Oral Laquinimod Effective in Phase III Trial
The two-year ALLEGRO clinical trial was conducted at 139 sites in 24 countries and enrolled 1,106 MS patients. Patients were randomized to receive a once-daily oral dose of 0.6 mg laquinimod or placebo. Treatment with laquinimod resulted in less confirmed relapses than placebo. Treatment with laquinimod rather than placebo resulted in less likelihood of having confirmed disability progression and MRI active lesions.
A second clinical study, BRAVO, is a two-year, multi-center, randomized, double-blind, placebo-controlled study designed to compare a once-daily oral dose of 0.6 mg laquinimod and oral placebo plus another comparison group on Avonex . BRAVO enrolled 1,332 patients at 154 sites in the U.S, Europe, Israel and South Africa. BRAVO study results are expected in the third quarter of 2011. Submission to the FDA is planned after the results of BRAVO study are obtained.
BY: Barry Singer, MD DATE: December 13, 2010 TOPIC: MS Research News