Safety of Polyphenon E in Multiple Sclerosis Pilot Study
This study is an open label 6 month study. All subjects will be treated with Polyphenon E (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be safety. Secondary outcomes are the change in NAA levels over 6 months as measured by MR-spectroscopy. NAA levels are a marker of neuronal function. We think that Polyphenon E will protect neurons and thus increase NAA levels.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis|
- Number of Participants Experiencing Serious Adverse Events [ Time Frame: six months ] [ Designated as safety issue: Yes ]
- Change in Brain NAA Level as Measured by MR Spectroscopy [ Time Frame: 6 months ] [ Designated as safety issue: No ]percent change from baseline to exit in NAA levels adjusted for creatine levels
|Study Start Date:||February 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: Polyphenon E
Standarized green tea extract containing 50% EGCG
Drug: Polyphenon E
Polyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day.
Additional clinical data include changes in EDSS, MS functional composite and cognitive testing.
|United States, Louisiana|
|Louisiana Health Sciences Center New Orleans|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||Jesus F Lovera, MD, MSPH||LSUHSC|