clinical trial · NCT04519645
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
UCB Biopharma SRL·phase2·terminated·n = 29
Electroencephalographic Neonatal SeizuresEpilepsyLacosamide intravenousLacosamide oralActive Comparator
brief summary
The purpose of the study is to evaluate the efficacy of lacosamide (LCM) versus an Active Comparator chosen based on standard of care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.
started
Mar 31, 2021
primary completion
Aug 6, 2024
completion
Oct 31, 2024
last updated
Oct 3, 2025
official title
A Multicenter, Open-Label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol