Status:
COMPLETED
Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Lead Sponsor:
Portland VA Medical Center
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 sclerosi...
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 Univ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00997438
Start Date
August 1 2010
End Date
December 1 2013
Last Update
January 26 2017
Active Locations (2)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239
2
Portland VA Medical Center
Portland, Oregon, United States, 97239