Phase 1
Completed N=69
Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Source: ClinicalTrials.gov NCT00997438 ↗Enrolled (actual)
69
Serious AEs
1.5%
Results posted
Jan 2017
Primary outcomePrimary: Lipoic Acid Levels — 1376.14; 1609.07; 1428.05 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lipoic Acid Levels |
0.55; 0.7; 0.57 | — |
| PRIMARY cAMP Levels |
72.6; 79.1; 103.5 | — |
| SECONDARY RANTES Levels |
44905.8; 42593.8; 60578.5 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT00997438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.