Study of Valproate in Young Patients Suffering From Epilepsy

Phase 4

Completed

• Conditions: Epilepsy
• Interventions: Drug: valproate microgranules

• Registration Number: NCT00385411
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-10-06
• Study First Submitted QC: 2006-10-06
• Study First Posted: 2006-10-09
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-02
• Last Update Posted: 2009-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
valproate	valproate microgranules	-

Primary Outcome Measures

Name	Time	Method
Clinical and biological safety.	at each visit
Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate	Ancillary population kinetics study

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇫🇷 Paris, France