Pharmacokinetics, Efficacy and Tolerability of BIA 2-093
Pharmacokinetics, Efficacy and Tolerability of BIA 2-093
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.
Inclusion Criteria:

 The following inclusion criteria were applied in selecting patients for participation in
 the trial.

 Patient was eligible for entry into the baseline phase if he/she fulfilled the following
 criteria at Visit 1:

 -  Written informed consent given by the parent(s)/guardian(s), and by the patient when
 appropriate.

 -  Male or female patient aged between 2 and 17 years.

 -  Body weight within the 10th and 90th percentiles, by age and sex.

 -  A documented diagnosis of partial-onset seizures (simple or complex seizures with or
 without secondary generalisation), classified according to the International
 Classification of Epileptic Seizures.

 -  Currently treated with 1 to 3 AEDs (any except OXC or CBZ), in a stable dosage regimen
 during at least 1 month prior to screening.

 -  Good general health (apart from epilepsy) based on medical history and physical
 examination.

 -  In case of a female patient, she was premenarchal, surgically sterile or presented a
 urine pregnancy test consistent with a non-gravid state and practiced an effective
 non-hormonal contraception method.

 At Visit 2, patient was eligible for entry into the Eslicarbazepine acetate treatment phase
 if he/she fulfilled the following criteria:

 -  At least 4 partial-onset seizures during the last 4 weeks of the baseline phase.

 -  Brain CT scan or MRI that excluded rapidly progressive neurological diseases.

 -  ECG without clinically significant abnormalities.

 -  Good general health (apart from epilepsy) based on medical history, physical
 examination and laboratory tests at screening.

 -  Diaries satisfactorily completed by the patient or his/her caregiver during the
 baseline phase.

 -  Satisfactory compliance with the study requirements during the baseline phase.

 -  In case of a female patient of childbearing potential, she presented a urine pregnancy
 test consistent with a non-gravid state and practiced an effective non-hormonal
 contraception method.

 Exclusion Criteria:

 Patient was not allowed for entry into the screening phase if he/she fulfilled the
 following criteria at Visit 1:

 -  Primarily generalised epilepsy.

 -  Clinically relevant medical condition, other than epilepsy.

 -  History of status epilepticus in the last 3 months.

 -  History of suicide attempt.

 -  History of alcohol or drug abuse.

 -  History of hypersensitivity or intolerance to OXC or CBZ.

 -  Use of any investigational drug or participated in any clinical trial within the
 previous 2 months.

 -  Patient and/or his/her caregiver(s) unlikely to co-operate with the requirements of
 the study.

 -  If female, she was sexually active and of child-bearing potential and she did not use
 reliable contraception.

 -  Patients with non-epileptic attacks (syncopes, pseudoseizures).

 -  Previous poor compliance with anti-epileptic therapy.

 -  Need for rescue benzodiazepines more frequently than twice per week on average.

 -  Previous use of Eslicarbazepine acetate or participation in a clinical study with
 Eslicarbazepine acetate.

 -  Any other condition or circumstance that, in the opinion of the investigator, might
 compromise the patient's ability to comply with the clinical trial protocol (CTP).

 At Visit 2, patient was not eligible for entry into the Eslicarbazepine acetate treatment
 phase if he/she fulfilled the following criteria:

 -  Inadequate compliance to concomitant AEDs during the baseline phase.

 -  Clinically relevant clinical laboratory test abnormalities at screening.

 -  Occurrence of any other condition or circumstance that, in the opinion of the
 investigator, might compromise the patient's ability to comply with the CTP.