Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Completed · Phase 1
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT00997438
- Run by
- Portland VA Medical Center
- People needed
- 69
- Starts
- 2010-08-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2017-01-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult at least 18 years of age able to provide informed consent
- Currently diagnosed with relapsing remitting or secondary progressive MS
You may not qualify if…
- 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:
- 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
Where it is running
- Oregon Health & Science University — Portland, Oregon, United States
- Portland VA Medical Center — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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