The study sites include: Birmingham, Alabama; Burlington, Vermont; Portland, Oregon; Salt Lake City, Utah; Seattle, Washington; Washington, D.C., and; Ontario, Canada.
Although results from studies testing the effect of lipoic acid (also known as alpha lipoic acid) on MS vary, some studies have shown immune-regulatory and anti-inflammatory effects of lipoic acid.
While its exact mechanism of action is unclear, studies suggest that lipoic acid blocks so-called free radicals (atoms, ions, or molecules with high chemical reactivity) derived from oxygen, called reactive oxygen species. These reactive oxygen species are normal byproducts of bodily processes. However, an excess of oxygen-derived free radicals can cause tissue injury or trigger immune cell reactions associated with MS.
The current clinical trial (NCT03161028) is based on results from a study, “Lipoic acid in secondary progressive MS: A randomized controlled pilot trial,” published in the journal Neurology Neuroimmunology & Neuroinflammation.
In the study, 51 participants (age range, 40-70) with secondary progressive MS received either daily oral 1,200 mg lipoic acid (27 participants) or placebo (24 participants) for two years. Results showed that participants treated with lipoic acid had a 68 percent reduction in brain tissue loss (brain atrophy, or shrinkage) compared with participants receiving placebo.
Now, the new clinical trial will assess the potential benefits and safety of lipoic acid treatment on 118 randomly assigned participants between 18 and 70 years of age, with primary or secondary progressive MS, who are able to walk with or without a walking aid.
Half of the participants will receive oral lipoic acid (1,200 mg), and the other half will receive placebo daily for two years.
At the trial’s seven sites, researchers will compare mobility functions between baseline (start of trial) and each subsequent visit.
The trial’s primary goal is a change in timed 25-foot walk from baseline, with or without walking aid, which is a measure of patients’ mobility and leg function performance. Secondary outcomes include changes in: the two-minute walk test, the recorded number of falls during the trial period, brain volume seen through magnetic resonance imaging (MRI), and treatment safety.
The National MS Society and the U.S. Department of Veterans Affairs are the main sponsors of the clinical trial. For contact details and more information about the study’s enrollment criteria and eligibility, readers may visit this link.