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UCB Announces Positive Top-Line Phase III Results for Keppra as,Adjunctive Therapy for Partial Onset Seizures in Paediatric,Patients from One Month to Less than Four Years of Age

ur video EEG performed at baseline and at the end of the evaluation period with seizures identified and recorded by a central reader.

Fifty million people worldwide have epilepsy[2]. Childhood epilepsy is among the most prevalent neurological conditions. The effects of epilepsy on a child's psychological and social development are complex and cover all dimensions of a child's life and future.

Peter Verdru, Vice President, CNS Clinical Development, UCB said, 'This is the second double-blind, randomized, placebo-controlled trial of Keppra® in children, with studies in partial onset seizures now extending from infancy through adulthood.' He continued, 'This trial was designed and conducted in close collaboration with the regulatory authorities. On the basis of these positive results in younger patients with treatment resistant partial seizures we intend to file a supplementary new drug application for Keppra®'.

About Keppra® in the US[3],[4] Keppra® tablets and oral solution are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy, as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy, and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy (IGE). Keppra® tablets and oral solution are associated with the occurrence of central nervous system adverse events including somnolence and fatigue, co-ordination difficulties and behavioral abnormalities as well as hematological abnormalities. In adults experiencing partial onset seizures, the most common adverse events associated with Keppra® in combination with other antiepileptic drugs (AEDs) were somnolence, asthenia, infection and dizziness. In pediatric patients 4-16 years of age experiencing
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