Lipoic acid in secondary progressive MS

Rebecca Spain, Katherine Powers, Charles Murchison, Elizabeth Heriza, Kimberly Winges, Vijayshree Yadav, Michelle Cameron, Ed Kim, Fay Horak, Jack Simon, Dennis Bourdette

Research output: Research - peer-reviewArticle

Abstract

To determine whether lipoic acid (LA), an endogenously produced antioxidant, slowed the whole-brain atrophy rate and was safe in secondary progressive MS (SPMS). Methods: Patients with SPMS aged 40-70 years enrolled in a single center, 2-year, double-blind, randomized trial of daily oral 1,200 mg LA vs placebo. Primary outcome was change in annualized percent change brain volume (PCBV). Secondary outcomes were changes in rates of atrophy of segmented brain, spinal cord, and retinal substructures, disability, quality of life, and safety. Intention-to-treat analysis used linear mixed models. Results: Participation occurred between May 2, 2011, and August 14, 2015. Study arms of LA (n = 27) and placebo (n = 24) were matched with mean age of 58.5 (SD 5.9) years, 61% women, mean disease duration of 29.6 (SD 9.5) years, and median Expanded Disability Status Score of 6.0 (interquartile range 1.75). After 2 years, the annualized PCBV was significantly less in the LA arm compared with placebo (-0.21 [standard error of the coefficient estimate (SEE) 0.14] vs -0.65 [SEE 0.10], 95% confidence interval [CI] 0.157-0.727, p = 0.002). Improved Timed 25-Foot Walk was almost but not significantly better in the LA than in the control group (-0.535 [SEE 0.358] vs 0.137 [SEE 0.247], 95% CI -1.37 to 0.03, p = 0.06). Significantly more gastrointestinal upset and fewer falls occurred in LA patients. Unexpected renal failure (n = 1) and glomerulonephritis (n = 1) occurred in the LA cohort. Compliance, measured by pill counts, was 87%. Conclusions: LA demonstrated a 68% reduction in annualized PCBV and suggested a clinical benefit in SPMS while maintaining favorable safety, tolerability, and compliance over 2 years. ClinicalTrials.gov identifier: NCT01188811. Classification of evidence: This study provides Class I evidence that for patients with SPMS, LA reduces the rate of brain atrophy.

LanguageEnglish (US)
Article number374
JournalNeurology: Neuroimmunology and NeuroInflammation
Volume4
Issue number5
DOIs
StatePublished - 2017
Externally publishedYes

Fingerprint

Thioctic Acid
Brain
Atrophy
Placebos
Compliance
Confidence Intervals
Safety
Intention to Treat Analysis
Glomerulonephritis
Renal Insufficiency
Linear Models
Spinal Cord
Antioxidants
Quality of Life
Control Groups

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Lipoic acid in secondary progressive MS. / Spain, Rebecca; Powers, Katherine; Murchison, Charles; Heriza, Elizabeth; Winges, Kimberly; Yadav, Vijayshree; Cameron, Michelle; Kim, Ed; Horak, Fay; Simon, Jack; Bourdette, Dennis.

In: Neurology: Neuroimmunology and NeuroInflammation, Vol. 4, No. 5, 374, 2017.

Research output: Research - peer-reviewArticle

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AU - Cameron,Michelle

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AU - Simon,Jack

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