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European Commission Approves Keppra as Adjunctive Therapy in Children With Partial-Onset Seizures
Approval was based on a pivotal paediatric clinical trial, the results of which were most recently(a) reported at the 6th European Paediatric Neurology Society Congress (14th-17th September 2005), in Sweden(1).
"More than 25% of children with epilepsy experience treatment resistant seizures or intolerable side effects from medication" said Tracy Glauser, M.D., director of the Comprehensive Epilepsy Program, Cincinnati Children's Hospital and principal investigator of the study. "Keppra(R) was effective and well-tolerated by children in the study, many of whom had tried multiple anti-epileptic drugs prior to trying Keppra(R)."
The trial was a multicentre, double-blind, randomized, placebo-controlled study in 198 children (4-16 years old), with partial onset seizures with or without secondary generalisation uncontrolled by standard AEDs. Results show that 45% of those who received levetiracetam at a target dose of 60 mg/kg/day for 14 weeks had at least a 50% reduction in seizure frequency, and 7% became seizure free(1). This compared with 19% (p=0.0002) and 1% respectively in placebo-treated patients. Prior to treatment with levetiracetam, the children enrolled in the study were experiencing approximately five seizures per week (median = 4.7 and 5.3 for the levetiracetam and placebo group respectively)(1).
Levetiracetam was well tolerated, and fewer children withdrew from treatment with levetiracetam because of adverse events compared to the placebo group (5% and 9% withdrawal for the levetiracetam and placebo group, respectively)(1). With the exception of somnolence (22.8% and 11.3% for the levetiracetam and placebo group, respectively), the incidence of treatment related adverse events was similar between patients in the levetiracetam and placebo groups with the most commonly reported treatment adverse events being somnolence, infection, accidental injury, vomiting and headache(1).
Results of this pivotal clinical trial were previously reported in the US at the 58th American Epilepsy Society Congress in December 2004(2).
In the US and Europe, Keppra(R) (levetiracetam) is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children four years of age and above with epilepsy. In adults, the use of Keppra(R) is associated with the occurrence of central nervous system adverse events including somnolence and fatigue, coordination difficulties, and behavioral abnormalities, as well as hematological abnormalities. In paediatric patients 4 to 16 years of age, Keppra(R) is associated with somnolence, fatigue and behavioural abnormalities, as well as hematological abnormalities. In adults, the most common adverse events associated with Keppra(R) in combination with other AEDs are somnolence, asthenia, infection, and dizziness. Of these, most appeared to occur predominantly during the first 4 weeks of treatment. In pediatric patients 4 to16 years of age, the most common adverse events associated with Keppra(R) in combination with other AEDs are somnolence, accidental injury, hostility, nervousness, and asthenia.
1. Lu Z, Glauser TA, Ayala R, Elterman RD, Mitchell WG, Van Orman CB, Gauer LJ Levetiracetam adjunctive therapy in children with refractory partial epilepsy, in comparison with other new anti-epileptic drugs. Poster Presentation at the 6th European Paediatric Neurology Society Congress, Goteborg, September 2005.
2. Glauser TA, Gauer LJ, Chen L LEV N159 Pediatric Study Group Multicenter double-blind, placebo-controlled trial of adjunctive levetiracetam (Keppra(R)) therapy (up to 60 mg/kg/day) in pediatric patients with refractory partial epilepsy. Presentation at the 58th American Epilepsy Society Congress, New Orleans, 6 December 2004.