CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 280 enrolled
Drug / intervention
Intravenous levetiracetam +1 moredrug
Likely dose
Intravenous levetiracetam 60 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.

Search/NCT01720667
NCT01720667Phase 2Completed
CompareCT.gov

Efficacy of Intravenous Levetiracetam in Neonatal Seizures: A Phase 2 Randomized Blinded Controlled Study of the Efficacy of Intravenous Levetiracetam (LEV) as First Line Treatment for Neonatal Seizures

Richard H. Haas·interventional·Posted Nov 2, 2012·Updated Aug 21, 2019

In Brief

A Phase 2 clinical trial evaluating Intravenous levetiracetam and Intravenous phenobarbital for Neonatal Seizures. Completed, enrolled 280 participants across 1 site.

Detailed Summary

A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants. Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. Monitoring for seizure detection will be tested at five (5) US sites and one (1) international site using the internet.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Seizures
CountriesUnited States
CollaboratorsUniversity of California, San Diego, Rady Children's Hospital, San Diego, Auckland City Hospital, Sharp Mary Birch Hospital for Women & Newborns, UCSF Benioff Children's Hospital Oakland, Food and Drug Administration (FDA)

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2012
Enrollment StartMar 1, 2013
Primary CompletionOct 31, 2017
Study CompletionJul 31, 2019
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.7 years ago

Interventions

Intravenous levetiracetamdrug

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

Intravenous phenobarbitaldrug

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