Multiple SclerosisPhase 2LAPMSNCT03161028
Lipoic Acid for Progressive Multiple Sclerosis (MS)
A Phase 2 study testing Lipoic acid in people with Multiple Sclerosis, run by VA Office of Research and Development at 11 sites in 2 countries.
Trial summary
The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- 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?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 17 Aug 2018to 30 Jun 2024
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of progressive MS as defined by the study
- Able to give informed consent and to adhere to study procedures.
- Expanded Disability Status Scale (EDSS) 3.0 - 6.5: ambulatory for at least 20 meters without rest and use of bilateral aids (canes, crutches, walker) or better.
Who cannot join
- A self-reported medical or neurological problem other than MS that is a cause of progressive or fluctuating gait dysfunction
- Unable to undergo MRI
- Unable to follow directions in English as standardized scales are not all validated in other languages.
- Current major disease or disorder other than MS (e.g., cancer, renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, etc.) that may interfere with study procedures. Note: Stable abnormal laboratory values of no more than Grade 1 determined to not be of clinical significance to the primary treating physician for that condition may be permitted per local site investigator discretion.
- Pregnant or breast-feeding.
- Insulin-dependent diabetes or diabetes not controlled on oral diabetes medications.
Show all 10Show fewer
- Scheduled (every 3 months or more frequently) IV or oral steroids in the year prior to enrolment.
- IV or oral steroids in the 60 days prior to enrolment.
- Use of LA in the prior 2 years exceeding the equivalent of 1200mg daily for 3 months.
- Participation in the pilot LA in SPMS trial.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
University of Colorado
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Vermont
Burlington, Vermont, 05401
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
University of Utah
Salt Lake City, Utah, 84148
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
Swedish Medical Center
Seattle, Washington, 98122
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422
About this study
Official title: Lipoic Acid for the Treatment of Progressive Multiple Sclerosis
The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis.
Read the detailed description
This two-year study will determine if daily oral intake of lipoic acid will prove superior to placebo in reducing injury to the brain and maintaining mobility in progressive MS. Mobility will be assessed with the timed 25-foot walk test and 2-minute timed walk test as well as fall counts. Neuroprotection will be measured by the extent of brain volume loss seen on MRI.
- Conditions
- Multiple Sclerosis
- Being tested
- Lipoic acid, Placebo
- Keywords
- multiple sclerosis, magnetic resonance imaging, gait, neuroprotective agents, thioctic acid, alpha-lipoic acid, mobility, chronic progressive multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
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 for two years 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 for two years 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 | 59 subjects receive oral lipoic acid 1200mg daily Receives: Drug: Lipoic acid |
| Arm 2: Placebo | Placebo comparator | 59 subjects receive placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mobility: Timed 25 Foot Walk
T25FW was transformed to walking speed by dividing 25 feet by the completion time in seconds (ft/sec). The change in walking speed across 24 months was compared between treatment groups using a mixed models analysis.
Measured: 24 months
Secondary outcomes (3)
Change in Mobility: 2-minute Timed Walk
The score is the distance, in meters, the subject walks in 2 minutes. The change in walking distance across 24 months was compared between treatment groups using a mixed models analysis.
Measured: 24 months
Mobility: Fall Count
Change in number of falls recorded from Baseline to year 2
Measured: 24 months
Brain Atrophy by MRI
Change in whole brain volume from baseline to 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start17 Aug 2018
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
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 SclerosisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rebecca I. Spain, MD MSPH, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161028
- Sponsor's protocol ID
- B2682-R
- Acronym
- LAPMS
- Status last verified
- Feb 2025
- First submitted
- 18 May 2017
- Last updated
- 3 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spain RI, Paz Soldan MM, Freedman MS, Repovic P, Solomon AJ, Rinker JR, Wallin MT, Haselkorn JK, Stuve O, Gross RH, Waslo CS, Hildebrand A, Morris CD, Mitchell J, Turner AP, Schwartz DL, Metz J, Rooney W. Lipoic Acid for Treatment of Progressive Multiple Sclerosis: A Phase 2 Randomized Clinical Trial. Neurology. 2026 Jan 13;106(1):e214454. doi: 10.1212/WNL.0000000000214454. Epub 2025 Dec 15.
