Placebo-controlled trial of oral laquinimod for multiple sclerosis

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F12%3A00103103" target="_blank" >RIV/00843989:_____/12:00103103 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1056/NEJMoa1104318" target="_blank" >http://dx.doi.org/10.1056/NEJMoa1104318</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1056/NEJMoa1104318" target="_blank" >10.1056/NEJMoa1104318</a>

Result language
angličtina
Original language name
Placebo-controlled trial of oral laquinimod for multiple sclerosis
Original language description
Two proof-of-concept clinical trials have provided evidence that laquinimod reduces disease activity in patients with relapsing-remitting multiple sclerosis. We conducted a randomized, double-blind, phase 3 study at 139 sites in 24 countries. A total of1106 patients with relapsing-remitting multiple sclerosis 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-monthperiod. 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 gadolinium-enhancing lesions and new or enlarging lesions on T-2-weighted magnetic resonance imaging. 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
Czech name
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Czech description
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Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FH - Neurology, neuro-surgery, nuero-sciences
OECD FORD branch
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Publication year
2012
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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