Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II (POEMS)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 2 Randomized Placebo Controlled Trial of Polyphenon E in MS|
- Rate of Change in NAA Levels Adjusted for Water Content. [ Time Frame: 1 year ] [ Designated as safety issue: No ]The rate of change will be calculated using all the time points available )baseline, 6 and 12 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %CSF and % lesion volume as covariates. All the voxels available for each subject where estimates have a SD <30 will be used. A spatial anysotropic exponential covariance structure will be used.
- Brain Atrophy [ Time Frame: 1 year ] [ Designated as safety issue: No ]Difference between the two groups in brain atrophy as measured by SIENA
|Study Start Date:||July 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Polyphenon E 400mg twice a day
Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.
Drug: Polyphenon E
Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food.
Placebo Comparator: Placebo
Matching placebo capsules.
Matching placebo capsules
This will be a double blind placebo controlled trial of Polyphenon E as a treatment for MS.
The primary outcome will be the changes in NAA levels over one year. Secondary outcomes will be changes in brain atrophy over one year. 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 EDSS, MS functional composite components and a cognitive test battery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451723
|United States, Louisiana|
|LSu Health Sciences Center|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||Jesus F Lovera, MD||LSUHSC-New Orleans|