Placebo-Controlled Trial of Oral Laquinimod for Multiple Sclerosis

In this placebo-controlled, phase 3 trial involving patients with relapsing–remitting multiple sclerosis, oral laquinimod administered once daily reduced the number of clinical relapses and slowed disability progression. Laquinimod is an oral quinoline-3-carboxamide small molecule selected for its e...

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Veröffentlicht in:NEW ENGLAND JOURNAL OF MEDICINE 2012-03, Vol.366 (11), p.1000-1009
Hauptverfasser: Comi, Giancarlo, Jeffery, Douglas, Kappos, Ludwig, Montalban, Xavier, Boyko, Alexey, Rocca, Maria A, Filippi, Massimo
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Sprache:eng
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Zusammenfassung:In this placebo-controlled, phase 3 trial involving patients with relapsing–remitting multiple sclerosis, oral laquinimod administered once daily reduced the number of clinical relapses and slowed disability progression. Laquinimod is an oral quinoline-3-carboxamide small molecule selected for its efficacy and safety from a pool of 60 quinoline-3-carboxamide derivatives of the parent compound, roquinimex, a drug previously evaluated in phase 2 trials of treatment for multiple sclerosis but withdrawn because of safety concerns. 1 Preclinical studies have shown that laquinimod reduces inflammatory cell infiltrates in the central nervous system, decreases demyelination, and prevents axonal loss. 2 It is currently in clinical development for the treatment of multiple sclerosis. 3 – 7 A 36-week, double-blind, placebo-controlled, phase 2 clinical trial showed a significant reduction in the primary end point, the cumulative number of gadolinium-enhancing . . .
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMoa1104318