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
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Sunphenon EGCG
Placebo
- Placebo
What it measured
Main measures
brain atrophy
36 months of treatment
Brain volume loss
Other measures (4)
new T2 lesions
36 months of treatment
MRI lesionsreduction of the NAA/Cr-ratio in MR-spectroscopy
36 months of treatment
progression of disability such as cognitive disorders
36 months of treatment
Thinking and memorynumber of AEs
36 months of treatment
Who could take part
Progressive MS · 18 to 65 · EDSS 3 to 8
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Epigallocatechin Gallate in Progressive MS: A Randomized, Placebo-Controlled Trial.Neurol Neuroimmunol Neuroinflamm · 2021
Results
Tracking CNS and systemic sources of oxidative stress during the course of chronic neuroinflammation.Acta Neuropathol · 2015
Results
Klumbies K, Rust R, Dorr J, Konietschke F, Paul F, Bellmann-Strobl J, Brandt AU, Zimmermann HG. Retinal Thickness Analysis in Progressive Multiple Sclerosis Patients Treated With Epigallocatechin Gallate: Optical Coherence Tomography Results From the SUPREMES Study. Front Neurol. 2021 Apr 28;12:615790. doi: 10.3389/fneur.2021.615790. eCollection 2021.
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History
Started
May 2009
Main results due
Mar 2016
Finished
Mar 2016