A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 18 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Thioctic acid
What it measured
Main measures
To determine the pharmacokinetics of orally administered LA 1200 mg. This will assess the variability in bioavailability of LA and the feasibility of conducting a more focused PK assessment in future studies with LA.
November 2008
How the body handles the medicineFeasibility
Other measures (1)
To study salivary LA concentrations corresponding to the serum levels.
November 2008
Who could take part
MS (type not specified) · 18 to 80
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Dec 2005
Main results due
Feb 2008
Finished
Nov 2008
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