Multiple Sclerosis Clinical Trial
A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
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.
Full Description
Multiple sclerosis (MS) is a common, often disabling inflammatory disease of the central nervous system (CNS). Present treatments for MS are only partially effective, available only in injectable forms, have significant side effects and are very costly. Developing more effective and better-tolerated treatments of MS thus remains an important goal for the improvement of the care of MS. Lipoic acid (LA) is an antioxidant that is widely available as a dietary supplement.
The primary outcome of this study is to determine the pharmacokinetics of oral LA 1200 mg to see if we can identify factors affecting the bioavailability of LA. We will also study the salivary concentrations of oral LA and its correlation with the serum LA concentrations. We will also study the effects of LA on the immunological markers after four hours of administration.
Eligibility 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
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There is 1 Location for this study
Portland Oregon, 97239, United States
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