A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to learn about an investigational drug known as oral lipoic acid (LA) that may help treat multiple sclerosis. This study will measure how a person's body absorbs and breaks down the drug (pharmacokinetics) and will compare four different forms of the drug from four different manufacturers as well as LA in conjunction with fish oil.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Thioctic Acid

Criteria

Inclusion Criteria:

• Definite MS by McDonald's or Poser's criteria

• EDSS ≤ 7.5

• Age 18 to 80

Exclusion Criteria:

• No clinically significant MS exacerbation within 30 days of the screening

• No systemically administered corticosteroids within 30 days of study entry

• Patient not pregnant or breast feeding

• No LA in previous 2 weeks

• Not on anti-coagulants such as heparin, coumadin, or aspirin during study

• No other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events

• Inability to give informed consent

• Any condition which would make the patient, in the opinion of the investigator, unsuitable for the study