Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Thioctic acid
Results by group
Lipoic Acid Levels
1 hour
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS - Secondary Progressive | 1376.14 ng/mL | 359.41 (Standard Error) | 15 |
| MS - Relapsing Remmitting | 1609.07 ng/mL | 312.47 (Standard Error) | 21 |
| Healthy Controls | 1428.05 ng/mL | 330.02 (Standard Error) | 19 |
MS - Secondary Progressive
MS - Relapsing Remmitting
Healthy Controls
Lipoic Acid Levels
2 hours
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS - Secondary Progressive | 1125.71 ng/mL | 291.4 (Standard Error) | 15 |
| MS - Relapsing Remmitting | 1167.33 ng/mL | 205.02 (Standard Error) | 21 |
| Healthy Controls | 1348 ng/mL | 205.91 (Standard Error) | 19 |
MS - Secondary Progressive
MS - Relapsing Remmitting
Healthy Controls
Lipoic Acid Levels
3 hours
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS - Secondary Progressive | 667.86 ng/mL | 138.24 (Standard Error) | 15 |
| MS - Relapsing Remmitting | 638.4 ng/mL | 114.41 (Standard Error) | 21 |
| Healthy Controls | 793.89 ng/mL | 173.39 (Standard Error) | 19 |
MS - Secondary Progressive
MS - Relapsing Remmitting
Healthy Controls
Lipoic Acid Levels
4 hours
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS - Secondary Progressive | 268.6 ng/mL | 73.15 (Standard Error) | 15 |
| MS - Relapsing Remmitting | 252.75 ng/mL | 33.85 (Standard Error) | 21 |
| Healthy Controls | 394.1 ng/mL | 129.15 (Standard Error) | 19 |
MS - Secondary Progressive
MS - Relapsing Remmitting
Healthy Controls
Lipoic Acid Levels
24 hour
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS - Secondary Progressive | 0.78 ng/mL | 0.13 (Standard Error) | 15 |
| MS - Relapsing Remmitting | 0.87 ng/mL | 0.05 (Standard Error) | 21 |
| Healthy Controls | 0.78 ng/mL | 0.06 (Standard Error) | 19 |
MS - Secondary Progressive
MS - Relapsing Remmitting
Healthy Controls
Lipoic Acid Levels
48 hour
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS - Secondary Progressive | 0.55 ng/mL | 0.15 (Standard Error) | 15 |
| MS - Relapsing Remmitting | 0.7 ng/mL | 0.05 (Standard Error) | 21 |
| Healthy Controls | 0.57 ng/mL | 0.04 (Standard Error) | 19 |
MS - Secondary Progressive
MS - Relapsing Remmitting
Healthy Controls
cAMP Levels
2 hours
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS - Secondary Progressive | 75.9 pmol cAMP/mg protein | 46–101.5 | 16 |
| MS - Relapsing Remmitting | 75.8 pmol cAMP/mg protein | 56.8–113 | 19 |
| Healthy Controls | 96.6 pmol cAMP/mg protein | 75.1–129.2 | 19 |
MS - Secondary Progressive
MS - Relapsing Remmitting
Healthy Controls
cAMP Levels
4 hours
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS - Secondary Progressive | 72.6 pmol cAMP/mg protein | 56.8–90.1 | 16 |
| MS - Relapsing Remmitting | 79.1 pmol cAMP/mg protein | 59.9–108.2 | 19 |
| Healthy Controls | 103.5 pmol cAMP/mg protein | 63–149.6 | 19 |
MS - Secondary Progressive
MS - Relapsing Remmitting
Healthy Controls
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| MS - Secondary Progressive | 21 | 0 (0.0%) | |
| MS - Relapsing Remmitting | 24 | 0 (0.0%) | |
| Healthy Controls | 24 | 1 (4.2%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Lipoic Acid Levels
1 hour
How the body handles the medicineLipoic Acid Levels
2 hours
How the body handles the medicineLipoic Acid Levels
3 hours
How the body handles the medicineLipoic Acid Levels
4 hours
How the body handles the medicineLipoic Acid Levels
24 hour
How the body handles the medicineLipoic Acid Levels
48 hour
How the body handles the medicinecAMP Levels
2 hours
cAMP Levels
4 hours
Other measures (2)
RANTES Levels
24 hour
RANTES Levels
48 hour
Who could take part
MS (type not specified) · 18 and over
Inclusion/Exclusion criteria for MS subjects. Inclusion criteria: 1. Adult at least 18 years of age able to provide informed consent 2. Currently diagnosed with relapsing remitting or secondary progressive MS Exclusion criteria: 1. Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days 2. History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes 3. History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia) 4. MS exacerbation within 30 days of study entry 5. Systemically administered corticosteroids within 30 days of study entry 6. Pregnant or breast-feeding 7. Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study 8. 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 9. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study 10. Anemia as indicated by a POC hemoglobin \<12 11. 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: 1. Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days 2. History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes 3. History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia) 4. Pregnant or breast-feeding 5. Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study 6. 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 7. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study 8. Anemia as indicated by a POC hemoglobin \<12 9. 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Lipoic Acid Stimulates cAMP Production in Healthy Control and Secondary Progressive MS Subjects.Mol Neurobiol · 2018
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History
Started
Aug 2010
Main results due
Dec 2013
Finished
Dec 2013
Results posted
Jan 2017
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