Clinical Trial: Sunphenon in Progressive Forms of Multiple Sclerosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Charite University, Berlin, Germany
Current Primary Outcome: brain atrophy [ Time Frame: 36 months of treatment ]
Original Primary Outcome: brain atrophy [ Time Frame: after 30 months of treatment ]
Current Secondary Outcome:
- new T2 lesions [ Time Frame: 36 months of treatment ]
- reduction of the NAA/Cr-ratio in MR-spectroscopy [ Time Frame: 36 months of treatment ]
- progression of disability such as cognitive disorders [ Time Frame: 36 months of treatment ]
- number of AEs [ Time Frame: 36 months of treatment ]
Original Secondary Outcome:
- new T2 lesions [ Time Frame: after 30 months of treatment ]
- redution of the NAA/Cr-ratio in MR-spectroscopy [ Time Frame: after 30 months of treatment ]
- progression of disability such as cognitive disorders [ Time Frame: after 30 months of treatment ]
- safety and tolerability of verum treatment [ Time Frame: at every visit and inbetween ]
Information By: Charite University, Berlin, Germany
Dates:
Date Received: November 28, 2008
Date Started: May 2009
Date Completion:
Last Updated: March 21, 2016
Last Verified: January 2016