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

Tracking Information
First Submitted Date ICMJE	May 7, 2008
First Posted Date ICMJE	May 12, 2008
Last Update Posted Date	November 6, 2012
Study Start Date ICMJE	December 2005
Actual Primary Completion Date	February 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 7, 2008)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00676156 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 7, 2008)	To study salivary LA concentrations corresponding to the serum levels. [ Time Frame: November 2008 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
Official Title ICMJE	A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis
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 Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Multiple Sclerosis
Intervention ICMJE	Drug: oral lipoic acid (LA) A single 1200 mg dose of oral LA will be administered.; Drug: 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.; Drug: R lipoic acid A single oral dose of 1200mg R enantiomer LA will be administered.
Study Arms	Active Comparator: A This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid. Intervention: Drug: oral lipoic acid (LA); Active Comparator: B This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design. Intervention: Drug: lipoic acid (LA) with fish oil and LA without fish oil; Active Comparator: C This arm will include the study of a single dose of R enantiomer lipoic acid. Intervention: Drug: R lipoic acid
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 7, 2008)	40
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	November 2008
Actual Primary Completion Date	February 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00676156
Other Study ID Numbers ICMJE	OHSU IRB00001305; NCCAM 1K23 AT003258-01
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Vijayshree Yadav, Oregon Health and Science University
Study Sponsor ICMJE	Oregon Health and Science University
Collaborators ICMJE	National Center for Complementary and Integrative Health (NCCIH)
Investigators ICMJE	Principal Investigator: Vijayshree Yadav, MD Oregon Health and Science University
PRS Account	Oregon Health and Science University
Verification Date	November 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP