Pharmacokinetics in Neonates Exposed to Lacosamide
Study Dates
2020-06 - 2020-12
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Publisher
PEDSnet
Abstract
Study intended to evaluate pharmacokinetic (PK) and seizure outcomes in neonates exposed to any dose of Lacosamide.
Affiliation(s)
Funder(s)
This research was made possible through the generous support of 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
- 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.
- To assess effectiveness outcomes in a non-comparative design, evaluating endpoints within 30 days of drug start. Any of the following can apply
- 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.
Development Code
Vocabulary
Clinical Subjects Headings
Creative Commons license
Except where otherwised noted, this item's license is described as a CC-BY 4.0 Attribution license.
Cite this Study
Forrest, C. & Abend, N. Pharmacokinetics in Neonates Exposed to Lacosamide. [Study]. PEDSpace Knowledge Bank. https://hdl.handle.net/20.500.14642/942