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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
20 to 30 mg/kg/day
Sanofi-Aventis Administrative Office
Paris, France
Clinical and biological safety.
Time frame: at each visit
Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate
Time frame: Ancillary population kinetics study
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