At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
Low dose levetiracetam +1 moredrug
Likely dose
Low dose levetiracetam 20 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.
Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures
In Brief
A Phase 2 clinical trial evaluating Low dose levetiracetam and High dose levetiracetam for Seizures and Disorder of Fetus or Newborn. Completed, enrolled 18 participants across 1 site.
Detailed Summary
The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeizures, Disorder of Fetus or Newborn
CountriesUnited States
CollaboratorsThrasher Research Fund
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
First PostedApr 2009
Primary CompletionMar 2011
Study CompletionOct 2011
TodayJul 2026
First PostedApr 20, 2009
Enrollment StartApr 1, 2007
Primary CompletionMar 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 17.2 years ago
Interventions
Low dose levetiracetamdrug
20 mg/kg loading dose; 5 mg/kg daily for 7 days.
High dose levetiracetamdrug
40 mg/kg IV load; 10 mg/kg/day maintenance