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

Phase 1

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: R lipoic acid; Drug: oral lipoic acid (LA); Drug: lipoic acid (LA) with fish oil and LA without fish oil

• Registration Number: NCT00676156
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

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 Timeline

• Study Start: 2005-12
• Primary Completion: 2008-02
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-12
• Study Completion: 2008-11
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-02
• Last Update Posted: 2012-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C	R lipoic acid	This arm will include the study of a single dose of R enantiomer lipoic acid.
A	oral lipoic acid (LA)	This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid.
B	lipoic acid (LA) with fish oil and LA without fish oil	This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design.

Primary Outcome Measures

Name	Time	Method
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.	November 2008

Secondary Outcome Measures

Name	Time	Method
To study salivary LA concentrations corresponding to the serum levels.	November 2008

Trial Locations

Locations (1)

Oregon Health and Science University Multiple Sclerosis Dept.; 🇺🇸 Portland, Oregon, United States