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Natural Antioxidants in the Treatment of Multiple Sclerosis

NCT ID: NCT00010842

Last Updated: 2006-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2004-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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Ginkgo biloba

Intervention Type DRUG

Alpha-lipoic acid

Intervention Type DRUG

Vitamin E/Selenium

Intervention Type DRUG

Essential fatty acids

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Pregnant
* Other significant health problems
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Dr. Dennis Bourdette

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center-Brooklyn

Locations

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Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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P50AT000066-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P50AT000066-01P1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00009438

Identifier Type: -

Identifier Source: nct_alias