Population Pharmacokinetics of Antiepileptic in Pediatrics
NCT03196466 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 753
Last updated 2025-11-20
Summary
The purpose of this study is to develop population pharmacokinetic models for antiepileptic drugs in a pediatric population.
The interest of these models is multiple:
* describe the pharmacokinetics of these molecules in children and explain the inter-individual variability of concentrations through covariates such as weight, age, co-treatments, genetic polymorphisms and renal function;
* estimate maximum, minimum and exposure concentrations from the individual pharmacokinetic parameters for each patient;
* propose adaptations of doses for certain classes of children (according to age, weight etc.) and individualize the doses.
Conditions
Interventions
- BIOLOGICAL
-
Valproic acid
titration
- BIOLOGICAL
-
carbamazepine
titration
- BIOLOGICAL
-
phenobarbital
titration
- BIOLOGICAL
-
phenytoin
titration
- BIOLOGICAL
-
titration
- BIOLOGICAL
-
lamotrigine
titration
- BIOLOGICAL
-
topiramate
titration
- BIOLOGICAL
-
oxcarbazepine
titration
- BIOLOGICAL
-
stiripentol
titration
- BIOLOGICAL
-
clobazam
titration
- BIOLOGICAL
-
brivaracétam
titration
- BIOLOGICAL
-
felbamate
titration
- BIOLOGICAL
-
lacosamide
titration
- BIOLOGICAL
-
rufinamide
titration
- BIOLOGICAL
-
gabapentine
titration
- BIOLOGICAL
-
pregabaline
titration
- BIOLOGICAL
-
sultiame
titration
- BIOLOGICAL
-
tiagabine
titration
- BIOLOGICAL
-
vigabatrine
titration
- BIOLOGICAL
-
mesuximide
titration
- BIOLOGICAL
-
primidone
titration
- BIOLOGICAL
-
perampanel
titration
- BIOLOGICAL
-
ethosuximide
titration
- BIOLOGICAL
-
zonisamide
titration
- BIOLOGICAL
-
cannabidiol
titration
- OTHER
-
genetic polymorphisms
genetic polymorphisms
Sponsors & Collaborators
-
URC-CIC Paris Descartes Necker Cochin
collaborator OTHER -
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Jean-Marc TRELUYER, MD, PhD · Assistance Publique - Hôpitaux de Paris
Eligibility
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-19
- Primary Completion
- 2023-06-15
- Completion
- 2023-06-15
Countries
- France
Study Locations
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