A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
|Multiple Sclerosis||Drug: oral lipoic acid (LA) Drug: lipoic acid (LA) with fish oil and LA without fish oil Drug: R lipoic acid||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis|
- 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. [ Time Frame: November 2008 ]
- To study salivary LA concentrations corresponding to the serum levels. [ Time Frame: November 2008 ]
|Study Start Date:||December 2005|
|Study Completion Date:||November 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Active Comparator: A
This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid.
Drug: oral lipoic acid (LA)
A single 1200 mg dose of oral LA will be administered.
Active Comparator: B
This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design.
Drug: lipoic acid (LA) with fish oil and LA without fish oil
Subjects will be randomized to receive either 1 dose of 1200 mg LA with fish oil and then will be crossed-over to receive 1 dose of 1200 LA without fish oil. There will be a 1-week wash out period between the cross over.
Active Comparator: C
This arm will include the study of a single dose of R enantiomer lipoic acid.
Drug: R lipoic acid
A single oral dose of 1200mg R enantiomer LA will be administered.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676156
|United States, Oregon|
|Oregon Health and Science University Multiple Sclerosis Dept.|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Vijayshree Yadav, MD||Oregon Health and Science University|