Study of Valproate in Young Patients Suffering From Epilepsy (VAPOP)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Epilepsy

Treatments: Drug: valproate microgranules

Study type: Interventional

Funder types: Industry

Identifiers

NCT00385411

L_8971

EudraCT #: 2005-004041-33

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 6 months to 15 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

valproate

Experimental group

Treatment:

Drug: valproate microgranules