The hypothesis is that 95% pure EGCG can protect brain cells in patients with Multiple Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate (a chemical that reflects the number of neurons and their metabolism) over one six between people with MS treated with EGCG at a dose of 400mg twice a day and people with MS treated with a matching sugar pill.
This will be a double blind placebo controlled trial of Theaphenon 95% (95% pure Epigallo-catechin-galleate \[EGCG\]) as a treatment for MS. The primary outcome will be the changes in N-Acety-Aspartate (NAA) levels over six months. Secondary outcomes will be changes in brain atrophy over over six months. As an exploratory outcome we will correlate changes in NAA levels with free Plasma levels of EGCG 8 hours after the morning dose. Exploratory outcomes include disability progression by Expanded Disability Status Scale (EDSS), multiple sclerosis functional composite components and a cognitive test battery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Theaphenon 95% 95% Pure EGCG
LSU Health Sciences Center
New Orleans, Louisiana, United States
Rate of change in NAA levels adjusted for water content.
The rate of change will be calculated using all the time points available (baseline,3 and 6 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %cerebrospinal fluid (CSF) and % lesion volume as covariates. All the voxels available for each subject where estimates have a standard deviation(SD) \<30 will be used. A spatial anisotropic exponential covariance structure will be used.
Time frame: 6 months
Brain Atrophy
Difference between the two groups in brain atrophy as measured by SIENA
Time frame: 6 months
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