Status:
COMPLETED
Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures
Lead Sponsor:
Novartis
Conditions:
Epilepsy, Partial Seizures
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
This study is aimed to collect additional data regarding the efficacy in reducing the frequency of partial seizures, as well as the safety and tolerability, of oxcarbazepine monotherapy in children.
Eligibility Criteria
Inclusion
- males and females, 6 months - 17 years of age;
- diagnosis of epilepsy, partial seizures;
- ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous antiepileptic therapy
Exclusion
- progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening;
- non-epileptic seizures;
- drug or alcohol dependence during a year prior to screening;
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
September 11 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00275912
Start Date
September 11 2006
End Date
September 28 2007
Last Update
February 23 2017
Active Locations (5)
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1
Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery
Moscow, Russia
2
Russian State Medical University clinically based on Russian Pediatric Clinical Hospital
Moscow, Russia
3
Scientific-practical centre of children treatment suffering from craniofacial malformation and congenital pathology of nervous system
Moscow, Russia
4
St. Petersburg State Pediatrics Medical Academy
Saint Petersburg, Russia