Trial | NCT00799890  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    61
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.
Study Started
May 31
2009
Primary Completion
Mar 31
2016
Study Completion
Mar 31
2016
Last Update
Jul 29
2021

Drug Sunphenon EGCG

200-800mg (1-4 capsules)

  • Other names: Epigallo Catechin Gallate

Drug Placebo

1-4 capsules

Sunphenon Experimental

Placebo Placebo Comparator

Criteria 

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
No Results Posted