Lacosamide in neonates with electroencephalographic neonatal seizures
Principal Investigator : Prof. Geraldine Boylan
The LENS Study
The LENS Study is a multi-centre, randomised clinical study to evaluate the efficacy, safety, and pharmacokinetics of an antiepileptic drug (Lacosamide) in neonates with repeated seizures. Lacosamide will be evaluated against a number of existing AEDs currently in clinical use.
The study is being conducted in over 25 hospitals across the United States and Australia. Once a neonate has fulfilled the screening criteria, a video EEG recording is taken and uploaded to the study site. Working with our industry partners the files are then downloaded to a secure location for analysis.
The research team at INFANT, led by Prof Geraldine Boylan and Dr Sean Mathieson review the recordings and annotate over 50 hours of vEEG looking for the presence of seizure in the 2 hours prior to the study drug administration and in the 48 hours after the dosage. At least two EEG experts review each recording and once they have reached agreement the results are uploaded to the study site within 48 hours of download.