Efficacy of Intravenous Levetiracetam in Neonatal Seizures

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

October 31, 2017

Study Completion Date

July 31, 2019

Conditions
Neonatal Seizures
Interventions
DRUG

Intravenous levetiracetam

Intravenous load of levetiracetam (40 to 60 mg/kg) following identification of EEG confirmed neonatal seizure.

DRUG

Intravenous phenobarbital

Intravenous load of phenobarbital (20 to 40 mg/kg) following EEG confirmation of seizure activity load.

Trial Locations (1)

92103

University of California, San Diego Medical Center / Neonatal Intensive Care Unit (NICU), San Diego

All Listed Sponsors
collaborator

University of California, San Diego

OTHER

collaborator

Rady Children's Hospital, San Diego

OTHER

collaborator

Auckland City Hospital

OTHER_GOV

collaborator

Sharp Mary Birch Hospital for Women & Newborns

OTHER

collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

collaborator

Food and Drug Administration (FDA)

FED

lead

Richard H. Haas

OTHER

NCT01720667 - Efficacy of Intravenous Levetiracetam in Neonatal Seizures | Biotech Hunter | Biotech Hunter