PubMed 41397213Spain RI, Hildebrand A, Waslo CS, Rooney WD, Emmons J, Schwartz DL, Freedman MS, Paz Soldan MM, Repovic P, Solomon AJ, Rinker J 2nd, Wallin M, Haselkorn JK, Stuve O, Gross RH, Turner AP. Processing speed and memory test performance are associated with different brain region volumes in Veterans and others with progressive multiple sclerosis. Front Neurol. 2023 Jun 8;14:1188124. doi: 10.3389/fneur.2023.1188124. eCollection 2023.
PubMed 37360346
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipoic Acid for the Treatment of Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03161028
- Acronym / sponsor ID
- LAPMS / B2682-R
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, magnetic resonance imaging, gait, neuroprotective agents, thioctic acid, alpha-lipoic acid, mobility, chronic progressive multiple sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Posted 3 Mar 2025
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 preserve mobility and protect the brain in progressive forms of multiple sclerosis.
Detailed description
This two-year study will determine if daily oral intake of lipoic acid will prove superior to placebo in reducing injury to the brain and maintaining mobility in progressive MS. Mobility will be assessed with the timed 25-foot walk test and 2-minute timed walk test as well as fall counts. Neuroprotection will be measured by the extent of brain volume loss seen on MRI.
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 acid59 subjects receive oral lipoic acid 1200mg daily |
| Arm 2: Placebo | Placebo comparator | Drug: Placebo59 subjects receive placebo daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of progressive MS as defined by the study
- Able to give informed consent and to adhere to study procedures.
- Expanded Disability Status Scale (EDSS) 3.0 - 6.5: ambulatory for at least 20 meters without rest and use of bilateral aids (canes, crutches, walker) or better.
Key exclusion criteria (10 listed)
- A self-reported medical or neurological problem other than MS that is a cause of progressive or fluctuating gait dysfunction
- Unable to undergo MRI
- Unable to follow directions in English as standardized scales are not all validated in other languages.
- Current major disease or disorder other than MS (e.g., cancer, renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, etc.) that may interfere with study procedures. Note: Stable abnormal laboratory values of no more than Grade 1 determined to not be of clinical significance to the primary treating physician for that condition may be permitted per local site investigator discretion.
- Pregnant or breast-feeding.
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 for two years 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 for two years starting on day one of the study and ending on the last day of study participation | Drug | Arm 2: Placebo |
Primary outcome
Change in Mobility: Timed 25 Foot Walk
Time frame: 24 months
T25FW was transformed to walking speed by dividing 25 feet by the completion time in seconds (ft/sec). The change in walking speed across 24 months was compared between treatment groups using a mixed models analysis.
3 secondary outcomes
Change in Mobility: 2-minute Timed Walk
Time frame: 24 months
Mobility: Fall Count
Time frame: 24 months
Brain Atrophy by MRI
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41397213Spain RI, Paz Soldan MM, Freedman MS, Repovic P, Solomon AJ, Rinker JR, Wallin MT, Haselkorn JK, Stuve O, Gross RH, Waslo CS, Hildebrand A, Morris CD, Mitchell J, Turner AP, Schwartz DL, Metz J, Rooney W. Lipoic Acid for Treatment of Progressive Multiple Sclerosis: A Phase 2 Randomized Clinical Trial. Neurology. 2026 Jan 13;106(1):e214454. doi: 10.1212/WNL.0000000000214454. Epub 2025 Dec 15.
- Derived from this study: PubMed 37360346Spain RI, Hildebrand A, Waslo CS, Rooney WD, Emmons J, Schwartz DL, Freedman MS, Paz Soldan MM, Repovic P, Solomon AJ, Rinker J 2nd, Wallin M, Haselkorn JK, Stuve O, Gross RH, Turner AP. Processing speed and memory test performance are associated with different brain region volumes in Veterans and others with progressive multiple sclerosis. Front Neurol. 2023 Jun 8;14:1188124. doi: 10.3389/fneur.2023.1188124. eCollection 2023.
- Individual participant dataSharing planned: No
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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 I. Spain, MD MSPH principal investigator
VA Portland Health Care System, Portland, OR
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lipoic acid in people with Multiple Sclerosis, run by VA Office of Research and Development at 11 sites in 2 countries.
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 10 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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. 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 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.
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 3 Mar 2025). 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?
Change in Mobility: Timed 25 Foot Walk (time frame: 24 months). 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 NCT03161028, 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 3 Mar 2025; AzTrials last refreshed its copy on 28 Oct 2026.