A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
Childhood absence epilepsy (CAE) is a form of generalized epilepsy syndrome. Clinically these
seizures are manifest with a sudden, brief (3-15 second) loss of awareness followed by a
quick recovery to baseline. Keppra (levetiracetam) is approved by the U.S. Food and Drug
Administration (FDA) to treat partial seizures in adults. It is currently being studied in
children with partial seizures. Absence seizures can be difficult to detect clinically,
therefore the response to therapy will be determined both by clinical observation and by 24
hour EEG recordings. The researchers hope that with this information they will learn how well
it works for the treatment of childhood absence epilepsy and at what dose. This is an
open-label, dose-ranging pilot study of levetiracetam in subjects with newly diagnosed
childhood absence epilepsy. Approximately 20 patients will be needed to study effectiveness
and dose requirements. Subjects must not be on any antiepileptic medication at the time of
entry into the study. Male and female subjects from the ages of 4 to 10 years of age may
participate.