Clinical trial NCT00676156: A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
Official title: A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
lipoic acid
LA
pharmacokinetics
immunological effects
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: November 2008
Secondary outcomes:
measure: To study salivary LA concentrations corresponding to the serum levels.
timeFrame: November 2008
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University Multiple Sclerosis Dept.
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Vijayshree Yadav, MD
role: PRINCIPAL_INVESTIGATOR
References: