NCT02011451

Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis

Safety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Louisiana State University Health Sciences Center in New Orleans · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	95% Pure ECGC capsules 200mg	Theaphenon 95% 95% Pure EGCG
DRUG	Placebo Comparator:

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-03-01
• Completion: 2017-12-01
• First posted: 2013-12-13
• Last updated: 2016-09-26

Locations

1 site across 1 country: United States