NCT00836719

Safety of Polyphenon E in Multiple Sclerosis Pilot Study

Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (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

This study is an open label 6 month study. All subjects will be treated with Polyphenon E (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be safety. Secondary outcomes are the change in NAA levels over 6 months as measured by MR-spectroscopy. NAA levels are a marker of neuronal function. We think that Polyphenon E will protect neurons and thus increase NAA levels.

Detailed description

Additional clinical data include changes in EDSS, MS functional composite and cognitive testing.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Polyphenon E	Polyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-02-04
• Last updated: 2013-06-27
• Results posted: 2013-06-27

Locations

1 site across 1 country: United States