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History of Changes for Study: NCT00997438
Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Latest version (submitted November 30, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 16, 2009 None (earliest Version on record)
2 June 24, 2010 Study Status, Eligibility and Study Description
3 June 25, 2010 Outcome Measures and Study Status
4 August 3, 2010 Study Status, Arms and Interventions, Eligibility and Study Description
5 January 24, 2012 Recruitment Status, Sponsor/Collaborators, Study Status and Contacts/Locations
6 November 30, 2016 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations, Arms and Interventions, Study Design, Study Description, Study Identification and Results
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Study NCT00997438
Submitted Date:  October 16, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: 5659
Brief Title: Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Official Title: Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Secondary IDs: OHSU eIRB#5659
Open or close this module Study Status
Record Verification: October 2009
Overall Status: Not yet recruiting
Study Start: October 2009
Primary Completion: June 2012 [Anticipated]
Study Completion: December 2012 [Anticipated]
First Submitted: October 16, 2009
First Submitted that
Met QC Criteria:
October 16, 2009
First Posted: October 19, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 16, 2009
Last Update Posted: October 19, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Portland VA Medical Center
Responsible Party:
Collaborators: Oregon Health and Science University
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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 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.

Subjects will be recruited through patients of investigators at Portland VA Medical Center (PVAMC), Oregon Health & Science University (OHSU), and the community using flyers and word of mouth.

The following will occur during screening:

  • Medical history
  • Substance abuse assessment
  • Physical exam
  • Neurological exam
  • Weight
  • Urine pregnancy test, if applicable
  • Anemia testing

The rest of the study involves

  • Blood draws before lipoic acid is given, 1 hour, 2 hours, 3 hours, 4 hours, 24 and 48 hours after LA is given (3 ½ tablespoons)
  • Subjects will receive breakfast before they take LA
  • Subjects will take 4 - 300 mg capsules of lipoic acid (LA) for a total of 1200mg with about 1 cup of water
Detailed Description:
Open or close this module Conditions
Conditions: Multiple Sclerosis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: MS - secondary progressive
1200 mg of Lipoic acid supplement
Dietary Supplement: Lipoic Acid
300 mg Lipoic acid tablets from Vital Nutrients
Experimental: MS - relapsing remmitting
1200mg of Lipoic acid supplement
Dietary Supplement: Lipoic Acid
300 mg Lipoic acid tablets from Vital Nutrients
Experimental: Health controls
1200 mg of Lipoic acid supplement
Dietary Supplement: Lipoic Acid
300 mg Lipoic acid tablets from Vital Nutrients
Open or close this module Outcome Measures
Primary Outcome Measures:
1. cAMP and lipoic acid levels
[ Time Frame: 24 hour and 48 hour ]

Secondary Outcome Measures:
1. cytokine and chemokine levels
[ Time Frame: 24 hour and 48 hour ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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. Meets DSM-IV criteria for current substance abuse or dependence and has been sober 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. No clinically significant MS exacerbation within 30 days of the screening
  5. No systemically administered corticosteroids within 30 days of study entry
  6. Pregnant or breast-feeding
  7. Anti coagulant use such as heparin or coumadin or aspirin during the study
  8. Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk adverse events
  9. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
  10. Anemia

Inclusion/ Exclusion criteria for healthy controls.

Inclusion criteria:

1) Adult at least 18 years of age able to provide informed consent

Exclusion criteria:

  1. Meets DSM-IV criteria for current substance abuse or dependence and has been sober 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 or coumadin or aspirin during the study
  6. Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase 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
Open or close this module Contacts/Locations
Central Contact Person: Daniel Carr, Ph.D.
Telephone: 503-721-7918
Email: carrd@ohsu.edu
Central Contact Backup: Sonemany Salinthone, Ph.D.
Telephone: 095-56612
Email: salintho@ohsu.edu
Study Officials: Daniel Carr, Ph.D
Principal Investigator
Portland VA Medical Center and Oregon Health & Science University
Locations: United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Contact:Contact: Daniel Carr, Ph.D 503-721-7918 carrd@ohsu.edu
Portland VA Medical Center
Portland, Oregon, United States, 97239
Contact:Contact: Sonemany Salinthone, Ph.D salintho@ohsu.edu
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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