| May 7, 2008 |
| May 7, 2008 |
| December 2005 |
| February 2008 (final data collection date for primary outcome 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. [ Time Frame: November 2008 ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
| To study salivary LA concentrations corresponding to the serum levels. [ Time Frame: November 2008 ] [ Designated as safety issue: No ] |
| Same as current |
| |
| A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis |
| A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis |
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. |
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. |
| Phase I |
| Interventional |
| Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study |
| Multiple Sclerosis |
- Drug: oral lipoic acid (LA)
- Drug: lipoic acid (LA) with fish oil and LA without fish oil
- Drug: R lipoic acid
|
- Active Comparator: This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid.
- Active Comparator: This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design.
- Active Comparator: This arm will include the study of a single dose of R enantiomer lipoic acid.
|
| |
| |
| Active, not recruiting |
| 40 |
| November 2008 |
| February 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00676156 |
| Vijayshree Yadav, MD, OHSU |
| OHSU IRB00001305, NCCAM 1K23 AT003258-01 |
| Oregon Health and Science University |
| National Center for Complementary and Alternative Medicine (NCCAM) |
| Principal Investigator: |
Vijayshree Yadav, MD |
Oregon Health and Science University |
|
|
| Oregon Health and Science University |
| May 2008 |
