Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00997438
• Date of registration: 16/10/2009
• Prospective Registration: Yes
• Primary sponsor: Portland VA Medical Center
• Public title: Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
• Scientific title: Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
• Date of first enrolment: August 2010
• Target sample size: 69
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00997438
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Daniel Carr, Ph.D
• Affiliation: Portland VA Medical Center and Oregon Health & Science University

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Dietary Supplement: Lipoic Acid

Primary Outcome(s)

cAMP Levels [Time Frame: 4 hours]

Lipoic Acid Levels [Time Frame: 3 hours]

Lipoic Acid Levels [Time Frame: 48 hour]

Lipoic Acid Levels [Time Frame: 24 hour]

Lipoic Acid Levels [Time Frame: 4 hours]

cAMP Levels [Time Frame: 2 hours]

Lipoic Acid Levels [Time Frame: 1 hour]

Lipoic Acid Levels [Time Frame: 2 hours]

Secondary Outcome(s)

RANTES Levels [Time Frame: 48 hour]

RANTES Levels [Time Frame: 24 hour]

Secondary ID(s)

5659

OHSU eIRB#5659

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oregon Health and Science University

Results

• Results available: Yes
• Date Posted: 26/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00997438