Sunphenon (Epigallocatechin-Gallate) in relapsing-remitting multiple sclerosis - Sunphenon in RR-MS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006323-39-DE

Enrollment

100

Registered

2007-03-05

Start date

2007-06-19

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

relapsing-remitting multiple sclerosis ICD classification: G35.1

Interventions

Product Name: Sunphenon Pharmaceutical Form: Capsule, hard Other descriptive name: Sunphenon EGCg TM Concentration unit: mg milligram(s) Concentration number: 200- Pharmaceutical form of the placebo:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age 18 to 60, male and female subjects, confirmed diagnosis of relapsing-remitting multiple sclerosis according to the criteria by McDonald et al. revised in 2005, EDSS 0 to 6,5, immunomodulatory therapy with glatiramer acetate (Copaxone) for at least 9 months before screening. 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: primary or secondary chronic progressive multiple sclerosis, pregnancy, clinical or laboratory findings of impaired liver function, psychiatric disorders, concomitant medication with hepatotoxic drugs.

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluation of safety and efficacy of the dietary supplement Sunphenon (epigallocatechin gallate, green tea extract) given in a daily dose of 800mg over 1,5 years add-on to an immunomodulatory therapy with glatiramer acetate (Copaxone) in patients with relapsing-remitting multiple sclerosis. Primary endpoint is the cumulative number of new T2-lesions on a brain MRI scan at study end compared to baseline in the Sunphenon vs placebo group.;Secondary Objective: secondary endpoints are the changes in brain parenchymal fraction and the number of T1-lesions (back holes) on brain MRI scan, the number of relapses and change of cognitive functions over the entire study period. Regarding all secondary endpoints, the Polyphenon E group is compared with the placebo group.;Primary end point(s): Primary endpoint is the cumulative number of new T2-lesions on a brain MRI scan at study end compared to baseline in the Polyphenon E vs. placebo group.	—

Measure

Time frame

Main Objective: evaluation of safety and efficacy of the dietary supplement Sunphenon (epigallocatechin gallate, green tea extract) given in a daily dose of 800mg over 1,5 years add-on to an immunomodulatory therapy with glatiramer acetate (Copaxone) in patients with relapsing-remitting multiple sclerosis. Primary endpoint is the cumulative number of new T2-lesions on a brain MRI scan at study end compared to baseline in the Sunphenon vs placebo group.;Secondary Objective: secondary endpoints are the changes in brain parenchymal fraction and the number of T1-lesions (back holes) on brain MRI scan, the number of relapses and change of cognitive functions over the entire study period. Regarding all secondary endpoints, the Polyphenon E group is compared with the placebo group.;Primary end point(s): Primary endpoint is the cumulative number of new T2-lesions on a brain MRI scan at study end compared to baseline in the Polyphenon E vs. placebo group.

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Countries

Germany

Outcome results

None listed

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