VANCOUVER, British Columbia — The oral antioxidant lipoic acid has been proposed as a therapeutic approach in multiple sclerosis (MS), and studies have linked lipoic acid to decreased inflammation, as well as decreased optic nerve and spinal cord atrophy in the mouse model.
Building on this research, Rebecca Spain, MD, MSPH, from the VA Portland Healthcare System and Oregon Health and Science University, and colleagues assessed the effect of lipoic acid in patients with secondary-progressive multiple sclerosis. Results from their study were reported at the 2016 annual meeting of the American Academy of Neurology (AAN).
A total of 54 patients were randomly assigned to receive either lipoic acid 1200 mg/d or placebo over a 2-year period; 51 patients took at least 1 dose of the study drug and were included in the analysis. The treatment group comprised mostly women (61%), with an average age of 58.5 years (range, 40 to 69) and an average disease duration of 29.6 years (range, 9 to 51). Median expanded disability status scale score (EDSS) was 6.0 (range, 3.0 to 9.0), with 14.8% of the treatment group having an EDSS score greater than 6.5.
The primary end point of the study was reduction in whole brain atrophy as determined by percentage of brain volume change on magnetic resonance imaging (MRI). Secondary end points included atrophy of brain substructures; spinal cord atrophy; retinal and macular atrophy; and changes in neurologic examination, walking, cognition, fatigue, and quality of life.
A total of 4 (7.8%) subjects withdrew from the study due to glomerulonephritis, testicular cancer, renal failure, and intolerance of the MRI procedure . The most common adverse events reported included injuries, infections, and gastrointestinal disorders.
Adherence to treatment was greater than 90% in 93% of participants (>80% for all participants), as assessed by pill count. Mean baseline CMax was 3.04 ± 0.43 ng/mL (range, 0.69 to 8.47), with no significant difference identified at month 12.
A significant reduction in brain atrophy was noted (P<.004), with a trend toward increased walking speed and a decrease in the number of falls.
Although larger trials are warranted to confirm the results of this analysis, the investigators report a neuroprotective effect with lipoic acid, as well as an overall favorable safety and tolerability profile.
Spain RI, Powers K, Murchison C, et al. Lipoic acid for neuroprotection in secondary progressive multiple sclerosis: results of a randomized controlled pilot trial. Presented at: The 68th Annual Meeting of the American Academy of Neurology; April 15-21, 2016; Vancouver, British Columbia, Canada. Poster P1.373.