Lipoic Acid for Progressive Multiple Sclerosis (MS)

Completed · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT03161028

Run by

VA Office of Research and Development

People needed

115

Starts

2018-08-17

Expected to finish

2024-06-30

Last updated by the study team

2025-03-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Colorado — Aurora, Colorado, United States
• Washington DC VA Medical Center, Washington, DC — Washington D.C., District of Columbia, United States
• VA Portland Health Care System, Portland, OR — Portland, Oregon, United States
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States
• University of Vermont — Burlington, Vermont, United States
• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States
• Swedish Medical Center — Seattle, Washington, United States
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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