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

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Drug: lipoic acid (LA) with fish oil and LA without fish oil; Drug: R lipoic acid; Drug: oral lipoic acid (LA)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00676156

NCCAM 1K23 AT003258-01

OHSU IRB00001305

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

A

Active Comparator group

Description:

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

Treatment:

Drug: oral lipoic acid (LA)

B

Active Comparator group

Description:

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

Treatment:

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

C

Active Comparator group

Description:

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

Treatment:

Drug: R lipoic acid