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Natural Antioxidants in the Treatment of Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010842
First received: February 2, 2001
Last updated: August 17, 2006
Last verified: August 2006

February 2, 2001
August 17, 2006
September 1999
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Complete list of historical versions of study NCT00010842 on ClinicalTrials.gov Archive Site
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Natural Antioxidants in the Treatment of Multiple Sclerosis
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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: Ginkgo biloba
  • Drug: Alpha-lipoic acid
  • Drug: Vitamin E/Selenium
  • Drug: Essential fatty acids
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2004
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Exclusion Criteria:

  • Pregnant
  • Other significant health problems
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010842
P50 AT000066-01P1, P50 AT000066-01
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Dr. Dennis Bourdette VA Medical Center-Brooklyn
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP