Natural Antioxidants in the Treatment of Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT00010842|
Recruitment Status : Completed
First Posted : February 5, 2001
Last Update Posted : August 18, 2006
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Ginkgo biloba Drug: Alpha-lipoic acid Drug: Vitamin E/Selenium Drug: Essential fatty acids||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Natural Antioxidants in the Treatment of Multiple Sclerosis|
|Study Start Date :||September 1999|
|Estimated Study Completion Date :||December 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010842
|United States, Oregon|
|Oregon Health Sciences University|
|Portland, Oregon, United States, 97207|
|Principal Investigator:||Dr. Dennis Bourdette||VA Medical Center-Brooklyn|