NCT01451723

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

Phase 2 Randomized Placebo Controlled Trial of Polyphenon E in MS

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Louisiana State University Health Sciences Center in New Orleans · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.
OTHER	Placebo	Matching placebo capsules

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-10-14
• Last updated: 2014-03-14
• Results posted: 2014-03-14

Locations

1 site across 1 country: United States