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Completed

NCT Number: NCT03161028

Lipoic Acid for Progressive Multiple Sclerosis (MS)

The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lipoic acid

Drug

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.

Other names: Alpha-lipoic acid

Placebo

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Mobility: 2-minute Timed Walk

    Time frame: 24 months

    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.

  2. Mobility: Fall Count

    Time frame: 24 months

    Change in number of falls recorded from Baseline to year 2

  3. Brain Atrophy by MRI

    Time frame: 24 months

    Change in whole brain volume from baseline to 24 months

Other outcomes

  1. Safety: Adverse Event Monitoring

    Time frame: 24 months

    Participants with at least 1 treatment-emergent AE

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Lipoic Acid for the Treatment of Progressive Multiple Sclerosis

Acronym: LAPMS

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
May 19, 2017
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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