BACKGROUND: Two proof-of-concept clinical trials have provided evidence that laquinimod reduces disease activity in @entity1 with @entity3780 @entity15 . METHODS: We conducted a randomized, double-blind, phase 3 study at 139 sites in 24 countries. A total of 1106 @entity1 with @entity3780 @entity15 were randomly assigned in a 1:1 ratio to receive oral laquinimod at a dose of 0.6 mg once daily or placebo for 24 months. The primary end point was the annualized relapse rate during the 24-month period. Secondary end points included confirmed disability progression (defined as an increase in the score on the Expanded Disability Status Scale that was sustained for at least 3 months) and the cumulative number of @entity2287 -enhancing lesions and new or enlarging lesions on T(2)-weighted magnetic resonance imaging. RESULTS: Treatment with laquinimod as compared with placebo was associated with a modest reduction in the mean (  SE) annualized relapse rate (0.30  0.02 vs. 0.39  0.03, P=0.002) and with a reduction in the risk of confirmed disability progression (11.1% vs. 15.7%; hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.91; P=0.01). The mean cumulative numbers of @entity2287 -enhancing lesions and new or enlarging lesions on T(2)-weighted images were lower for @entity1 receiving laquinimod than for those receiving placebo (1.33  0.14 vs. 2.12  0.22 and 5.03  0.08 vs. 7.14  0.07, respectively; P<0.001 for both comparisons). Transient elevations in @entity493 aminotransferase levels to greater than three times the upper limit of the normal range were observed in 24 @entity1 receiving laquinimod (5%) and 8 receiving placebo (2%). CONCLUSIONS: In this phase 3 study, oral laquinimod administered once daily slowed the progression of disability and reduced the rate of relapse in @entity1 with @entity3780 @entity15 . (Funded by Teva Pharmaceutical Industries; ClinicalTrials.gov number, NCT00509145.).

Placebo-controlled trial of oral laquinimod for XXXX .

@entity1 :: ('9606', 'Species') :: ['patients'] @entity3780 :: ('MESH:D020529', 'Disease') :: ['relapsing-remitting'] @entity493 :: ('CHEBI:16449', 'Chemical') :: ['alanine'] @entity2287 :: ('MESH:D005682', 'Chemical') :: ['gadolinium'] @entity15 :: ('MESH:D009103', 'Disease') :: ['multiple sclerosis']
@entity15 :: (MESH:D009103,Disease) :: ['multiple sclerosis']
