At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 10 enrolled
Drug / intervention
Polyphenon Edrug
Likely dose
Polyphenon E 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis
Louisiana State University Health Sciences Center in New Orleans·interventional·Posted Feb 4, 2009·Updated Jun 27, 2013
In Brief
A Phase 1 clinical trial evaluating Polyphenon E for Multiple Sclerosis. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited States
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedFeb 2009
Primary CompletionNov 2010
TodayJul 2026
First PostedFeb 4, 2009
Enrollment StartFeb 1, 2009
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.4 years ago
Interventions
Polyphenon Edrug
Polyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day.