Study of Valproate in Young Patients Suffering From Epilepsy (VAPOP)
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|ClinicalTrials.gov Identifier: NCT00385411|
Recruitment Status : Completed
First Posted : October 9, 2006
Last Update Posted : October 6, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: valproate microgranules||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
Drug: valproate microgranules
20 to 30 mg/kg/day
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385411
|Sanofi-Aventis Administrative Office|
|Study Director:||Marie SEBILLE, Dr||Sanofi|