Lipoic Acid for Progressive Multiple Sclerosis (MS) (LAPMS)

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    118
  • sponsor
    VA Office of Research and Development
Updated on 5 March 2022
chronic progressive multiple sclerosis

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.

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.

Details
Condition Multiple Sclerosis
Treatment Placebo, Lipoic acid
Clinical Study IdentifierNCT03161028
SponsorVA Office of Research and Development
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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