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Published on: June 11, 2020
Retrospective Multicenter Cohort Study on Safety and Electroencephalographic Response to Lacosamide for Neonatal
Moninder Kaur1, Levon Utidjian2, Nicholas S Abend3
1RWE Neurology, UCB Pharma Ltd, Slough, UK; Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
Insights
Lacosamide appears safe for neonates, with observed adverse events comparable to other treatments. Seizure response varied, indicating a need for further research into its efficacy in this population.
Area of Science:
- Neonatal neurology
- Pediatric pharmacology
- Clinical epilepsy research
Background:
- Limited data exists on lacosamide use in neonates, despite evidence of safety and effectiveness in older children.
- This study addresses the gap in knowledge regarding lacosamide's safety and electroencephalographic (EEG) seizure response in neonates.
Purpose of the Study:
- To determine the incidence of adverse events associated with lacosamide in neonates.
- To explore the EEG seizure response to lacosamide in neonates.
Main Methods:
- A retrospective cohort study analyzed data from seven pediatric hospitals (January 2009 - February 2020).
- Neonates were monitored for adverse events for up to 30 days post-treatment.
- EEG seizure response was assessed using EEG reports within 3 days of lacosamide administration.
Main Results:
- Out of 47 neonates, 19% died during a median 12-day follow-up; 98% received lacosamide in intensive care units.
- Adverse event incidence rates per 1000 patient-days ranged from 2.8 for blood/lymphatic/nervous system disorders to 10.5 for cardiac disorders.
- EEG seizures were present in 31/34 neonates; seizure improvement was noted in 29% on days 1 and 2, with no change or unknown change by day 3.
Conclusions:
- Lacosamide use in neonates appears safe, with adverse event rates not exceeding expectations.
- Preliminary efficacy findings suggest some neonates experienced reduced seizures, but a lack of a control group and reliance on qualitative EEG reports limit definitive conclusions.
- Further research with a comparator arm is needed to establish lacosamide's efficacy in neonatal seizures.
Background:
There is growing evidence supporting the safety and effectiveness of lacosamide in older children. However, minimal data are available for neonates. We aimed to determine the incidence of adverse events associated with lacosamide use and explore the electroencephalographic seizure response to lacosamide in neonates.
Methods:
A retrospective cohort study was conducted using data from seven pediatric hospitals from January 2009 to February 2020. For safety outcomes, neonates were followed for ≤30 days from index date. Electroencephalographic response of lacosamide was evaluated based on electroencephalographic reports for ≤3 days.
Results:
Among 47 neonates, 98% received the first lacosamide dose in the intensive care units. During the median follow-up of 12 days, 19% of neonates died, and the crude incidence rate per 1000 patient-days (95% confidence interval) of the adverse events by diagnostic categories ranged from 2.8 (0.3, 10.2) for blood or lymphatic system disorders and nervous system disorders to 10.5 (4.2, 21.6) for cardiac disorders. Electroencephalographic seizures were observed in 31 of 34 patients with available electroencephalographic data on the index date. There was seizure improvement in 29% of neonates on day 1 and also in 29% of neonates on day 2. On day 3, there was no change in 50% of neonates and unknown change in 50% of neonates.
Conclusions:
The results are reassuring regarding the safety of lacosamide in neonates. Although some neonates had fewer seizures after lacosamide administration, the lack of a comparator arm and reliance on qualitative statements in electroencephalographic reports limit the preliminary efficacy results.
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