Sunphenon in Progressive Forms of Multiple Sclerosis (SUPREMES)
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.
Primary or Secondary Chronic-progressive Multiple Sclerosis
Drug: Sunphenon EGCG
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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 30-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple Sclerosis|
- brain atrophy [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
- new T2 lesions [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
- reduction of the NAA/Cr-ratio in MR-spectroscopy [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
- progression of disability such as cognitive disorders [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
- safety and tolerability of verum treatment (number of AEs incl. safetylab values) [ Time Frame: assessed at every (unscheduled or scheduled) visit ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Drug: Sunphenon EGCG
200-800mg (1-4 capsules)
Other Name: Epigallo Catechin Gallate
|Placebo Comparator: Placebo||
Other Name: n.a.
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.
|Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center)|
|Berlin, Germany, 10117|
|Principal Investigator:||Friedemann Paul, Dr.||Charite University (NeuroCure Clinical Research Center)|