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

Conditions: relapsing-remitting multiple sclerosisICD classification: G35.1

Registration Number: EUCTR2006-006323-39-DE

Lead Sponsor: Charité-Universitätsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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.

Secondary Outcome Measures