Study of Valproate in Young Patients Suffering From Epilepsy

Epilepsy Clinical Trial

— VAPOP  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385411
• Other study ID #: L_8971
• Secondary ID: EudraCT #: 2005-
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2006
• Last updated: October 2, 2009
• Start date: March 2006
• Est. completion date: October 2008

Study information

• Verified date: October 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 15 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• valproate microgranules
20 to 30 mg/kg/day

Locations

Country	Name	City	State
France	Sanofi-Aventis Administrative Office	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and biological safety.		at each visit	Yes
Primary	Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate		Ancillary population kinetics study	No