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European approval given for Keppra use in children with epilepsy

28 September, 2005

The European Commission
has approved the use of the anti-epileptic drug Keppra (levetiracetam)
in the European Union. Its licence will allow it to be used as an
add-on therapy in the treatment of partial-onset seizures in children
from four to sixteen years of age.

Approval was based on a clinical trial, the results of which were most recently reported at the European Paediatric Neurology Society Congress in Gothenburg.

The
clinical trial was of 198 children with partial-onset seizures whose
epilepsy was not controlled by other anti-epileptic drugs. The results
showed that 45 per cent of those who received levetiracetam for 14
weeks had at least a 50 per cent reduction in seizure frequency, and
seven per cent became seizure free.

Dr Tracy Glauser, director of the Comprehensive Epilepsy Program at Cincinnati Children's Hospital and principal investigator of the study, commented:

"More
than 25 per cent of children with epilepsy experience treatment
resistant seizures or intolerable side effects from medication. Keppra
was effective and well-tolerated by children in the study, many of whom
had tried multiple anti-epileptic drugs prior to trying Keppra."