Relapsing-remitting Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, inflammation, neurodegeneration, neuroprotection
Brief summary
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).
Detailed description
This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.
Interventions
DRUGepigallocatechin-gallate (Sunphenon)
200 mg twice daily, after 3 months 400 mg twice daily
DRUGplacebo
2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| development of brain atrophy under treatment with EGCG vs. placebo | 18 months |
| Safety and tolerability | 18 months |
Countries
Germany
Outcome results
None listed