Multiple Sclerosis Clinical Trial
Official title:
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).
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.
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Allocation: Randomized, Primary Purpose: Treatment
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