Study of Valproate in Young Patients Suffering From Epilepsy

Summary

Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of valproate administered as microgranules, under standard prescription conditions, with therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations and antiepileptic comedication as well as biological assays. Secondary objectives: Ancillary population kinetics study * Estimate the pharmacokinetic parameters of valproate administered as microgranules under standard therapeutic conditions within the population studied, from the therapeutic follow-up data. * Evaluate the influence of individual characteristics on the pharmacokinetic parameters. * Describe the relationship between plasma concentrations and adverse events for valproate and the main anti-epileptic comedications.

Timeline

Start

2006-03

Primary completion

2008-10

Completion

2008-10

Drugs

Indications