Multiple Sclerosis Clinical Trial
Official title:
Safety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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