Abstracts

Rationale: There are only a limited number of intravenous antiepileptic drugs available for the treatment of status epilepticus. Performing human studies in the current regulatory environment is almost impossible without some evidence that the new agent may be effective and potentially superior to existing therapy. A previous PK study in dogs determined that a loading dose of 30 mg/kg should give peak levels of approximately 50 ug/ml. This, current canine study, is a proof of concept study whose results will be used to initiate a human study. Methods: The Veterinary Medical Center of the U of MN has approximately 4-6 dogs per month with naturally occurring epilepsy who present for the emergency treatment of status epilepticus or acute repetitive seizures. Informed consent will be obtained from the owners. Dogs who have failed initial benzodiazepam treatment will be randomized to an infusion of 30 mg/kg of the formulation of levetiracetam approved for human use or a similar volume of saline. Dogs will be observed for 24 hours in a companion animal intensive care unit. A total of 20 dogs will be randomized. Results: Nine dogs have been treated. Three continued to have seizures during the initial 24 hours, and 6 have been completely controlled for 24 hours. We expect all of the 20 canine patients will have been entered and the blind broken by the time of the meeting. Conclusions: This proof of concept study may provide the evidence needed to launch a study of levetiracetam for human status epilepticus/acute repetitive seizures. Funded by the American Kennel Club Canine Health Foundation