Abstracts

Preliminary Results of a prospective trial of IV Keppra for Seizure Clusters

Abstract number : 3.172;
Submission category : 7. Antiepileptic Drugs
Year : 2007
Submission ID : 7918
Source : www.aesnet.org
Presentation date : 11/30/2007 12:00:00 AM
Published date : Nov 29, 2007, 06:00 AM

Authors :
J. I. Sirven1, J. F. Drazkowski1, K. Noe1, Y. Shareef1

Rationale: Rapid treatment of status epilepticus is crucial to prevent neurological and systemic morbidities that occur as a result of this condition. The goal of management is to immediately terminate seizures. Seizure clusters are a precursor to status epilepticus and are differentiated from this condition by the fact that there is an interval period of recovery between seizures. Levetiracetam is now available as an IV agent. IV Keppra does not have an FDA indication for use in status epilepticus. The objective of this study is to assess whether IV Keppra is both safe and effective for rapid termination of seizure clusters and in turn, prevention of status epilepticus. This data can be used for design of a larger trial to compare traditional agents versus IV Keppra for status epilepticus. Methods: This is a prospective, open-label observational study of IV Keppra for seizure clusters in adults. Seizure clusters are defined as a second seizure occurring within 3 hours of the onset of the first seizure. All adult patients who are admitted to Mayo Clinic Hospital with seizure clusters or status and on EEG monitoring within the hospital are eligible for the study (goal of N= 30). Once a seizure was noted, a time clock was established to assess if a second seizure occurred within 3 hours. If a second seizure occurred, the patient had an infusion of 1500 milligrams of IV Keppra delivered over a 5 minute infusion (permission from the FDA to dose in this manner). If a seizure persisted after the 5 minute levetiracetam infusion, a rescue dose of 2 milligrams of lorazepam was provided. All patients were monitored with EEG, EKG, vital signs, and serum labs were performed pre/ post infusion. All seizure and epilepsy types are eligible. Any NES events excluded the patient. The primary outcome measures are prevention of status and the time from onset of the second seizure to return to clinical baseline and need for rescue medication. Results: The following represents the initial observational analysis of the onset of this study. 15 patients were consented and 5 of 30 planned patients were enrolled into this study from 2/1/2007 through 4/30/2007. There were 3 males and 2 females with an average age of 26 years (range 19-42 years). Three patients had partial epilepsy of extratemporal origin and 2 patients had primary generalized epilepsy as manifested by generalized convulsions and atonic events. IV Keppra was able to terminate seizures in all 5 of the initial patients. The time to return to baseline after infusion was 4.2 minutes (range 2 minutes to 10 minutes). There were no changes in vital signs, Serum electrolytes and liver function studies did not reveal any abnormalities. No patients required rescue medication and none went into status epilepticus. EEG confirmed seizure termination in all patients. Conclusions: An early safety analysis of IV Keppra for seizure clusters shows both efficacy and safety at a dose of 1500 milligrams over 5 minutes. The return to clinical baseline is within 4 minutes with no prolongation of sedation or confusion.
Antiepileptic Drugs