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| Sponsor: | National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00836719 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Polyphenon E |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis |
| Estimated Enrollment: | 10 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Polyphenon E: Experimental |
Drug: Polyphenon E
Polyphenon E capsules containing 200 mg of Epigallcachin-galleate. Two capsules twice a day.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jesus F Lovera, MD | 504 903 9302 | jlover@lsuhsc.edu |
| Contact: Nicolle Villemarette, PhD | 504-412-1517 | nville@lsuhsc.edu |
| United States, Louisiana | |
| Louisiana Health Sciences Center New Orleans | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Jesus Lovera, MD 504-903-9302 | |
| Principal Investigator: Jesus F Lovera, MD | |
| Sub-Investigator: Amparo Gutierrez, MD | |
| Sub-Investigator: Bridget Bagert, MD | |
More Information
| Responsible Party: | Louisiana State University Health Sciences Center New Orleans ( Jesus Lovera MD ) |
| Study ID Numbers: | K23 AT004433-01, 1K23AT004433-01 Pilot |
| Study First Received: | February 3, 2009 |
| Last Updated: | August 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00836719 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple sclerosis safety open label Polyphenon E |
EGCG NAA N-acetyl-aspartate MRI |
|
Pathologic Processes Autoimmune Diseases Multiple Sclerosis Immune System Diseases Demyelinating Diseases |
Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Sclerosis Autoimmune Diseases of the Nervous System |