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news.Belgium firm UCB has said a phase III study evaluating the efficacy and tolerability of its epilepsy drug Keppra as adjunctive therapy in the treatment of seizures in children.
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Compared with placebo, Keppra was shown to significantly reduce the frequency of partial onset seizures in pediatric patients from one month to less than four years of age, with consistent results across all stratified age groups.
“There are very few studies assessing antiepileptic drug efficacy in infants. In this well-designed randomized trial Keppra was shown to be more efficacious than placebo in controlling partial seizures in infants and young children with treatment resistant partial onset epilepsies,” commented, Jesus Eric Pina-Garza, director Pediatric Epilepsy Clinical Trials, Vanderbilt University.
In this study 43.1% of Keppra-treated patients experienced at least a 50% reduction in seizure frequency during the evaluation period compared with 19.6% of placebo-treated patients.
UCB said that on the basis of the positive results in younger patients with treatment resistant partial seizures, it intends to file a supplementary new drug application for Keppra.