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).
This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
200 mg twice daily, after 3 months 400 mg twice daily
2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily
NeuroCure Clinical Research Center, Charite University, Berlin
Berlin, Germany
Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin
Berlin, Germany
number of new T2 lesions on brain MRI performed after 18 months of Sunphenon treatment compared to baseline MRI in the verum arm versus placebo
Time frame: 18 months
development of brain atrophy under treatment with EGCG vs. placebo
Time frame: 18 months
Safety and tolerability
Time frame: 18 months
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