NCT01239212

Dosing of Levetiracetam (Keppra) in Neonates

Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.

Conditions

• Seizures

Interventions

Type	Name	Description
DRUG	levetiracetam	50 mg/kg single loading dose of IV levetiracetam

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-11-11
• Last updated: 2021-09-05
• Results posted: 2014-09-08

Locations

1 site across 1 country: United States