Study of Valproate in Young Patients Suffering From Epilepsy

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00385411

Acronym

VAPOP

Enrollment

Registered

2006-10-09

Start date

2006-03-31

Completion date

2008-10-31

Last updated

2009-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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.

Interventions

DRUGvalproate microgranules

20 to 30 mg/kg/day

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 15 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026