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

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Vijayshree Yadav, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00676156
First received: May 7, 2008
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
May 7, 2008
November 2, 2012
December 2005
February 2008   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00676156 on ClinicalTrials.gov Archive Site
To study salivary LA concentrations corresponding to the serum levels. [ Time Frame: November 2008 ]
Same as current
Not Provided
Not Provided
 
A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis
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.

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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: oral lipoic acid (LA)
    A single 1200 mg dose of oral LA will be administered.
  • 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.
  • Drug: R lipoic acid
    A single oral dose of 1200mg R enantiomer LA will be administered.
  • Active Comparator: A
    This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid.
    Intervention: Drug: oral lipoic acid (LA)
  • Active Comparator: B
    This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design.
    Intervention: Drug: lipoic acid (LA) with fish oil and LA without fish oil
  • Active Comparator: C
    This arm will include the study of a single dose of R enantiomer lipoic acid.
    Intervention: Drug: R lipoic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2008
February 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00676156
OHSU IRB00001305
NCCAM 1K23 AT003258-01
No
Not Provided
Not Provided
Not Provided
Vijayshree Yadav, Oregon Health and Science University
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Vijayshree Yadav, MD Oregon Health and Science University
Oregon Health and Science University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP