CompletedPhase 1MS (type not specified)NCT00997438

What it found

Results posted, no main test reported

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

GroupValueIntervalNumber analysed
MS - Secondary Progressive1376.14 ng/mL359.41 (Standard Error)15
MS - Relapsing Remmitting1609.07 ng/mL312.47 (Standard Error)21
Healthy Controls1428.05 ng/mL330.02 (Standard Error)19

MS - Secondary Progressive

1376.14

MS - Relapsing Remmitting

1609.07

Healthy Controls

1428.05

Lipoic Acid Levels

2 hours

GroupValueIntervalNumber analysed
MS - Secondary Progressive1125.71 ng/mL291.4 (Standard Error)15
MS - Relapsing Remmitting1167.33 ng/mL205.02 (Standard Error)21
Healthy Controls1348 ng/mL205.91 (Standard Error)19

MS - Secondary Progressive

1125.71

MS - Relapsing Remmitting

1167.33

Healthy Controls

1348

Lipoic Acid Levels

3 hours

GroupValueIntervalNumber analysed
MS - Secondary Progressive667.86 ng/mL138.24 (Standard Error)15
MS - Relapsing Remmitting638.4 ng/mL114.41 (Standard Error)21
Healthy Controls793.89 ng/mL173.39 (Standard Error)19

MS - Secondary Progressive

667.86

MS - Relapsing Remmitting

638.4

Healthy Controls

793.89

Lipoic Acid Levels

4 hours

GroupValueIntervalNumber analysed
MS - Secondary Progressive268.6 ng/mL73.15 (Standard Error)15
MS - Relapsing Remmitting252.75 ng/mL33.85 (Standard Error)21
Healthy Controls394.1 ng/mL129.15 (Standard Error)19

MS - Secondary Progressive

268.6

MS - Relapsing Remmitting

252.75

Healthy Controls

394.1

Lipoic Acid Levels

24 hour

GroupValueIntervalNumber analysed
MS - Secondary Progressive0.78 ng/mL0.13 (Standard Error)15
MS - Relapsing Remmitting0.87 ng/mL0.05 (Standard Error)21
Healthy Controls0.78 ng/mL0.06 (Standard Error)19

MS - Secondary Progressive

0.78

MS - Relapsing Remmitting

0.87

Healthy Controls

0.78

Lipoic Acid Levels

48 hour

GroupValueIntervalNumber analysed
MS - Secondary Progressive0.55 ng/mL0.15 (Standard Error)15
MS - Relapsing Remmitting0.7 ng/mL0.05 (Standard Error)21
Healthy Controls0.57 ng/mL0.04 (Standard Error)19

MS - Secondary Progressive

0.55

MS - Relapsing Remmitting

0.7

Healthy Controls

0.57

cAMP Levels

2 hours

GroupValueIntervalNumber analysed
MS - Secondary Progressive75.9 pmol cAMP/mg protein46–101.516
MS - Relapsing Remmitting75.8 pmol cAMP/mg protein56.8–11319
Healthy Controls96.6 pmol cAMP/mg protein75.1–129.219

MS - Secondary Progressive

75.9

MS - Relapsing Remmitting

75.8

Healthy Controls

96.6

cAMP Levels

4 hours

GroupValueIntervalNumber analysed
MS - Secondary Progressive72.6 pmol cAMP/mg protein56.8–90.116
MS - Relapsing Remmitting79.1 pmol cAMP/mg protein59.9–108.219
Healthy Controls103.5 pmol cAMP/mg protein63–149.619

MS - Secondary Progressive

72.6

MS - Relapsing Remmitting

79.1

Healthy Controls

103.5

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
MS - Secondary Progressive210 (0.0%)
MS - Relapsing Remmitting240 (0.0%)
Healthy Controls241 (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 medicine
  • Lipoic Acid Levels

    2 hours

    How the body handles the medicine
  • Lipoic Acid Levels

    3 hours

    How the body handles the medicine
  • Lipoic Acid Levels

    4 hours

    How the body handles the medicine
  • Lipoic Acid Levels

    24 hour

    How the body handles the medicine
  • Lipoic Acid Levels

    48 hour

    How the body handles the medicine
  • cAMP 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

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Related trials

History

    1. Started

      Aug 2010

    2. Main results due

      Dec 2013

    3. Finished

      Dec 2013

    4. Results posted

      Jan 2017

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