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