Effects of EGCG (Epigallocatechin Gallate) in Chorea Huntington

Effects of EGCG (Epigallocatechin Gallate) in Chorea Huntington - ETON

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023941-31-DE

Enrollment

Registered

2011-03-17

Start date

2011-05-20

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington´s Disease

Interventions

Product Name: Sunphenon EGCG Product Code: Sunphenon EGCG Pharmaceutical Form: Capsule, hard Current Sponsor code: Sunphenon EGCG Other descriptive name: Sunphenon EGCG Concentration unit: mg milligra

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 9 or clinical diagnosis of depression • other primary neurological disorder • current alcohol or drug abuse • known liver oder kidney disease • known anemia • pregnancy/lactation

Design outcomes

Primary

Measure	Time frame
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 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)	—

Measure

Time frame

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 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)

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Secondary

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

Measure

Time frame

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

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026