Back to resultsA Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
oral lipoic acid (LA)
lipoic acid (LA) with fish oil and LA without fish oil
R lipoic acid
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, lipoic acid, LA, pharmacokinetics, immunological effects
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
Sites / Locations
- Oregon Health and Science University Multiple Sclerosis Dept.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
A
B
C
Arm Description
This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid.
This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design.
This arm will include the study of a single dose of R enantiomer lipoic acid.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To study salivary LA concentrations corresponding to the serum levels.
Full Information
NCT ID
NCT00676156
First Posted
May 7, 2008
Last Updated
November 2, 2012
Sponsor
Oregon Health and Science University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00676156
Brief Title
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
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, lipoic acid, LA, pharmacokinetics, immunological effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid.
Arm Title
B
Arm Type
Active Comparator
Arm Description
This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design.
Arm Title
C
Arm Type
Active Comparator
Arm Description
This arm will include the study of a single dose of R enantiomer lipoic acid.
Intervention Type
Drug
Intervention Name(s)
oral lipoic acid (LA)
Intervention Description
A single 1200 mg dose of oral LA will be administered.
Intervention Type
Drug
Intervention Name(s)
lipoic acid (LA) with fish oil and LA without fish oil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
R lipoic acid
Intervention Description
A single oral dose of 1200mg R enantiomer LA will be administered.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To study salivary LA concentrations corresponding to the serum levels.
Time Frame
November 2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijayshree Yadav, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University Multiple Sclerosis Dept.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
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