Safety and Brain Protection Effects of the Green Tea Extract 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Safety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis|
- Rate of change in NAA levels adjusted for water content. [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Brain Atrophy [ Time Frame: 6 months ] [ Designated as safety issue: No ]Difference between the two groups in brain atrophy as measured by SIENA
|Study Start Date:||September 2015|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Experimental: 95% Pure ECGC capsules 200mg
95% Pure ECGC capsules 200mg three times a day with food for 6 months
Drug: 95% Pure ECGC capsules 200mg
Other Name: Theaphenon 95%
Placebo Comparator: Sugar pill
Matched placebo capsules
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02011451
|United States, Louisiana|
|LSU Health Sciences Center||Not yet recruiting|
|New Orleans, Louisiana, United States, 70112|
|Contact: Jesus F Lovera, MD 504-903-9302 firstname.lastname@example.org|
|Principal Investigator: Jesus F Lovera, MD|