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| Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00010842 |
Purpose
The purpose of this study is to compare the effectiveness of three antioxidant regimens in treating the symptoms of multiple sclerosis (MS).
| Condition | Intervention | Phase |
|
Multiple Sclerosis |
Drug: Ginkgo biloba Drug: Alpha-lipoic acid Drug: Vitamin E/Selenium Drug: Essential fatty acids |
Phase I Phase II |
| MedlinePlus related topics: | Antioxidants Multiple Sclerosis |
| ChemIDplus related topics: | Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Selenium Thioctic acid |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Natural Antioxidants in the Treatment of Multiple Sclerosis |
| Study Start Date: | September 1999 |
| Estimated Study Completion Date: | December 2004 |
Multiple sclerosis (MS) is an immune mediated disease of the central nervous system that affects over 350,000 Americans. T lymphocytes, macrophages and soluble mediators of inflammation cause demyelination and axonal injury in MS. Activated macrophages release nitric oxide and oxygen free radicals that cause demyelination and axonal injury in MS and experimental autoimmune encephalomyelitis (EAE). Natural antioxidants may favorably influence the course of MS by decreasing oxidative injury. Chronic relapsing EAE in mouse models is clinically and pathologically useful for testing potential therapies for MS.
This study will assess three natural antioxidant regimens for their potential as treatments for MS: Ginkgo biloba, alpha-lipoic acid/essential fatty acids, and vitamin E/selenium. The effects of each regimen will be compared to determine which regimen appears most effective at suppressing EAE and decreasing markers of oxidative injury in patients with MS. As part of this study, two smaller trials will be conducted. A Phase I/II trial in patients with MS will determine if the selected antioxidant regimen can decrease disease activity as detected with gadolinium-enhanced magnetic resonance imaging. The results of this study will serve as the basis for a Phase III trial to assess the long term effectiveness of natural antioxidant therapy in MS.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | P50 AT000066-01P1, P50 AT000066-01 |
| First Received: | February 2, 2001 |
| Last Updated: | August 17, 2006 |
| ClinicalTrials.gov Identifier: | NCT00010842 |
| Health Authority: | United States: Federal Government |
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