Sunphenon in Progressive Forms of Multiple Sclerosis

Friedemann Paul61 enrolled

Overview

The investigators hypothesize that an oral Sunphenon EGCg (Epigallocatechin-Gallat, EGCG) treatment is - due to its antiinflamatoric and neuroprotective potence - significantly more effective than an oral placebo treatment regarding following parameters: increase in brain atrophy, number of new T2-lesions in the cerebral magnetic resonance tomography, reduction of the NAA/Cr-ratio in MR-spectroscopy, progression of disability such as cognitive disorders in patients with MS.

The hypotheses of our study are: Sunphenon EGCg has an antiinflammatoric effect due to its impact on the T-cell-proliferation and the inhibition of the activity of NF-Kb. Sunphenon EGCg has a neuroprotective effect due to its antioxidative potence as a radical scavenger. A 30 month treatment with Sunphenon EGCg is safe and well-tolerated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Sunphenon EGCGDRUG

200-800mg (1-4 capsules)

PlaceboDRUG

1-4 capsules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary or secondary chronic progressive multiple sclerosis (ms) * EDSS 3-8 * Age 18-65 Exclusion Criteria: * Relapsing-remitting ms * Immunodulatoric or immunosuppressive therapy * pretreatment with Mitoxantron, Natalizumab, Rituximab, Azathioprin \<2 month before screening * pretreatment with Glairameracetat or beta-Interferons \<4 weeks before screening * signs of hepatic dysfunction * active ulcus ventriculi or duodeni * neoplasias if not cured \>1 year before screening

Locations (1)

Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center)

Berlin, Germany