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A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F14%3A10218374" target="_blank" >RIV/00216208:11110/14:10218374 - isvavai.cz</a>

  • Result on the web

    <a href="http://dx.doi.org/10.1007/s00415-014-7264-4" target="_blank" >http://dx.doi.org/10.1007/s00415-014-7264-4</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1007/s00415-014-7264-4" target="_blank" >10.1007/s00415-014-7264-4</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

    A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis

  • Original language description

    The phase III placebo-controlled BRAVO study assessed laquinimod effects in patients with relapsing-remitting MS (RRMS), and descriptively compared laquinimod with interferon beta (IFN beta)-1a (Avonex(A (R)) reference arm). RRMS patients age 18-55 yearswith Expanded Disability Status Scale (EDSS) scores of 0-5.5 and documented pre-study relapse (a parts per thousand yen 1 in previous year, 2 in previous 2 years, or 1 in previous 1-2 years and a parts per thousand yen 1 GdE lesion in the previous year)were randomized (1:1:1) to laquinimod 0.6 mg once-daily, matching oral placebo, or IFN beta-1a IM 30 mu g once-weekly (rater-blinded design), for 24 months. The primary endpoint was annualized relapse rate (ARR); secondary endpoints included percent brain volume change (PBVC) and 3-month confirmed disability worsening. In all, 1,331 patients were randomized: laquinimod (n = 434), placebo (n = 450), and IFN beta-1a (n = 447). ARR was not significantly reduced with laquinimod [-18 %, risk

  • Czech name

  • Czech description

Classification

  • 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

Result continuities

  • Project

  • Continuities

    I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Others

  • Publication year

    2014

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    Journal of Neurology

  • ISSN

    0340-5354

  • e-ISSN

  • Volume of the periodical

    261

  • Issue of the periodical within the volume

    4

  • Country of publishing house

    DE - GERMANY

  • Number of pages

    11

  • Pages from-to

    773-783

  • UT code for WoS article

    000334177100018

  • EID of the result in the Scopus database