Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lipoic Acid
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion/Exclusion criteria for MS subjects.
Inclusion criteria:
- Adult at least 18 years of age able to provide informed consent
- Currently diagnosed with relapsing remitting or secondary progressive MS
Exclusion criteria:
- Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days
- History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes
- History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia)
- MS exacerbation within 30 days of study entry
- Systemically administered corticosteroids within 30 days of study entry
- Pregnant or breast-feeding
- Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study
- Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase the risk of subject experiencing adverse events
- Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
- Anemia as indicated by a POC hemoglobin <12
- Subjects of child bearing potential or subjects capable of causing pregnancy who are sexually active and unwilling to use effective contraceptive methods for the duration of the study
Inclusion/ Exclusion criteria for healthy controls.
Inclusion criteria:
1) Adult at least 18 years of age able to provide informed consent
Exclusion criteria:
- Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days
- History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes
- History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia)
- Pregnant or breast-feeding
- Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study
- Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase the risk of subject experiencing adverse events
- Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
- Anemia as indicated by a POC hemoglobin <12
- Subjects of child bearing potential or subjects capable of causing pregnancy who are sexually active and unwilling to use effective contraceptive methods for the duration of the study
Sites / Locations
- Oregon Health & Science University
- Portland VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
MS - Secondary Progressive
MS - Relapsing Remitting
Healthy Controls
Arm Description
1200 mg of Lipoic acid supplement
1200mg of Lipoic acid supplement
1200 mg of Lipoic acid supplement
Outcomes
Primary Outcome Measures
Lipoic Acid Levels
Plasma concentration of LA
Lipoic Acid Levels
Plasma concentration of LA
Lipoic Acid Levels
Plasma concentration of LA
Lipoic Acid Levels
Plasma concentration of LA
Lipoic Acid Levels
Plasma concentration of LA
Lipoic Acid Levels
Plasma concentration of LA
cAMP Levels
cAMP Levels
Secondary Outcome Measures
RANTES Levels
RANTES Levels
Full Information
NCT ID
NCT00997438
First Posted
October 16, 2009
Last Updated
November 30, 2016
Sponsor
Portland VA Medical Center
Collaborators
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT00997438
Brief Title
Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Official Title
Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Portland VA Medical Center
Collaborators
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Subjects (healthy control, relapsing remitting MS and secondary progressive MS) 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
Blood will be processed to obtain plasma (from which lipoic acid concentrations will be measured) and PBMCs (from which cAMP and cytokines/chemokines will be measured).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MS - Secondary Progressive
Arm Type
Experimental
Arm Description
1200 mg of Lipoic acid supplement
Arm Title
MS - Relapsing Remitting
Arm Type
Experimental
Arm Description
1200mg of Lipoic acid supplement
Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
1200 mg of Lipoic acid supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Lipoic Acid
Intervention Description
300 mg Lipoic acid tablets from Vital Nutrients
Primary Outcome Measure Information:
Title
Lipoic Acid Levels
Description
Plasma concentration of LA
Time Frame
1 hour
Title
Lipoic Acid Levels
Description
Plasma concentration of LA
Time Frame
2 hours
Title
Lipoic Acid Levels
Description
Plasma concentration of LA
Time Frame
3 hours
Title
Lipoic Acid Levels
Description
Plasma concentration of LA
Time Frame
4 hours
Title
Lipoic Acid Levels
Description
Plasma concentration of LA
Time Frame
24 hour
Title
Lipoic Acid Levels
Description
Plasma concentration of LA
Time Frame
48 hour
Title
cAMP Levels
Time Frame
2 hours
Title
cAMP Levels
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
RANTES Levels
Time Frame
24 hour
Title
RANTES Levels
Time Frame
48 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion/Exclusion criteria for MS subjects.
Inclusion criteria:
Adult at least 18 years of age able to provide informed consent
Currently diagnosed with relapsing remitting or secondary progressive MS
Exclusion criteria:
Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days
History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes
History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia)
MS exacerbation within 30 days of study entry
Systemically administered corticosteroids within 30 days of study entry
Pregnant or breast-feeding
Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study
Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase the risk of subject experiencing adverse events
Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
Anemia as indicated by a POC hemoglobin <12
Subjects of child bearing potential or subjects capable of causing pregnancy who are sexually active and unwilling to use effective contraceptive methods for the duration of the study
Inclusion/ Exclusion criteria for healthy controls.
Inclusion criteria:
1) Adult at least 18 years of age able to provide informed consent
Exclusion criteria:
Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days
History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes
History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia)
Pregnant or breast-feeding
Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study
Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase the risk of subject experiencing adverse events
Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
Anemia as indicated by a POC hemoglobin <12
Subjects of child bearing potential or subjects capable of causing pregnancy who are sexually active and unwilling to use effective contraceptive methods for the duration of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Carr, Ph.D
Organizational Affiliation
Portland VA Medical Center and Oregon Health & Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29143287
Citation
Fiedler SE, Yadav V, Kerns AR, Tsang C, Markwardt S, Kim E, Spain R, Bourdette D, Salinthone S. Lipoic Acid Stimulates cAMP Production in Healthy Control and Secondary Progressive MS Subjects. Mol Neurobiol. 2018 Jul;55(7):6037-6049. doi: 10.1007/s12035-017-0813-y. Epub 2017 Nov 15.
Results Reference
derived
Learn more about this trial
Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
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