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

Multiple Sclerosis Clinical Trial

Official title:

A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676156
• Other study ID #: OHSU IRB00001305
• Secondary ID: NCCAM 1K23 AT003
• Status: Completed
• Phase: Phase 1
• First received: May 7, 2008
• Last updated: November 2, 2012
• Start date: December 2005
• Est. completion date: November 2008

Study information

• Verified date: November 2012
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• oral lipoic acid (LA)
A single 1200 mg dose of oral LA will be administered.
• 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.
• R lipoic acid
A single oral dose of 1200mg R enantiomer LA will be administered.

Locations

Country	Name	City	State
United States	Oregon Health and Science University Multiple Sclerosis Dept.	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To study salivary LA concentrations corresponding to the serum levels.		November 2008	No