The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate in children and adolescents with epilepsy.
This clinical study was planned to be performed as an open-label, single-centre, multiple-dose study, in 30 paediatric epileptic patients distributed by 3 age groups of 10 patients each: 2-6 years \[Group 1\], 7-11 years \[Group 2\], and 12-17 years \[Group 3\]. The study was constituted by a 4-week baseline phase, followed by 3 consecutive 4-week treatment periods with Eslicarbazepine acetate in which patients received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day (weeks 1-4), 15 mg/kg/day (weeks 5-8) and 30 mg/kg/day or 1800 mg/day, whichever less (weeks 9-12). At the end of each 4-week treatment period, patients were hospitalised and serial blood samples for drug assays were obtained over a dosing interval. After the last treatment period or in the event of premature discontinuation, the dose had to be down-titrated during a 2-week period. After the last treatment period patient could continue receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s) /patient and his/her physician agreed this was in the best patient's interest. A follow-up visit occurred approximately 4 weeks after the last hospitalisation or early discontinuation.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Eslicarbazepine acetate administered at increasing daily doses of 5 mg/kg, 15 mg/kg, and 30 mg/kg (or 1800 mg, whichever less); once-daily; oral route
Clinica de Neurologie Pediatrica, Spitalul "Alexandru Obregia"
Bucharest, Romania
Maximum Observed Plasma Drug Concentration (Cmax) Post-dose
Time frame: pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose
Time of Occurrence of Cmax (Tmax).
Time frame: pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose
Percentage Change in Seizure Frequency During Each 4-week Treatment Period Compared to the Baseline Phase
The efficacy variables were the percentage change in seizure frequency during each 4-week treatment period compared to the baseline phase. Seizures were recorded in the patient's diary during the baseline phase and during the following 4-week treatment periods. Seizure frequency for each patient was standardised to a frequency per 28 days period (i.e., mean daily frequency multiplied by 28). Changes in seizure frequency were analysed for each age group separately.
Time frame: Baseline, end of 5 mg/kg/day treatment period (4 weeks), 15 mg/kg/day treatment period (4 weeks) and 30 mg/kg/day treatment period (4 weeks).
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