Effects of EGCG (Epigallocatechin Gallate) in Chorea Huntington

Phase 1

• Conditions: Huntington´s Disease; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-023941-31-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-17
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Chorea Huntington (CAG repeats > 39)
• UHDRS TFC > 5
• = 18 years
• Stable medication 4 weeks before baseline
• no further participation in other interventional trials during and 3 months before/after ETON trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

• any clinically significant deviation of lab values, vital signs or ECG at baseline
• long-term medication with hepatotoxic substances
• instable medical disorder
• cognitive deficits (MMSE-Score <23)
• BDI depression score > 9 or clinical diagnosis of depression
• other primary neurological disorder
• current alcohol or drug abuse
• known liver oder kidney disease
• known anemia
• pregnancy/lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess efficacy of Sunphenon EGCG in patients with Huntington´s Disease;Secondary Objective: To compare secondary clinical endpoints (scores) between the verum and the placebo group<br>To assess safety of Sunphenon EGCG in patients with Huntington´s Disease;Primary end point(s): Difference in the sum score of: Stroop colour-word interference test, word fluency, and symbol digit modalities test (SDMT) after 12 months of treatment (verum vs placebo);Timepoint(s) of evaluation of this end point: after 12 months of treatment (12 months after baseline)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Huntington specific motoric function: UHDRS Motor Score <br>- Huntington specific behavioral function: UHDRS Behavioral Score <br>- Huntington specific funtioning of daily living: UHDRS Functional Assessement<br>- Huntington specific indepedance: UHDRS Indepedance <br>- Huntington specific performance: UHDRS Total <br>- safatey and tolerability;Timepoint(s) of evaluation of this end point: after 12 months of treatment (12 months after baseline)