At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 7 enrolled
Drug / intervention
levetiracetamdrug
Likely dose
levetiracetam 50 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates
Children's Hospital Medical Center, Cincinnati·interventional·Posted Nov 11, 2010·Updated Sep 5, 2021
In Brief
A Phase 2 clinical trial evaluating levetiracetam for Seizures. Completed, enrolled 7 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeizures
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedNov 2010
Primary CompletionJul 2011
TodayJul 2026
First PostedNov 11, 2010
Enrollment StartSep 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.6 years ago
Interventions
levetiracetamdrug
50 mg/kg single loading dose of IV levetiracetam