Sunphenon in Progressive Forms of Multiple Sclerosis
Monocentric, Prospective, Doubleblind, Randomised/Stratified, Placebocontrolled Two-arm Study to Evaluate the Effect of Sunphenon EGCg (Main Component Epigallocatechin-Gallat) on the Increase of Brain Atrophy in the Cerebral Magnetic Resonance Tomography in a 36-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple Sclerosis
PhasePhase 2/Phase 3
Lead SponsorHumboldt University
StatusCompleted No Results Posted
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.
200-800mg (1-4 capsules)
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