Natural Antioxidants in the Treatment of Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Natural Antioxidants in the Treatment of Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00010842
• Other study ID #: P50 AT000066-01P1
• Secondary ID: P50AT000066-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 2, 2001
• Last updated: August 17, 2006
• Start date: September 1999
• Est. completion date: December 2004

Study information

• Verified date: August 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Other known NCT identifiers

• NCT00009438

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Exclusion Criteria:

• Pregnant

• Other significant health problems

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Ginkgo biloba

• Alpha-lipoic acid

• Vitamin E/Selenium

• Essential fatty acids

Locations

Country	Name	City	State
United States	Oregon Health Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,