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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 Alternative Medicine (NCCAM)
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
  Purpose

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.


Condition Intervention Phase
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome 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. [ Time Frame: November 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study salivary LA concentrations corresponding to the serum levels. [ Time Frame: November 2008 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2005
Study Completion Date: November 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676156

Locations
United States, Oregon
Oregon Health and Science University Multiple Sclerosis Dept.
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Vijayshree Yadav, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Vijayshree Yadav, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00676156     History of Changes
Other Study ID Numbers: OHSU IRB00001305, NCCAM 1K23 AT003258-01
Study First Received: May 7, 2008
Last Updated: November 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
multiple sclerosis
lipoic acid
LA
pharmacokinetics
immunological effects

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Thioctic Acid
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013