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Completed

NCT Number: NCT00385411

Study of Valproate in Young Patients Suffering From Epilepsy

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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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

valproate microgranules

Drug

20 to 30 mg/kg/day

Primary outcomes

  1. Clinical and biological safety.

    Time frame: at each visit

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

    Time frame: Ancillary population kinetics study

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Completed

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Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Acronym: VAPOP

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 9, 2006
Registry last updated
Oct 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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