Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
2 other identifiers
interventional
69
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-sclerosis
Started Aug 2010
Typical duration for phase_1 multiple-sclerosis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2009
CompletedFirst Posted
Study publicly available on registry
October 19, 2009
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
January 26, 2017
CompletedJanuary 26, 2017
November 1, 2016
3.3 years
October 16, 2009
September 30, 2016
November 30, 2016
Conditions
Outcome Measures
Primary Outcomes (8)
Lipoic Acid Levels
Plasma concentration of LA
1 hour
Lipoic Acid Levels
Plasma concentration of LA
2 hours
Lipoic Acid Levels
Plasma concentration of LA
3 hours
Lipoic Acid Levels
Plasma concentration of LA
4 hours
Lipoic Acid Levels
Plasma concentration of LA
24 hour
Lipoic Acid Levels
Plasma concentration of LA
48 hour
cAMP Levels
2 hours
cAMP Levels
4 hours
Secondary Outcomes (2)
RANTES Levels
24 hour
RANTES Levels
48 hour
Study Arms (3)
MS - Secondary Progressive
EXPERIMENTAL1200 mg of Lipoic acid supplement
MS - Relapsing Remitting
EXPERIMENTAL1200mg of Lipoic acid supplement
Healthy Controls
EXPERIMENTAL1200 mg of Lipoic acid supplement
Interventions
300 mg Lipoic acid tablets from Vital Nutrients
Eligibility Criteria
You may not qualify if:
- Adult at least 18 years of age able to provide informed consent
- Currently diagnosed with relapsing remitting or secondary progressive MS
- 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
- \) Adult at least 18 years of age able to provide informed consent
- Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Portland VA Medical Centerlead
- Oregon Health and Science Universitycollaborator
Study Sites (2)
Oregon Health & Science University
Portland, Oregon, 97239, United States
Portland VA Medical Center
Portland, Oregon, 97239, United States
Related Publications (1)
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.
PMID: 29143287DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sonemany Salinthone
- Organization
- VA Portland Health Care System
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Carr, Ph.D
Portland VA Medical Center and Oregon Health & Science University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Career Scientist
Study Record Dates
First Submitted
October 16, 2009
First Posted
October 19, 2009
Study Start
August 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 26, 2017
Results First Posted
January 26, 2017
Record last verified: 2016-11