Epilepsy Clinical Trial
Official title:
Therapeutic Follow-up Observational Study and Population Kinetics Ancillary Study of Valproate Microgranules (Micropakine® SR) in Patients Aged Between 6 Months and 15 Years Suffering From Epilepsy.
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.
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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