Status:
COMPLETED
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Partial Epilepsy in Children and Adolescents
Eligibility:
All Genders
2-16 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose conditio...
Detailed Description
Partial epilepsy, the commonest form of epilepsy, is a difficult condition to treat with many patients continuing to have symptoms despite trying several medications. Lack of efficacy and adverse effe...
Eligibility Criteria
Inclusion
- girls of child-bearing potential have to follow reliable and medically acceptable contraceptive method throughout the study
- diagnosis of epilepsy for at least 6 months prior to enrolment
- at least 4 partial-onset seizures in the last month prior to enrolment despite stable therapy with adequate dosage of 1 or 2 AEDs
- at least 4 partial-onset seizures during each 4-week interval of the 8-week baseline period
- previous treatment with three or more AEDs, in their maximum tolerated doses, for at least one month, without seizure control
- current treatment with 1 or 2 AEDs (any except oxcarbazepine); if present, vagus nerve stimulation is considered an AED
- stable dose regimen of AEDs during the 8-week baseline period
- cooperation and willingness to complete all aspects of the study, including hospitalisation if required
- written informed consent to participate in the study in accordance with local legislation
Exclusion
- primarily generalised seizures
- baseline seizure frequency substantially different from usual seizure frequency
- known progressive neurological disorders
- history of status epilepticus within the 3 months prior to enrolment
- seizures of non-epileptic origin
- Lennon-Gastaut
- West syndrome
- Major psychiatric disorders
- Previous treatment any study with Eslicarbazepine acetate
Key Trial Info
Start Date :
December 7 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2017
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00988156
Start Date
December 7 2007
End Date
August 24 2017
Last Update
November 13 2018
Active Locations (91)
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1
Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz
Graz, Austria, 8036
2
Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien
Vienna, Austria, 1090
3
Clinical Centre Banja Luka Pediatric Clinic Department of Neurology
Banja Luka, Bosnia and Herzegovina, 78000
4
Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department
Sarajevo, Bosnia and Herzegovina, 71000