Pharmacokinetics in Neonates Exposed to Lacosamide

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dc.contributorUCB Pharma (United States)
dc.contributor.authorForrest, Christopher
dc.contributor.authorAbend, Nick
dc.contributor.otherChildren's Hospital of Philadelphia
dc.date.accessioned2025-01-10T20:24:57Z
dc.descriptionAn epidemiological neonatal seizure study evaluating pharmacokinetics (PK) and effectiveness outcome to support development of a clinical trial and provide evidence for the clinical and patient community. The study will include all neonates initially exposed to IV Lacosamide (Vimpat®) in PEDSnet and PCORnet. #### Study Aims 1. To obtain measurements of PK of LCM (plasma concentration) by obtaining drug dosing with time stamps and blood tests with time stamps at any time during the first observable episode of exposure to LCM and thereafter up to 30 days. 2. To assess effectiveness outcomes in a non-comparative design, evaluating endpoints within 30 days of drug start. Any of the following can apply 3. To estimate the incidence of the selected medical events #### Study Design A retrospective descriptive cohort study conducted using EHR data from the PEDSnet and PCORnet systems extracted between 2009-01-01 to 2019-12-31. #### Cohort Description The study population includes neonates aged under 30 days identified in the PEDSnet and PCORnet databases. Neonates are included who were born at term and preterm. Neonates are not included who were born at less than 35 weeks of gestational age as seizure in such preterm neonates is not considered to have the same etiology as other neonates and would not respond to AED. Inclusion Criteria: - Neonates less that 30 days calendar age (or gestational age equivalent) at index date, but greater than 35 weeks gestational age. - Males and females - Treated with iv LCM (any dose). Exclusion Criteria: - Patients outside the neonatal age range at index date. - Patients born very preterm (less than 35 weeks).
dc.description.abstractStudy intended to evaluate pharmacokinetic (PK) and seizure outcomes in neonates exposed to any dose of Lacosamide.
dc.identifier.urihttps://pedsnet.org/metadata/handle/20.500.14642/942
dc.publisherPEDSnet
dc.relation.isreferencedbyKaur M, Utidjian L, Abend NS, Dickinson K, Roebling R, et al. June 2024. "Retrospective Multicenter Cohort Study on Safety and Electroencephalographic Response to Lacosamide for Neonatal Seizures". _Pediatric Neurology_. 155:18-25. <br> DOI: [10.1016/j.pediatrneurol.2024.03.007](https://www.doi.org/10.1016/j.pediatrneurol.2024.03.007)
dc.rightsa CC-BY 4.0 Attribution license.
dc.rights.urihttps://creativecommons.org/licenses/by-sa/4.0/
dc.subjectStudy::Funded Study::PEDSnet Study
dc.subjectStudy::Cohort Study::Retrospective Study
dc.subject.meshPharmacokinetics
dc.subject.meshPharmacological and Toxicological Phenomena
dc.subject.meshMetabolism
dc.subject.meshAnticonvulsants
dc.subject.meshEpilepsy
dc.subject.meshBrain Diseases
dc.subject.meshCentral Nervous System Agents
dc.titlePharmacokinetics in Neonates Exposed to Lacosamide
dspace.entity.typeStudy
local.admin.noteThe PM for this project is Jill McDonald
local.subject.flatPEDSnet Data Source
local.subject.flatRetrospective Study
local.subject.flatCohort Study
local.subject.flatIndustry-Funded Research
project.endDate2020-12
project.startDate2020-06
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