Brussels, Belgium (ots/PRNewswire) - Today UCB announced that the
European Commission has approved the use of Keppra(R) (levetiracetam)
in the European Union, as adjunctive therapy in the treatment of
partial-onset seizures, with or without secondary generalisation, in
children from four to sixteen years of age.
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
"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
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).
(a) Note to Editors
Results of this pivotal clinical trial were previously reported in
the US at the 58th American Epilepsy Society Congress in December
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.
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.
UCB - www.ucb-group.com - is a global biopharmaceutical leader
with headquarters in Brussels, Belgium, specializing in the fields of
central nervous system disorders, allergy and respiratory diseases,
immune and inflammatory disorders, as well as oncology. UCB key
products are Keppra(R) (antiepileptic), Xyzal(R) and Zyrtec(R)
(antiallergics), Nootropil(R) (cerebral function regulator),
Tussionex(TM) CIII (antitussive) and Metadate CD(TM) CII /
Equasym(TM) XL (attention-deficit/hyperactivity disorder). UCB
employs over 8,500 people operating in over 40 countries. UCB is
listed on Euronext Brussels.
ots Originaltext: UCB
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