Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children

Conditions
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Partial Epilepsy in Children and Adolescents

Intervention / Treatment
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* Drug: Eslicarbazepine acetate (BIA 2-093)
* Drug: Eslicarbazepine acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eslicarbazepine acetate<br>To receive Eslicarbazepine acetate in addition to concomitant therapy | Drug: Eslicarbazepine acetate (BIA 2-093)<br>* 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.<br>* Other names: BIA 2093;|
| Placebo Comparator: Placebo<br>To receive placebo in addition to concomitant therapy | Drug: Eslicarbazepine acetate<br>* 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.<br>* Other names: BIA 2093;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | baseline up to Visit 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Partial, Refractory, Children, Adolescents, Adjunctive, Randomised, Double-blind, Placebo-controlled, Parallel-group