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