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 condition has not been controlled by other drug treatments.
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 effects are commonly associated with current anti-epileptic drugs. This study will examine the efficacy in addition to safety and tolerability of a new anti-epileptic drug, Eslicarbazepine acetate (BIA 2-093), as an adjunctive therapy for refractory partial seizures in children. The primary analysis variables are: * The responder rate (the proportion of patients with at least a 50% reduction in standardised seizure frequency) * The relative reduction in standardised seizure frequency
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
304
Part I - 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period. The recommended target dose of double-blind study treatment will be 20mg/kg/day. Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year.
Part I: 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period. Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year.
Change From Baseline in Seizure Frequency
Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
Time frame: Baseline up to Visit 7
Responder Rate
Responder rate defined as the number of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
Time frame: baseline up to Visit 7
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Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz
Graz, Austria
Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien
Vienna, Austria
Clinical Centre Banja Luka Pediatric Clinic Department of Neurology
Banja Luka, Bosnia and Herzegovina
Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department
Sarajevo, Bosnia and Herzegovina
Clinical hospital Osjek Pediatric clinic, neuropediatric department
Osijek, Croatia
Clinic for Children Diseases Zagreb
Zagreb, Croatia
Clinic for Sick Children "Dr. Sabol"
Zagreb, Croatia
Clinic of the Child Neurology, FN Brno
Brno, Czechia
Neurology Policlinic
Hradec Králové, Czechia
Child Neurology Clinic of the DNsP Ostrava
Ostrava, Czechia
...and 81 more locations