children and adolescents with refractory partial epileptic seizures MedDRA version: 14.1 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
BIAL - Portela & Ca, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Children aged 2 to 18 years • Young girls of child bearing potential have to follow a reliable and medically acceptable contraceptive method during all duration of 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 AED except oxcarbazepine); if present, vagus 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 Are the trial subjects under 18? yes Number of subjects for this age range: 230 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Primarily generalised seizures • Baseline seizure frequency aubstantially different from usual aeizure frequency • Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive cerebral lesion) • Known second or third degree atrioventricular (AV) block • History of status epilepticus within the 3 months prior to enrolment • Seizures of non-epileptic origin (e.g. metabolic or neoplastic, or related to active infection) • Lennox-Gastaut syndrome • West syndrome • Major psychiatric disorders • Previous treatment in any study with Eslicarbazepine Acetate • Pregnancy • Breast-feeding • History of hypersensitiviti to the investigational products or to drugs with similar chemical structures • Impaired renal function, as shown by creatinine clearance values <60mL/min at screening • Any other clinically significant abnormal laboratory finding at screening • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol • Inadequate completion of the study diaries during the baseline period • Inadequate completation with study requirements during the baseline period • Participation in a clinical trial within the last 2 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of eslicarbazepine acetate as adjunctive therapy in children and adolescents with refractory partial seizures. The primary analysis variables for the assessment of efficacy will be: 1. the responder rate, defined as the proportion of patients with at least a 50% decrease in the standardised seizure frequency 2. the relative reduction in the standardised seizure frequency;Secondary Objective: The secondary objectives of the study are: • To assess the safety and tolerability of eslicarbazepine acetate as adjunctive therapy in children and adolescents with refractory partial seizures • To assess the proportion of seizure-free patients and of patients with more than 75% reduction in seizure frequency • To assess the frequency of patients with exacerbations • To assess the duration of seizures and severity of seizures (using the Hague seizure severity scale) • To assess the potential for rebound effects and withdrawal phenomena • To assess the potential for interactions between eslicarbazepine acetate and concomitant AED medication • To assess the seizure frequency by seizure type • To assess the maintenance of the therapeutic effect of eslicarbazepine acetate during long-term treatment in Part II of the study;Primary end point(s): Two primary variables with the following hierarchical order are defined: 1. Responder rate, defined as the proportion 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. 2. Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period. ;Timepoint(s) of evaluation of this end point: Part I: • Baseline period (8 weeks scheduled): between Visit V1 (screening visit) and first intake of double-blind study medication at Visit V2 • Titration period (6 weeks scheduled): between first intake of double-blind study medicati | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To assess the safety and tolerability of Eslicarbazepine Acetate as adjunctive therapy in children and adolescents with refractory partial seizures • To assess the proportion of seizure-free patients and of patients with more than 75% reduction in seizure frequency • To assess the frequency of patients with exacerbations • To assess the duration of seizures and severity of seizures (using the Hague seizure severity scale) • To assess the potential for rebound effects and withdrawal phenomena • To assess the potential for interactions between Eslicarbazepine Acetate and concomitant AED medication • To assess the seizure frequency by seizure type • To assess the maintenance of the therapeutic effect of Eslicarbazepine Acetate during long-term treatment in Part II of the study;Timepoint(s) of evaluation of this end point: Part I: • Baseline period (8 weeks scheduled): between Visit V1 (screening visit) and first intake of double-blind study medication at Visit V2 • Titration period (6 weeks scheduled): between first intake of double-blind study medication at Visit V2 and Visit V4 • Maintenance period (12 weeks scheduled): between intake of study medication at Visit V4 and Visit V7 • Tapering-off /follow-up period (4 8 weeks scheduled): between Visit V7 and Visit FU1 Part II: please refer to protocol and amendments. | — |
Countries
Austria, Bosnia and Herzegovina, Czech Republic, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Ukraine, United Kingdom
Contacts
Public ContactDep. of Research and Development
BIAL - Portela & Ca, S.A.
Outcome results
None listed