Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title: Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis

Status Recruiting

Clinical Trial Summary

The purpose of this study is to learn about how the antioxidant, lipoic acid, works in the body and how it may help in the management of relapsing remitting and secondary progressive multiple sclerosis. This study will compare how subject's and healthy volunteers bodies absorb and break down the supplement. This information may help in developing new therapies.

Subjects will be recruited through patients of investigators at Portland VA Medical Center (PVAMC), Oregon Health & Science University (OHSU), and the community using flyers and word of mouth.

The following will occur during screening:

• Medical History Questionnaire to include questions about drug and alcohol use

• Self Administered Expanded Disability Status Scale (EDSS) Questionnaire (MS participants only)

• Vital Signs (heart rate, respiratory rate, blood pressure) will be measured and recorded

• Physical Exam (MS participants only unless necessary, based on the Medical History Questionnaire or vital signs, to ensure participant safety)

• Neurological Exam (MS participants only unless necessary, based on the Medical History Questionnaire or vital signs, to ensure participant safety)

• Weight

• Urine pregnancy test, if applicable

• Anemia testing by finger stick (approximately 1 drop)

The rest of the study involves

• Blood draws before lipoic acid is given, 1 hour, 2 hours, 3 hours, 4 hours, 24 and 48 hours after LA is given (3 ½ tablespoons)

• Subjects will receive breakfast before they take LA

• Subjects will take 4 - 300 mg capsules of lipoic acid (LA) for a total of 1200mg with about 1 cup of water

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

• NCT number: NCT00997438
• Study type: Interventional
• Source: Portland VA Medical Center
• Contact: Daniel Carr, Ph.D.
• Phone: 503-721-7918
• Email: carrd@ohsu.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: August 2010
• Completion date: December 2012