The purpose of this study is to compare the effectiveness of three antioxidant regimens in treating the symptoms of multiple sclerosis (MS).

Condition	Treatment or Intervention	Phase
Multiple Sclerosis	Drug: Ginkgo biloba  Drug: Alpha-lipoic acid  Drug: Vitamin E/Selenium  Drug: Essential fatty acids	Phase I Phase II

Further Study Details: 

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.

Genders Eligible for Study:  Both

Criteria

Exclusion Criteria:

• Pregnant
• Other significant health problems

Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97207,  United States

Study chairs or principal investigators

Dr. Dennis Bourdette,  Principal Investigator,  VA Medical Center-Brooklyn   

Study ID Numbers:  1 P50 AT00066-01P1; 1 P50 AT00066-01
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010842
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08