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Natural Antioxidants in the Treatment of Multiple Sclerosis



Natural Antioxidants in the Treatment of Multiple Sclerosis

For Condition: Multiple Sclerosis
Status: Completed
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: The purpose of this study is to compare the effectiveness of three antioxidant regimens in treating the symptoms of multiple sclerosis (MS).
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.
Eligibility:
Study Type:  Interventional, Treatment, Randomized
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Exclusion Criteria: - Pregnant - Other significant health problems
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
Dr.Bourdette,  Principal Investigator,  VA Medical Center-Brooklyn

Oregon Health Sciences University
Portland,  Oregon,  97207
United States
 


Additional Information:
Study ID Numbers:  1 P50 AT00066-01P1;  1 P50 AT00066-01
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010842

Other Multiple Sclerosis Studies:
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2. Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS)

3. Comparison of safety and efficacy of tizanidine hydrochloride capsules versus Zanaflex® (tizanidine hydrochloride tablets) taken while in the fed state (just after a meal) and in the fasted state (before a meal) in patients with moderate to severe spasticity.

4. Safety of RG2077 in Patients With Multiple Sclerosis

5. Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis

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