NCT01261416

Pharmacokinetics of Levetiracetam (Keppra) in Neonates

Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (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 loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of levetiracetam in term and preterm infants with seizures.

Conditions

• Seizures
• Epilepsy

Interventions

Type	Name	Description
DRUG	levetiracetam	Patients will receive levetiracetam as needed for clinical and/or electrographic seizures. Need for levetiracetam will be determined by the clinical team and will NOT determined by the study protocol.

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-12-16
• Last updated: 2010-12-16

Locations

1 site across 1 country: United States