www.fdanews.com/articles/101756-ucb-s-keppra-reduces-seizure-frequency-in-trial
UCB's Keppra Reduces Seizure Frequency in Trial
December 4, 2007
Belgian drugmaker UCB’s anti-epileptic drug Keppra reduced partial onset seizure frequency when administered as adjunctive therapy for adults with refractory epilepsy in a Phase III trial.
The 158-patient, multicenter, randomized, double-blind, placebo-controlled study evaluated extended-release Keppra (levetiracetam) tablets once daily in patients 12–70 years of age.
The study met its primary endpoint for seizure reduction versus placebo during the treatment period. The median percent reduction of partial onset seizures in the Keppra group was 46.1 percent compared with 33.4 percent in the placebo group, UCB said.
UCB will submit a new drug application for this indication to the FDA.