Status:
COMPLETED
Study of Valproate in Young Patients Suffering From Epilepsy
Lead Sponsor:
Sanofi
Conditions:
Epilepsy
Eligibility:
All Genders
6-15 years
Phase:
PHASE4
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00385411
Start Date
March 1 2006
End Date
October 1 2008
Last Update
October 6 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Paris, France