Multiple Sclerosis, Chronic ProgressivePhase 2/3NCT01188811
Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
A Phase 2/3 study testing lipoic acid in people with Multiple Sclerosis, Chronic Progressive, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Chronic Progressive
- What is being tested?
- lipoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2015
- Phase
- Phase 2/3
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of SPMS
- Age 40-70 years
- Able to understand English and able to give informed consent
Who cannot join
- Unable to undergo MRI testing
- For ambulatory subjects only, a self-reported medical or neurological condition other than MS that is a cause of progressive or fluctuating problems that affect walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis, uncontrolled heart or lung disease)
- For ambulatory subjects only, fixed and/or stable conditions of less than 1 years duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism, stroke, etc.)
- Pregnant or breast-feeding.
- Current major disease or disorder other than MS (such as cancer, kidney, heart or lung disease, post-traumatic stress disorder) that may interfere with study procedures
- Natalizumab, mitoxantrone, azathioprine taken in the last 12 months
Show all 11Show fewer
- Other immunosuppressants or chemotherapies taken in the last 12 months
- Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months
- IV or oral steroids taken in the past 60 days.
- Lipoic acid taken in the past 60 days.
- Subject has insulin-dependent diabetes or is not controlled on oral diabetes medications
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
Official title: Lipoic Acid for Neuroprotection in Secondary Progressive MS
The purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.
Read the detailed description
There are no approved medications that are neuroprotective or able to slow disability accumulation in secondary progressive multiple sclerosis (SPMS). This two-year study will determine if daily oral intake of lipoic acid, a natural supplement, will prove superior to placebo in reducing injury to the brain and reducing disability progression in SPMS. Neuroprotection will be measured by the extent of brain volume loss seen on MRI, and disability will be measured by neurological status and quality of life.
- Conditions
- Multiple Sclerosis, Chronic Progressive
- Being tested
- lipoic acid, Placebo
- Keywords
- Multiple Sclerosis, Multiple sclerosis, chronic progressive, Neuroprotective agents, Magnetic resonance imaging, Optical coherence tomography, Gait, Thioctic acid, Alpha-lipoic acid
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipoic acidDrug
Also called alpha lipoic acid
1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
PlaceboDrug
The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: lipoic acid | Experimental | 28 subjects receive oral lipoic acid 1200mg daily Receives: Drug: lipoic acid |
| Arm 2: placebo | Placebo comparator | 28 subjects receive placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Atrophy by MRI
Measured: % change brain volume from baseline to year 2
Secondary outcomes (2)
Disability Measures: Mobility
Measured: Change in Timed 25 Foot Walk from baseline to year 2
Safety Measure: Adverse Events
Measured: adverse events recorded from baseline to year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2015
- Study completionAug 2015
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 (2)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Chronic ProgressiveStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Rebecca Spain, MD MSPH, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188811
- Sponsor's protocol ID
- B7493-W
- Status last verified
- Dec 2016
- First submitted
- 25 Aug 2010
- Last updated
- 2 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Loy BD, Fling BW, Horak FB, Bourdette DN, Spain RI. Effects of lipoic acid on walking performance, gait, and balance in secondary progressive multiple sclerosis. Complement Ther Med. 2018 Dec;41:169-174. doi: 10.1016/j.ctim.2018.09.006. Epub 2018 Sep 22.
PubMed 30477834Spain R, Powers K, Murchison C, Heriza E, Winges K, Yadav V, Cameron M, Kim E, Horak F, Simon J, Bourdette D. Lipoic acid in secondary progressive MS: A randomized controlled pilot trial. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 28;4(5):e374. doi: 10.1212/NXI.0000000000000374. eCollection 2017 Sep.
PubMed 28680916
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipoic Acid for Neuroprotection in Secondary Progressive MS
- ClinicalTrials.gov ID
- NCT01188811
- Acronym / sponsor ID
- B7493-W
- Conditions
- Multiple Sclerosis, Chronic Progressive
- Keywords
- Multiple Sclerosis, Multiple sclerosis, chronic progressive, Neuroprotective agents, Magnetic resonance imaging, Optical coherence tomography, Gait, Thioctic acid, Alpha-lipoic acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Oregon Health and Science University
- Study start
- Oct 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Posted 2 Feb 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 the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.
Detailed description
There are no approved medications that are neuroprotective or able to slow disability accumulation in secondary progressive multiple sclerosis (SPMS). This two-year study will determine if daily oral intake of lipoic acid, a natural supplement, will prove superior to placebo in reducing injury to the brain and reducing disability progression in SPMS. Neuroprotection will be measured by the extent of brain volume loss seen on MRI, and disability will be measured by neurological status and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: lipoic acid | Experimental | Drug: lipoic acid28 subjects receive oral lipoic acid 1200mg daily |
| Arm 2: placebo | Placebo comparator | Drug: Placebo28 subjects receive placebo daily |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of SPMS
- Age 40-70 years
- Able to understand English and able to give informed consent
Key exclusion criteria (11 listed)
- Unable to undergo MRI testing
- For ambulatory subjects only, a self-reported medical or neurological condition other than MS that is a cause of progressive or fluctuating problems that affect walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis, uncontrolled heart or lung disease)
- For ambulatory subjects only, fixed and/or stable conditions of less than 1 years duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism, stroke, etc.)
- Pregnant or breast-feeding.
- Current major disease or disorder other than MS (such as cancer, kidney, heart or lung disease, post-traumatic stress disorder) that may interfere with study procedures
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 acidAlso: alpha lipoic acid1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation. | Drug | Arm 1: lipoic acid |
| PlaceboThe placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation | Drug | Arm 2: placebo |
Primary outcome
Brain Atrophy by MRI
Time frame: % change brain volume from baseline to year 2
2 secondary outcomes
Disability Measures: Mobility
Time frame: Change in Timed 25 Foot Walk from baseline to year 2
Safety Measure: Adverse Events
Time frame: adverse events recorded from baseline to year 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30477834Loy BD, Fling BW, Horak FB, Bourdette DN, Spain RI. Effects of lipoic acid on walking performance, gait, and balance in secondary progressive multiple sclerosis. Complement Ther Med. 2018 Dec;41:169-174. doi: 10.1016/j.ctim.2018.09.006. Epub 2018 Sep 22.
- Derived from this study: PubMed 28680916Spain R, Powers K, Murchison C, Heriza E, Winges K, Yadav V, Cameron M, Kim E, Horak F, Simon J, Bourdette D. Lipoic acid in secondary progressive MS: A randomized controlled pilot trial. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 28;4(5):e374. doi: 10.1212/NXI.0000000000000374. eCollection 2017 Sep.
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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.
Rebecca Spain, MD MSPH principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing lipoic acid in people with Multiple Sclerosis, Chronic Progressive, run by VA Office of Research and Development 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 11 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 2 Feb 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 2 Feb 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?
Brain Atrophy by MRI (time frame: % change brain volume from baseline to year 2). 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 NCT01188811, which also lists 2 linked publications.
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 2 Feb 2017.