional Capacity [ Time Frame: Screening, Month 12 ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
  • Depression (BDI) [ Time Frame: Screening, Month 1, Month 2, Month 3, Month 6, Month 9, Month12, Month 13 ] [ Designated as safety issue: No ]
  • Health-related Quality of Life: SF-36 [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
  • Subjective Well-Being: SWLS [ Time Frame: Month 0, Month 12, Month 13 ] [ Designated as safety issue: No ]
  • Affective Processing: PANAS [ Time Frame: Month 0, Month 12, Month 13 ] [ Designated as safety issue: No ]
  • Tonic and phasic Alertness [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
  • Global Cognition: Mini Mental State Examination [ Time Frame: Screening, Month 12, Month 13 ] [ Designated as safety issue: No ]
  • Quantitative evaluation of motor functions: Qmotor [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
  • Brain atrophy assessed by brain MRI [ Time Frame: 12 months ] Brain atrophy as assessed by MRI-VBM [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
  • Pharmacokinetics and tolerability of EGCG [ Time Frame: Month 1 - Month 12 ] [ Designated as safety issue: Yes ]
    assessment of side effects and determination of blood and csf levels of EGCG

  • Determination of huntingtin expression levels [ Time Frame: Screening - Month 13 ] [ Designated as safety issue: No ]
    Quantification of huntingtin in blood and CSF (optional)


Estimated Enrollment: 54
Study Start Date: September 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 AMG or MPG studies (three months before and during participation)
  • Pregnancy/ lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357681

Contacts
Contact: Josef Priller, MD josef.priller@charite.de
Contact: Patricia Panneck, MD patricia.panneck@charite.de

Locations
Germany
Department of Neuropsychiatry Recruiting
Berlin, Germany, 10117
Contact: Josef Priller, MD         josef.priller@charite.de    
Contact: Patricia C Panneck, MD         patricia.panneck@charite.de    
Principal Investigator: Josef Priller, MD            
Neurologische Klinik der Ruhr-Universität Bochum Recruiting
Bochum, Germany, 44791
Contact: Carsten Saft, MD         Carsten.Saft@ruhr-uni-bochum.de    
Principal Investigator: Carsten Saft, MD            
Universitätsklinikum Münster, Klinik für Neurologie Active, not recruiting
Münster, Germany, 48149
Universitätsklinikum Ulm, Klinik für Neurologie Recruiting
Ulm, Germany, 89081
Contact: Sigurd Süssmuth, MD         sigurd.suessmuth@uni-ulm.de    
Principal Investigator: Sigurd Süßmuth, MD            
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Josef Priller, MD Department of Neuropsychiatry, Charité Universitätsmedizin Berlin, Germany
  More Information

No publications provided

Responsible Party: Josef Priller, Prof. Dr. med; Director, Department of Neuropsychiatry, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01357681     History of Changes
Other Study ID Numbers: 2010-023941-31
Study First Received: May 19, 2011
Last Updated: March 14, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Huntington Disease
Cognition
Motor
Behaviour
Functional Capacity
 Quality of Life
Biomarker
MRI
Huntingtin
EGCG

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
 Mental Disorders
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013