Multiple SclerosisPhase 1NCT00997438
Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
A Phase 1 study testing Lipoic Acid in people with Multiple Sclerosis, run by Portland VA Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Lipoic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Dec 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult at least 18 years of age able to provide informed consent
- Currently diagnosed with relapsing remitting or secondary progressive MS
- 1) Adult at least 18 years of age able to provide informed consent
Who cannot join
- Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days
- History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes
- History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia)
- MS exacerbation within 30 days of study entry
- Systemically administered corticosteroids within 30 days of study entry
- Pregnant or breast-feeding
Show all 20Show fewer
- Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study
- 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
- Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
- Anemia as indicated by a POC hemoglobin <12
- 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
- Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days
- History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes
- History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia)
- Pregnant or breast-feeding
- Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study
- 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
- Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
- Anemia as indicated by a POC hemoglobin <12
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Health & Science University
Portland, Oregon, 97239
Portland VA Medical Center
Portland, Oregon, 97239
About this study
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.
Read the detailed description
Subjects (healthy control, relapsing remitting MS and secondary progressive MS) 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 Questionnaire to include questions about drug and alcohol use
- Self Administered Expanded Disability Status Scale (EDSS) Questionnaire (MS participants only)
- Vital Signs (heart rate, respiratory rate, blood pressure) will be measured and recorded
- Physical Exam (MS participants only unless necessary, based on the Medical History Questionnaire or vital signs, to ensure participant safety)
- Neurological Exam (MS participants only unless necessary, based on the Medical History Questionnaire or vital signs, to ensure participant safety)
- Weight
- Urine pregnancy test, if applicable
- Anemia testing by finger stick (approximately 1 drop)
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
Blood will be processed to obtain plasma (from which lipoic acid concentrations will be measured) and PBMCs (from which cAMP and cytokines/chemokines will be measured).
- Conditions
- Multiple Sclerosis
- Being tested
- Lipoic Acid
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipoic AcidDietary supplement
300 mg Lipoic acid tablets from Vital Nutrients
| Study group | Role | What they receive |
|---|---|---|
| MS - Secondary Progressive | Experimental | 1200 mg of Lipoic acid supplement Receives: Dietary Supplement: Lipoic Acid |
| MS - Relapsing Remitting | Experimental | 1200mg of Lipoic acid supplement Receives: Dietary Supplement: Lipoic Acid |
| Healthy Controls | Experimental | 1200 mg of Lipoic acid supplement Receives: Dietary Supplement: Lipoic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipoic Acid Levels
Plasma concentration of LA
Measured: 1 hour
Lipoic Acid Levels
Plasma concentration of LA
Measured: 2 hours
Lipoic Acid Levels
Plasma concentration of LA
Measured: 3 hours
Lipoic Acid Levels
Plasma concentration of LA
Measured: 4 hours
Lipoic Acid Levels
Plasma concentration of LA
Measured: 24 hour
Lipoic Acid Levels
Plasma concentration of LA
Measured: 48 hour
cAMP Levels
Measured: 2 hours
cAMP Levels
Measured: 4 hours
Secondary outcomes (2)
RANTES Levels
Measured: 24 hour
RANTES Levels
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startAug 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portland VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Daniel Carr, Portland VA Medical Center
- Investigators
- Daniel Carr, Ph.D, Principal investigator, Portland VA Medical Center and Oregon Health & Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997438
- Sponsor's protocol ID
- 5659
- Other IDs
- OHSU eIRB#5659
- Status last verified
- Nov 2016
- First submitted
- 16 Oct 2009
- Last updated
- 26 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fiedler SE, Yadav V, Kerns AR, Tsang C, Markwardt S, Kim E, Spain R, Bourdette D, Salinthone S. Lipoic Acid Stimulates cAMP Production in Healthy Control and Secondary Progressive MS Subjects. Mol Neurobiol. 2018 Jul;55(7):6037-6049. doi: 10.1007/s12035-017-0813-y. Epub 2017 Nov 15.
PubMed 29143287
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00997438
- Acronym / sponsor ID
- 5659
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Portland VA Medical CenterUS federal agency
- Collaborators
- Oregon Health and Science University
- Study start
- Aug 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Posted 26 Jan 2017
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 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.
Detailed description
Subjects (healthy control, relapsing remitting MS and secondary progressive MS) 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 Questionnaire to include questions about drug and alcohol use
- Self Administered Expanded Disability Status Scale (EDSS) Questionnaire (MS participants only)
- Vital Signs (heart rate, respiratory rate, blood pressure) will be measured and recorded
- Physical Exam (MS participants only unless necessary, based on the Medical History Questionnaire or vital signs, to ensure participant safety)
- Neurological Exam (MS participants only unless necessary, based on the Medical History Questionnaire or vital signs, to ensure participant safety)
- Weight
- Urine pregnancy test, if applicable
- Anemia testing by finger stick (approximately 1 drop)
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
Blood will be processed to obtain plasma (from which lipoic acid concentrations will be measured) and PBMCs (from which cAMP and cytokines/chemokines will be measured).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MS - Secondary Progressive | Experimental | Dietary Supplement: Lipoic Acid1200 mg of Lipoic acid supplement |
| MS - Relapsing Remitting | Experimental | Dietary Supplement: Lipoic Acid1200mg of Lipoic acid supplement |
| Healthy Controls | Experimental | Dietary Supplement: Lipoic Acid1200 mg of Lipoic acid supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult at least 18 years of age able to provide informed consent
- Currently diagnosed with relapsing remitting or secondary progressive MS
- 1) Adult at least 18 years of age able to provide informed consent
Key exclusion criteria (20 listed)
- Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days
- History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes
- History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia)
- MS exacerbation within 30 days of study entry
- Systemically administered corticosteroids within 30 days of study entry
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 |
|---|---|---|
| Lipoic Acid300 mg Lipoic acid tablets from Vital Nutrients | Dietary supplement | Healthy Controls, MS - Relapsing Remitting, MS - Secondary Progressive |
Primary outcome
Lipoic Acid Levels
Time frame: 1 hour
Plasma concentration of LA
Lipoic Acid Levels
Time frame: 2 hours
Plasma concentration of LA
Lipoic Acid Levels
Time frame: 3 hours
Plasma concentration of LA
Lipoic Acid Levels
Time frame: 4 hours
Plasma concentration of LA
Lipoic Acid Levels
Time frame: 24 hour
Plasma concentration of LA
Lipoic Acid Levels
Time frame: 48 hour
Plasma concentration of LA
cAMP Levels
Time frame: 2 hours
cAMP Levels
Time frame: 4 hours
2 secondary outcomes
RANTES Levels
Time frame: 24 hour
RANTES Levels
Time frame: 48 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29143287Fiedler SE, Yadav V, Kerns AR, Tsang C, Markwardt S, Kim E, Spain R, Bourdette D, Salinthone S. Lipoic Acid Stimulates cAMP Production in Healthy Control and Secondary Progressive MS Subjects. Mol Neurobiol. 2018 Jul;55(7):6037-6049. doi: 10.1007/s12035-017-0813-y. Epub 2017 Nov 15.
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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.
Daniel Carr, Ph.D principal investigator
Portland VA Medical Center and Oregon Health & Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lipoic Acid in people with Multiple Sclerosis, run by Portland VA Medical Center at 2 sites 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 20 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 26 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lipoic Acid Levels (time frame: 1 hour). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00997438, which also lists 1 linked publication.
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 26 Jan 2017.