A randomized controlled phase II trial of riluzole in early multiple sclerosis. (14th April 2014)

• Record Type: Journal Article
• Authors: Waubant, Emmanuelle; Maghzi, Amir‐Hadi; Revirajan, Nisha; Spain, Rebecca; Julian, Laura; Mowry, Ellen M.; Marcus, Jacqueline; Liu, Shuang; Jin, Chengshi; Green, Ari; McCulloch, Charles E.; Pelletier, Daniel
• Is Part Of: Annals of clinical and translational neurology. Volume 1:Number 5(2014:May)
• Page Start: 340
• Page End: 347
• Publication Date: 2014-04-14
• Subjects: Nervous system -- Diseases -- Periodicals; Neurology -- Periodicals; 616.8005
• DOI: 10.1002/acn3.60
• Languages: English
• ISSNs: 2328-9503

Abstract

<abstract abstract-type="main" id="acn360-abs-0001"> <title>Abstract</title> <sec id="acn360-sec-0001" sec-type="section"> <title>Objectives</title> <p>We evaluated the effect of riluzole versus placebo added to weekly IM interferon beta‐1a in early multiple sclerosis (MS).</p> </sec> <sec id="acn360-sec-0002" sec-type="section"> <title>Methods</title> <p>This is a randomized (1:1), double‐blind, placebo‐controlled trial of riluzole 50 mg twice daily in subjects with MS onset less than 1 year prior. Trial participation was up to 3 years. The primary endpoint was change in percent brain volume change. Secondary endpoints included changes in normalized gray and normal‐appearing white matter volumes, retinal nerve fiber layer thickness (RNFL), MS Functional Composite and Symbol Digit Modalities Test scores. Mixed model regression analysis was used to compare the changes over time between groups.</p> </sec> <sec id="acn360-sec-0003" sec-type="section"> <title>Results</title> <p>Forty‐three subjects were randomized to study drug (22 riluzole, 21 placebo). Baseline characteristics were overall similar between groups except for older age (<italic>P</italic> = 0.042), higher normalized cerebrospinal fluid volume (<italic>P</italic> = 0.050), lower normalized gray matter volume (<italic>P</italic> = 0.14), and thinner RNFL (<italic>P</italic> = 0.043) in the riluzole group. In the primary analysis, percent brain volume change in the placebo group decreased at a rate of 0.49% per year whereas the riluzole group decreased by 0.86% per year (0.37% more per year; 95% CI −0.78, 0.024; <italic>P</italic> = 0.065). Although age did not influence the rate of brain volume decline, the difference between groups was attenuated after adjustment for baseline normalized gray matter and lesion volume (0.26% more per year in riluzole group; 95% CI −0.057, 0.014; <italic>P</italic> = 0.22). Analyses of secondary outcomes showed no differences between groups.</p> </sec> <sec id="acn360-sec-0004" sec-type="section"> <title>Interpretation</title> <p>This trial provides class 1 evidence that riluzole treatment does not meaningfully reduce brain atrophy progression in early MS.</p> </sec> </abstract>