Study of Valproate in Young Patients Suffering From Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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valproate

Group Type EXPERIMENTAL

valproate microgranules

Intervention Type DRUG

20 to 30 mg/kg/day

Interventions

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valproate microgranules

20 to 30 mg/kg/day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No