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| ID | Type | Description | Link |
|---|---|---|---|
| NCCAM 1K23 AT003258-01 |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid. |
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| B | Active Comparator | This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design. |
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| C | Active Comparator | This arm will include the study of a single dose of R enantiomer lipoic acid. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral lipoic acid (LA) | Drug | A single 1200 mg dose of oral LA will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | November 2008 |
| Measure | Description | Time Frame |
|---|---|---|
| To study salivary LA concentrations corresponding to the serum levels. | November 2008 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vijayshree Yadav, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University Multiple Sclerosis Dept. | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| lipoic acid (LA) with fish oil and LA without fish oil |
| Drug |
Subjects will be randomized to receive either 1 dose of 1200 mg LA with fish oil and then will be crossed-over to receive 1 dose of 1200 LA without fish oil. There will be a 1-week wash out period between the cross over. |
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| R lipoic acid | Drug | A single oral dose of 1200mg R enantiomer LA will be administered. |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D009821 | Oils |