Understanding how antiepileptic drugs work in children
Population Pharmacokinetics of Antiepileptic in Pediatrics
This study is trying to understand how different factors affect the way antiepileptic drugs work in children with epilepsy to help doctors give the right dose for each child.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT03196466 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop population pharmacokinetic models for various antiepileptic drugs in a pediatric population. It focuses on understanding how factors like age, weight, genetic differences, and co-treatments affect drug concentrations in children with epilepsy. By analyzing data from blood samples collected over several years, the study seeks to provide insights into optimal dosing strategies tailored to individual patients. The ultimate goal is to improve the management of epilepsy in children by individualizing treatment based on pharmacokinetic parameters.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 18 years who are currently being treated with one or more of the specified antiepileptic drugs.
Not a fit: Patients who may not benefit from this study include those with incomplete data regarding their medication adherence or treatment history.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment plans for children with epilepsy.
How similar studies have performed: Other studies have shown success in using population pharmacokinetics to optimize drug dosing in pediatric populations, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children from 0 to 18 years of age with epilepsy; * Treatment with one or more antiepileptic drug (s) studied (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); * Blood dosage of the drug (s) as part of their therapeutic follow-up in the Pharmacology laboratory of the Cochin hospital between 2007 and 2019 Exclusion Criteria: * patient with missing data on time of last drug taking, time of collection, co-treatments and / or dose administered; * patient with doubt about compliance
Where this trial is running
Paris
- AP-HP Cochin — Paris, France (Recruiting)
Study contacts
- Principal investigator: Jean-Marc TRELUYER, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Jean-Marc TRELUYER, MD, PhD
- Email: jean-marc.treluyer@aphp.fr
- Phone: 01 58 41 28 84
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.