Natural Antioxidants in the Treatment of Multiple Sclerosis
The purpose of this study is to compare the effectiveness of three antioxidant regimens in treating the symptoms of multiple sclerosis (MS).
Drug: Ginkgo biloba
Drug: Alpha-lipoic acid
Drug: Vitamin E/Selenium
Drug: Essential fatty acids
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010842
|United States, Oregon|
|Oregon Health Sciences University|
|Portland, Oregon, United States, 97207|
|Principal Investigator:||Dr. Dennis Bourdette||VA Medical Center-Brooklyn|