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Study of Valproate in Young Patients Suffering From Epilepsy

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: valproate microgranules (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Marie SEBILLE, Dr, Study Director, Affiliation: Sanofi


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.

Clinical Details

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 design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Clinical and biological safety.

Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate


Minimum age: 6 Months. Maximum age: 15 Years. Gender(s): Both.


Inclusion Criteria:

- Children aged between 6 months and 15 years.

- Suffering from any type of epilepsy.

- Receiving at the time of inclusion valproate in the form Micropakine® SR 20 to 30

mg/kg/d by oral route, in 2 daily administrations and at most two other antiepileptic drugs (an antiepileptic benzodiazepine treatment taken daily or on demand more than 2 times weekly, must be considered as an antiepileptic treatment).

- Followed by hospital paediatricians or neuropaediatricians.

- For whom the consent has been signed by the parents or the holders of parental

authority and if possible by the child him/herself.

- For whom the parents or legal guardian do not have any language or cultural obstacle

for understanding the study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations and Contacts

Sanofi-Aventis Administrative Office, Paris, France
Additional Information

Starting date: March 2006
Last updated: October 2, 2009

Page last updated: August 20, 2015

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