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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Josef Priller, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01357681
First received: May 19, 2011
Last updated: April 14, 2014
Last verified: April 2014

May 19, 2011
April 14, 2014
September 2011
May 2015   (final data collection date for 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01357681 on ClinicalTrials.gov Archive Site
  • 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 (TFC) [ 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: Beck Depression Inventory (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: Short Form (36) Health Survey (SF-36) [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
  • Subjective Well-Being: Satisfaction With Life Scale (SWLS) [ Time Frame: Month 0, Month 12, Month 13 ] [ Designated as safety issue: No ]
  • Affective Processing: Positive and Negative Affect Schedule (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 magnetic resonance imaging (MRI)-voxel-based morphometry (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 cerebrospinal fluid (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)
  • UHDRS Motor Score [ Designated as safety issue: No ]
  • UHDRS Behavioural Score [ Designated as safety issue: No ]
  • UHDRS Functional Assessment [ Designated as safety issue: No ]
  • UHDRS Total Functional Capacity [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) [ Designated as safety issue: No ]
  • Depression (BDI) [ Designated as safety issue: No ]
  • Health-related Quality of Life: SF-36 [ Designated as safety issue: No ]
  • Subjective Well-Being: SWLS [ Designated as safety issue: No ]
  • Affective Processing: PANAS [ Designated as safety issue: No ]
  • Tonic and phasic Alertness [ Designated as safety issue: No ]
  • Global Cognition: Mini Mental State Examination [ Designated as safety issue: No ]
  • Quantitative evaluation of motor functions: Qmotor [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study)
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Huntington Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
54
July 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01357681
2010-023941-31
Yes
Josef Priller, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Josef Priller, MD Department of Neuropsychiatry, Charité Universitätsmedizin Berlin, Germany
Charite University, Berlin, Germany
April 2014

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