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Antioxidant

Lipoic Acid for Progressive Multiple Sclerosis (LAPMS Trial)

Phase 2
Waitlist Available
Led By Rebecca I. Spain, MD MSPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of progressive MS as defined by the study
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in timed 25 foot walk from baseline to year 2
Awards & highlights

LAPMS Trial Summary

This trial will test if lipoic acid can help MS patients by preserving mobility and protecting the brain.

Who is the study for?
This trial is for people with progressive forms of multiple sclerosis who can walk at least 20 meters without rest, even if they need walking aids. They must be able to consent and follow the study's procedures in English. It's not for those with other major diseases, pregnant or breastfeeding individuals, insulin-dependent diabetics, recent steroid users, or participants in a prior lipoic acid trial.Check my eligibility
What is being tested?
The study aims to see if lipoic acid helps maintain mobility and brain health in progressive MS patients compared to a placebo. Participants will randomly receive either lipoic acid or an inactive substance (placebo) to assess the effectiveness of the treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, generally supplements like lipoic acid could cause skin rashes, stomach issues, changes in blood sugar levels among others. Placebos typically have no active ingredients but can still lead to perceived side effects.

LAPMS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My MS is getting worse as defined by the study.
Select...
I can walk at least 20 meters without resting, with or without walking aids.

LAPMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in timed 25 foot walk from baseline to year 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in timed 25 foot walk from baseline to year 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mobility: Timed 25 Foot Walk
Secondary outcome measures
Brain Atrophy by MRI
Mobility: 2-minute timed walk
Mobility: Fall count
Other outcome measures
Safety: laboratory safety monitoring, adverse event monitoring

LAPMS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1: Lipoic AcidExperimental Treatment1 Intervention
59 subjects receive oral lipoic acid 1200mg daily
Group II: Arm 2: PlaceboPlacebo Group1 Intervention
59 subjects receive placebo daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lipoic acid
2010
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,488 Total Patients Enrolled
15 Trials studying Multiple Sclerosis
1,083 Patients Enrolled for Multiple Sclerosis
Rebecca I. Spain, MD MSPHPrincipal InvestigatorVA Portland Health Care System, Portland, OR

Media Library

Lipoic acid (Antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT03161028 — Phase 2
Multiple Sclerosis Research Study Groups: Arm 1: Lipoic Acid, Arm 2: Placebo
Multiple Sclerosis Clinical Trial 2023: Lipoic acid Highlights & Side Effects. Trial Name: NCT03161028 — Phase 2
Lipoic acid (Antioxidant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03161028 — Phase 2
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT03161028 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for individuals to sign up and participate in this research?

"The pertinent information on clinicaltrials.gov signals that this trial isn't presently searching for participants, despite having initially been posted back in July 2018 and edited as recently as February 2022. Nevertheless, 557 other medical studies are recruiting patients at the moment."

Answered by AI

How many individuals are actively engaged in this clinical investigation?

"This clinical trial has stopped searching for suitable candidates. The study first appeared on July 1st 2018 and was most recently updated February 25th 2022. For those seeking other medical studies, there are 549 trials actively recruiting patients with multiple sclerosis and 8 trials using lipoic acid as a therapy that require volunteers."

Answered by AI

Is the age restriction for this clinical research limited to those below 60 years of age?

"The eligibility criteria for this medical trial stipulates that all participants must be at least 18 years old and no older than 70."

Answered by AI

Could I be a potential participant in this experiment?

"For consideration, prospective participants must have multiple sclerosis and be between 18-70 years old. Enrollment is currently open to around 115 individuals."

Answered by AI

What diseases or disorders can Lipoic acid be utilized to alleviate?

"Lipoic acid has been suggested as a potential therapeutic agent for diabetic neuralgia, with possible beneficial effects of nutritional supplementation and dietary or nutrition-based strategies."

Answered by AI

To what extent has this research been administered in medical centers?

"At this time, 9 medical centres are recruiting patients for the trial. These sites span across multiple cities including Birmingham, Aurora and Portland as well as other nearby areas. To reduce transportation costs it is beneficial to select a clinical site that is localised to you."

Answered by AI

Has the Federal Drug Administration (FDA) sanctioned Lipoic acid for consumer use?

"Based on the current evidence, our team at Power rated Lipoic acid's safety as a 2; there is some data available to suggest its security but no clinical trials proving efficacy yet."

Answered by AI

Has Lipoic acid been previously explored in scientific research?

"The first exploration into the efficacy of lipoic acid was conducted in 2008 at George E. Wahlen VA Medical Center and since then, 18356 trials have been concluded. Currently 8 studies are underway, primarily out of Birmingham, Alabama."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Washington DC VA Medical Center, Washington, DC
VA Portland Health Care System, Portland, OR
University of Utah
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
Utah
Mississippi
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

Honestly, curiosity and money. EDSS 6.0 gait with cane. Foot drop. PPMS.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Ottawa Hospital Research Institute: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Lipoic Acid for Progressive Multiple Sclerosis (MS)
2018. "Lipoic Acid for Progressive Multiple Sclerosis (MS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03161028.
All > Amyotrophic Lateral Sclerosis > Multiple Sclerosis
~17 spots leftby Apr 2025
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