Pharmacokinetics in Neonates Exposed to Lacosamide

Study Dates

2020-06 - 2020-12

Last Modified

Tags




Publisher

PEDSnet

Abstract

Study intended to evaluate pharmacokinetic (PK) and seizure outcomes in neonates exposed to any dose of Lacosamide.

Affiliation(s)

Children's Hospital of Philadelphia

Funder(s)

This research was made possible through the generous support of the UCB Pharma (United States) .

Provenance

Description

An 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).

Development Code

Vocabulary

Clinical Subjects Headings

Pharmacokinetics
Pharmacological and Toxicological Phenomena
Metabolism
Anticonvulsants
Epilepsy
Brain Diseases
Central Nervous System Agents

Related Concept Set

Related Person

Related Data Quality Result

Related Person

Related Phenotype

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Related Publications

Kaur 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.
DOI: 10.1016/j.pediatrneurol.2024.03.007

Creative Commons license

a CC-BY 4.0 Attribution license.
Except where otherwised noted, this item's license is described as a CC-BY 4.0 Attribution license.