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

NCT01357681 | Completed Phase 2 DMC

• 1 other identifier: 2010-023941-31
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

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

Keywords

Huntington Disease; Cognition; Motor; Behaviour; Functional Capacity; Quality of Life; Biomarker; MRI; Huntingtin; EGCG

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• UHDRS Motor Score

  Month 0, Month 12

• UHDRS Behavioural Score

  Month 0, Month 12

• UHDRS Functional Assessment

  Month 0, Month 12

• UHDRS Total Functional Capacity (TFC)

  Screening, Month 12

• Clinical Global Impression (CGI)

  Month 0, Month 12

Study Arms (2)

(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.

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

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

(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)

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

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (3)

Department of Neuropsychiatry

Berlin, 10117, Germany

Location

Neurologische Klinik der Ruhr-Universität Bochum

Bochum, 44791, Germany

Location

Universitätsklinikum Ulm, Klinik für Neurologie

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Huntington Disease; Behavior

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Josef Priller, MD

  Department of Neuropsychiatry, Charité Universitätsmedizin Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med; Director, Department of Neuropsychiatry

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

DE (3)