Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II (POEMS)
|ClinicalTrials.gov Identifier: NCT01451723|
Recruitment Status : Terminated (Unusual high frequency of elevated liver function tests.)
First Posted : October 14, 2011
Results First Posted : March 14, 2014
Last Update Posted : March 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Polyphenon E Other: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 2 Randomized Placebo Controlled Trial of Polyphenon E in MS|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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
- Rate of Change in NAA Levels Adjusted for Water Content. [ Time Frame: 1 year ]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 ]Difference between the two groups in brain atrophy as measured by SIENA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451723
|United States, Louisiana|
|LSu Health Sciences Center|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||Jesus F Lovera, MD||LSUHSC-New Orleans|