Status:
COMPLETED
Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Partial Onset Seizures
Eligibility:
All Genders
4-14 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or pla...
Eligibility Criteria
Inclusion
- Male and female outpatients, aged 4 to 14 years (inclusive), with a minimum body weight of 15 kg.
- A diagnosis of partial onset seizures, which include the seizure subtypes of simple, complex, and secondarily generalized seizures (based on the International League Against Epilepsy (ILAE) Classification, as modified in 1981).
Exclusion
- A document history of generalized status epileptics in the past 6 months.
- Seizures having a metabolic, neoplastic, or active infectious origin.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00975715
Start Date
September 1 2009
End Date
October 1 2012
Last Update
July 16 2014
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 460-0004
2
Novartis Investigative Site
Ohbu, Aichi-ken, Japan, 474-0031
3
Novartis Investigative Site
Matsuyama, Ehime, Japan, 790-8524
4
Novartis Investigative Site
Fukuoka, Fukuoka, Japan, 814-0180