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

NCT ID: NCT01357681

Last Updated: 2015-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-05-31

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.

Conditions

Huntington Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

(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.

Group Type: EXPERIMENTAL

(2)-epigallocatechin-3-gallate (EGCG)

Intervention Type: 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)

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

(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)

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Josef Priller

Prof. Dr. med; Director, Department of Neuropsychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josef Priller, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neuropsychiatry, Charité Universitätsmedizin Berlin, Germany

Locations

Department of Neuropsychiatry

Berlin, , Germany

Neurologische Klinik der Ruhr-Universität Bochum

Bochum, , Germany

Universitätsklinikum Ulm, Klinik für Neurologie

Ulm, , Germany

Countries

Germany

Other Identifiers

2010-023941-31

Identifier Type: -

Identifier Source: org_study_id