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

Huntington Disease Clinical Trial

— 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 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357681
• Other study ID #: 2010-023941-31
• Status: Completed
• Phase: Phase 2
• First received: May 19, 2011
• Last updated: June 15, 2015
• Start date: September 2011
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease

Intervention

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
Placebo

Locations

Country	Name	City	State
Germany	Department of Neuropsychiatry	Berlin
Germany	Neurologische Klinik der Ruhr-Universität Bochum	Bochum
Germany	Universitätsklinikum Ulm, Klinik für Neurologie	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of cognitive functions (UHDRS-Cognition: composite score of Stroop test, Verbal fluency & Symbol Digit Modalities Test) after 12 months in comparison to baseline		Month 0, Month 12	No
Secondary	UHDRS Motor Score		Month 0, Month 12	No
Secondary	UHDRS Behavioural Score		Month 0, Month 12	No
Secondary	UHDRS Functional Assessment		Month 0, Month 12	No
Secondary	UHDRS Total Functional Capacity (TFC)		Screening, Month 12	No
Secondary	Clinical Global Impression (CGI)		Month 0, Month 12	No
Secondary	Depression: Beck Depression Inventory (BDI)		Screening, Month 1, Month 2, Month 3, Month 6, Month 9, Month12, Month 13	No
Secondary	Health-related Quality of Life: Short Form (36) Health Survey (SF-36)		Month 0, Month 12	No
Secondary	Subjective Well-Being: Satisfaction With Life Scale (SWLS)		Month 0, Month 12, Month 13	No
Secondary	Affective Processing: Positive and Negative Affect Schedule (PANAS)		Month 0, Month 12, Month 13	No
Secondary	Tonic and phasic Alertness		Month 0, Month 12	No
Secondary	Global Cognition: Mini Mental State Examination		Screening, Month 12, Month 13	No
Secondary	Quantitative evaluation of motor functions: Qmotor		Month 0, Month 12	No
Secondary	Brain atrophy: assessed by magnetic resonance imaging (MRI)-voxel-based morphometry (VBM)		Month 0, Month 12	No
Secondary	Pharmacokinetics and tolerability of EGCG	assessment of side effects and determination of blood and cerebrospinal fluid (CSF) levels of EGCG	Month 1 - Month 12	Yes
Secondary	Determination of huntingtin expression levels	Quantification of huntingtin in blood and CSF (optional)	Screening - Month 13	No