The test article for this study is levetiracetam (Keppra, which is commercially available.
Keppra is indicated for use as adjunctive therapy in the treatment of partial onset seizure
disorders in patients age four years and above. An intravenous dosage form of levetiracetam
is available for patients who are unable to take the oral form. UCB has conducted
pharmacokinetic studies in normal volunteers and one safety study in epileptic patients
using IV levetiracetam. These studies have shown a 1:1 ratio between doses of oral and
parental levetiracetam. In addition, several different infusion rates have been studied,
from five minutes to fifteen minutes with no significant safety concerns. These studies
were performed in adults age 16 and over. This was done because at the time when IV studies
were conducted, there was no pediatric approval However, since then a pediatric indication
has been approved, based on the results of a successful outpatient pediatric study in
children ages four to sixteen years, using levetiracetam as adjunctive therapy for partial
Each subject will receive open label levetiracetam.
- Subjects must have a confirmed diagnosis of either partial onset seizures or
generalized epilepsy and have received anti-epileptic drug therapy prior to
initiation of IV levetiracetam.
- Subjects must have a medical condition in which the rapid achievement of serum levels
with the use parenteral administration of levetiracetam is desirable. Such as in the
case of re-initiating drug therapy to achieve therapeutic serum levels of an
inpatient prior to discharge.
- Subject may be male or female.
- Subject must be four years of age or older, and less than age 23 years. This age is
indicative of the patient population typically treated at LeBonheur Children's
- Subject or his/her legally authorized representative must sign an informed consent
prior to any study-specific procedures.
- Subject has previously participated in any other intravenous levetiracetam study.
- Subject has status epilepticus within the last 6 months.
- Subject has a history of a drug allergy to levetiracetam.
- Subject is pregnant.
- Subject has taken an experimental drug within the last 30 days.