Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II

Phase 2 Terminated 11 enrolled Louisiana State University Health Sciences Center in New Orleans National Center for Complementary and Integrative Health (NCCIH) · collab

Non-randomizedParallel-groupQuadruple-blindTreatment

Summary

The hypothesis is that Polyphenon E 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 year between people with MS treated with Polyphenon E at a dose of 400mg twice a day and people with MS treated with a matching sugar pill.

Timeline

Start: 2011-07
Primary completion: 2013-02
Completion: 2013-02

Publications

Lovera J, Ramos A, Devier D, Garrison V, Kovner B, Reza T, Koop D, Rooney W, Foundas A, Bourdette D. Polyphenon E, non-futile at neuroprotection in multiple sclerosis but unpredictably hepatotoxic: Phase I single group and phase II randomized placebo-controlled studies. J Neurol Sci. 2015 Nov 15;358(1-2):46-52. doi: 10.1016/j.jns.2015.08.006. Epub 2015 Aug 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sinecatechins	Unknown	400 mg	Oral

Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II

Summary

Timeline

Publications

Drugs

Indications