Future Studies
The protocols for two randomized controlled phase IV trials of the use of levetiracetam in children have been recently published on-line. Lyttle and colleagues described the EcLiPSE study, which will compare levetiracetam and phenytoin for the treatment of pediatric status epilepticus.[15] In this multicenter open-label comparator trial, at least 308 children 6 months of age and older will be randomized to receive intravenous doses of either phenytoin (20 mg/kg) or levetiracetam (40 mg/kg). The primary outcome will be time to cessation of seizures, with secondary outcomes including the need for additional AEDs and the presence of continued seizures resulting in the need for intubation.
Dalziel and colleagues, writing for the PREDICT research network, described their convulsive status epilepticus pediatric trial (ConSEPT).[16] This study will enroll 200 children 3 months to 16 years of age in Australia and New Zealand with status unresponsive to benzodiazepines. Patients will receive either phenytoin or levetiracetam using the same doses as the EcLiPSE trial. The primary outcome will be clinical cessation of seizures within 5 minutes of dose administration. Secondary outcomes will be seizure activity at two hours, time to seizure cessation, need for intubation, and need for intensive care unit admission.
Pediatr Pharm. 2018;24(7) © 2018 University of Virginia
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