A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT00676156 |
Recruitment Status
:
Completed
First Posted
: May 12, 2008
Last Update Posted
: November 6, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | May 7, 2008 | |||
First Posted Date ICMJE | May 12, 2008 | |||
Last Update Posted Date | November 6, 2012 | |||
Study Start Date ICMJE | December 2005 | |||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
To determine the pharmacokinetics of orally administered LA 1200 mg. This will assess the variability in bioavailability of LA and the feasibility of conducting a more focused PK assessment in future studies with LA. [ Time Frame: November 2008 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00676156 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
To study salivary LA concentrations corresponding to the serum levels. [ Time Frame: November 2008 ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis | |||
Official Title ICMJE | A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis | |||
Brief Summary | The purpose of this study is to learn about an investigational drug known as oral lipoic acid (LA) that may help treat multiple sclerosis. This study will measure how a person's body absorbs and breaks down the drug (pharmacokinetics) and will compare four different forms of the drug from four different manufacturers as well as LA in conjunction with fish oil. | |||
Detailed Description | Multiple sclerosis (MS) is a common, often disabling inflammatory disease of the central nervous system (CNS). Present treatments for MS are only partially effective, available only in injectable forms, have significant side effects and are very costly. Developing more effective and better-tolerated treatments of MS thus remains an important goal for the improvement of the care of MS. Lipoic acid (LA) is an antioxidant that is widely available as a dietary supplement. The primary outcome of this study is to determine the pharmacokinetics of oral LA 1200 mg to see if we can identify factors affecting the bioavailability of LA. We will also study the salivary concentrations of oral LA and its correlation with the serum LA concentrations. We will also study the effects of LA on the immunological markers after four hours of administration. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Multiple Sclerosis | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
40 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | November 2008 | |||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00676156 | |||
Other Study ID Numbers ICMJE | OHSU IRB00001305 NCCAM 1K23 AT003258-01 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Vijayshree Yadav, Oregon Health and Science University | |||
Study Sponsor ICMJE | Oregon Health and Science University | |||
Collaborators ICMJE | National Center for Complementary and Integrative Health (NCCIH) | |||
Investigators ICMJE |
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PRS Account | Oregon Health and Science University | |||
Verification Date | November 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |