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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in timed 25 foot walk from baseline to year 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in timed 25 foot walk from baseline to year 2
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
1,620 Previous Clinical Trials
3,323,291 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My MS is getting worse as defined by the study.I can walk at least 20 meters without resting, with or without walking aids.I can follow directions in English.I do not have any major illness other than MS that could affect the study.I have a health condition besides MS that affects my ability to walk.I have not taken IV or oral steroids in the last 60 days.I have used strong painkillers exceeding a certain dose for over 3 months in the past 2 years.I need insulin for my diabetes or my diabetes is not controlled by pills.I can walk at least 20 meters without resting, with or without walking aids.I have been on scheduled steroids, either IV or oral, in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Lipoic Acid
- Group 2: Arm 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT03161028 — Phase 2
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