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

NCT ID: NCT00676156

Last Updated: 2012-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Keywords

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multiple sclerosis lipoic acid LA pharmacokinetics immunological effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid.

Group Type ACTIVE_COMPARATOR

oral lipoic acid (LA)

Intervention Type DRUG

A single 1200 mg dose of oral LA will be administered.

B

This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design.

Group Type ACTIVE_COMPARATOR

lipoic acid (LA) with fish oil and LA without fish oil

Intervention Type DRUG

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.

C

This arm will include the study of a single dose of R enantiomer lipoic acid.

Group Type ACTIVE_COMPARATOR

R lipoic acid

Intervention Type DRUG

A single oral dose of 1200mg R enantiomer LA will be administered.

Interventions

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oral lipoic acid (LA)

A single 1200 mg dose of oral LA will be administered.

Intervention Type 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.

Intervention Type DRUG

R lipoic acid

A single oral dose of 1200mg R enantiomer LA will be administered.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Vijayshree Yadav

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vijayshree Yadav, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Science University Multiple Sclerosis Dept.

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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NCCAM 1K23 AT003258-01

Identifier Type: -

Identifier Source: secondary_id

OHSU IRB00001305

Identifier Type: -

Identifier Source: org_study_id