Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

753

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 years study duration

Study Start

First participant enrolled

June 19, 2017

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed

6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

6 years

First QC Date

June 20, 2017

Last Update Submit

November 17, 2025

Conditions

Epilepsy

Keywords

antiepilepticspharmacokineticschildrengenetic polymorphisms

Outcome Measures

Primary Outcomes (3)

Volume of distribution
through study completion, an average of 5 years
Absorption constant
through study completion, an average of 5 years
Clearance
through study completion, an average of 5 years

Secondary Outcomes (1)

Composite measure of the inter-individual variability
through study completion, an average of 5 years

Study Arms (2)

antiepileptics titration

Titration of valproic acid, carbamazepine, phenobarbital, phenytoin, levetiracetam, lamotrigine, topiramate, oxcarbazepine, stiripentol, clobazam, brivaracétam, felbamate, lacosamide, rufinamide, gabapentine, pregabaline, sultiame, tiagabine, vigabatrine, mesuximide, primidone, perampanel, ethosuximide, zonisamide and cannabidiol

Biological: Valproic acidBiological: carbamazepineBiological: phenobarbitalBiological: phenytoinBiological: levetiracetamBiological: lamotrigineBiological: topiramateBiological: oxcarbazepineBiological: stiripentolBiological: clobazamBiological: brivaracétamBiological: felbamateBiological: lacosamideBiological: rufinamideBiological: gabapentineBiological: pregabalineBiological: sultiameBiological: tiagabineBiological: vigabatrineBiological: mesuximideBiological: primidoneBiological: perampanelBiological: ethosuximideBiological: zonisamideBiological: cannabidiol