Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)

Charité University Medicine Berlin

Status and phase: Completed; Phase 2; Phase 1

Conditions: Relapsing-remitting Multiple Sclerosis

Treatments: Drug: epigallocatechin-gallate (Sunphenon); Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00525668

2006-006323-39

Details and patient eligibility

About

Hypothesis:

Sunphenon, a green tea extract containing 95% egcg, given daily as oral medication over a period of 18 months has anti-inflammatory and neuroprotective properties in patients with relapsing-remitting multiple sclerosis as assessed by magnetic resonance imaging and clinical examination (EDSS and MSFC).

Full description

This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.

Enrollment: 120 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male and female subjects age 18 to 60
• relapsing-remitting course of MS
• stable treatment with glatiramer acetate at least 6 months prior to inclusion

Exclusion criteria

• primary or secondary progressive forms of MS
• clinically relevant heart, lung, liver, kidney diseases
• regular hepatotoxic co-medication
• drug addiction
• alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

verum

Active Comparator group

Description:

Sunphenon plus glatiramer acetate

Treatment:

Drug: epigallocatechin-gallate (Sunphenon)

placebo

Active Comparator group

Description:

placebo plus glatiramer acetate

Treatment:

Drug: placebo