Multiple SclerosisPhase 1NCT00676156
A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
A Phase 1 study testing oral lipoic acid (LA), lipoic acid (LA) with fish oil and LA without fish oil and R lipoic acid in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- oral lipoic acid (LA), lipoic acid (LA) with fish oil and LA without fish oil and R lipoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Nov 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite MS by McDonald's or Poser's criteria
- EDSS ≤ 7.5
- Age 18 to 80
Who cannot join
- No clinically significant MS exacerbation within 30 days of the screening
- No systemically administered corticosteroids within 30 days of study entry
- Patient not pregnant or breast feeding
- No LA in previous 2 weeks
- Not on anti-coagulants such as heparin, coumadin, or aspirin during study
- No other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events
- Inability to give informed consent
- Any condition which would make the patient, in the opinion of the investigator, unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University Multiple Sclerosis Dept.
Portland, Oregon, 97239
About this study
Official title: A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- oral lipoic acid (LA), lipoic acid (LA) with fish oil and LA without fish oil, R lipoic acid
- Keywords
- multiple sclerosis, lipoic acid, LA, pharmacokinetics, immunological effects
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral lipoic acid (LA)Drug
A single 1200 mg dose of oral LA will be administered.
lipoic acid (LA) with fish oil and LA without fish oilDrug
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.
R lipoic acidDrug
A single oral dose of 1200mg R enantiomer LA will be administered.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid. Receives: Drug: oral lipoic acid (LA) |
| B | Active comparator | This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design. Receives: Drug: lipoic acid (LA) with fish oil and LA without fish oil |
| C | Active comparator | This arm will include the study of a single dose of R enantiomer lipoic acid. Receives: Drug: R lipoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: November 2008
Secondary outcomes (1)
To study salivary LA concentrations corresponding to the serum levels.
Measured: November 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startDec 2005
- Primary completionFeb 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Vijayshree Yadav, Oregon Health and Science University
- Investigators
- Vijayshree Yadav, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676156
- Sponsor's protocol ID
- OHSU IRB00001305
- Other IDs
- NCCAM 1K23 AT003258-01
- Status last verified
- Nov 2012
- First submitted
- 7 May 2008
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00676156
- Acronym / sponsor ID
- OHSU IRB00001305
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, lipoic acid, LA, pharmacokinetics, immunological effects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Dec 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: oral lipoic acid (LA)This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid. |
| B | Active comparator | Drug: lipoic acid (LA) with fish oil and LA without fish oilThis arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design. |
| C | Active comparator | Drug: R lipoic acidThis arm will include the study of a single dose of R enantiomer lipoic acid. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Definite MS by McDonald's or Poser's criteria
- EDSS ≤ 7.5
- Age 18 to 80
Key exclusion criteria (8 listed)
- No clinically significant MS exacerbation within 30 days of the screening
- No systemically administered corticosteroids within 30 days of study entry
- Patient not pregnant or breast feeding
- No LA in previous 2 weeks
- Not on anti-coagulants such as heparin, coumadin, or aspirin during study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral lipoic acid (LA)A single 1200 mg dose of oral LA will be administered. | Drug | A |
| lipoic acid (LA) with fish oil and LA without fish oilSubjects 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. | Drug | B |
| R lipoic acidA single oral dose of 1200mg R enantiomer LA will be administered. | Drug | C |
Primary outcome
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
1 secondary outcome
To study salivary LA concentrations corresponding to the serum levels.
Time frame: November 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijayshree Yadav, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oral lipoic acid (LA), lipoic acid (LA) with fish oil and LA without fish oil and R lipoic acid in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2012.