A randomized controlled phase II trial of riluzole in early multiple sclerosis.

ABSTRACT:

Objectives

We evaluated the effect of riluzole versus placebo added to weekly IM interferon beta-1a in early multiple sclerosis (MS).

Methods

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.

Results

Forty-three subjects were randomized to study drug (22 riluzole, 21 placebo). Ba

SUBMITTER: Waubant E 

PROVIDER: S-EPMC4184685 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature