NCT00799890

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Friedemann Paul · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Sunphenon EGCG	200-800mg (1-4 capsules)
DRUG	Placebo	1-4 capsules

Timeline

• Start date: 2009-05-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2008-12-01
• Last updated: 2021-07-29

Locations

1 site across 1 country: Germany