A Phase IIb Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Status:
Not yet recruiting
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
Summary
The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the
treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV)
to treat neonatal seizures is significantly greater than 60mg/kg. This study will be an open
label dose-escalation, preliminary safety and efficacy study. There will be a randomized
control treatment component. Infants recognized as having neonatal seizures or as being at
risk of developing seizures will be recruited and started on continuous video EEG monitoring
(CEEG). Eligibility will be confirmed and consent will be obtained. In the first 2 phases of
the study, neurologists will identify neonates with mild-moderate seizure burden (less than 8
minutes cumulative seizure activity per hour), appropriate for study with LEV, and exclude
patients with higher seizure burden where treatment with PHB is more appropriate. Phase 3 of
the dose escalation will only proceed if additional efficacy of LEV has been demonstrated in
phases 1 and 2. In Phase 3 we will recruit neonates with seizures of greater severity up to
30 minute seizure burden/hour. This will make the final results of study more generalizable.
If seizures are confirmed, enrolled subjects will receive 60mg/kg of LEV. Subjects whose
seizures persist or recur 15 minutes after the first infusion is complete, subjects will then
be randomized in the dose escalation study. Patients in the dose escalation study will be
randomly assigned to receive either higher dose LEV or treatment with the control drug PHB in
a 3:1 allocation ratio, stratified by site.
Phase:
Phase 2
Details
Lead Sponsor:
University of California, San Diego
Collaborators:
Auckland City Hospital Middlemore Hospital, New Zealand Rady Children's Hospital, San Diego Sharp Mary Birch Hospital for Women & Newborns University of Auckland, New Zealand University of Minnesota