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

November 2, 2012 updated by: Vijayshree Yadav, Oregon Health and Science University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University Multiple Sclerosis Dept.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
November 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
To study salivary LA concentrations corresponding to the serum levels.
Time Frame: November 2008
November 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Vijayshree Yadav, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimate)

May 12, 2008

Study Record Updates

Last Update Posted (Estimate)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 2, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHSU IRB00001305
  • NCCAM 1K23 AT003258-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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