Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multi
Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- epigallocatechin-gallate (Sunphenon)
- Sunphenon
Placebo
- placebo
What it measured
Main measures
number of new T2 lesions on brain MRI performed after 18 months of Sunphenon treatment compared to baseline MRI in the verum arm versus placebo
18 months
MRI lesionsPrimary endpoint is the cumulative number of new T2-lesions on a brain MRI scan at study end compared to baseline in the Polyphenon E vs. placebo group.
MRI lesions
Other measures (2)
development of brain atrophy under treatment with EGCG vs. placebo
18 months
Brain volume lossSafety and tolerability
18 months
Safety
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
Inclusion criteria
* male and female subjects age 18 to 60 * relapsing-remitting course of MS * stable treatment with glatiramer acetate at least 6 months prior to inclusion
Exclusion criteria
* primary or secondary progressive forms of MS * clinically relevant heart, lung, liver, kidney diseases * regular hepatotoxic co-medication * drug addiction * alcohol abuse
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Hypothesis: Sunphenon, a green tea extract containing 95% egcg, given daily as oral medication over a period of 18 months has anti-inflammatory and neuroprotective properties in patients with relapsing-remitting multiple sclerosis as assessed by magnetic resonance imaging and clinical examination (EDSS and MSFC).
Papers
Results
Epigallocatechin Gallate in Relapsing-Remitting Multiple Sclerosis: 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
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History
Started
Sept 2007
Main results due
Nov 2012
Finished
Nov 2012