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NCT00836719 · ClinicalTrials.gov registry record · Phase 1
Safety of Polyphenon E in Multiple Sclerosis Pilot Study
A Phase 1 study, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00836719 is a Phase 1 study that has completed, run by Louisiana State University Health Sciences Center in New Orleans. The registered enrollment target is 10 participants.
The verdict
NCT00836719, a Phase 1 study, has completed, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- DRUG Polyphenon E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2009-02 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00836719
The ClinicalTrials.gov registry entry for NCT00836719 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Louisiana State University Health Sciences Center in New Orleans, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Polyphenon E is the first listed.
NCT00836719 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00836719 about?
NCT00836719 is a clinical study titled "Safety of Polyphenon E in Multiple Sclerosis Pilot Study". 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 mark...
What is the current status of trial NCT00836719?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2009-02. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00836719?
The interventions under investigation include: Polyphenon E (DRUG).
Who is sponsoring clinical trial NCT00836719?
This trial is sponsored by Louisiana State University Health Sciences Center in New Orleans, which has 45 total clinical trials registered on ClinicalTrials.gov.
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