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

Phase 3

Completed

• Conditions: Partial Epilepsy in Children and Adolescents
• Interventions: Drug: Eslicarbazepine acetate (BIA 2-093); Drug: Eslicarbazepine acetate

• Registration Number: NCT00988156
• Lead Sponsor: Bial - Portela C S.A.

Brief Summary

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

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 Timeline

• Study Start: 2007-12-07
• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Primary Completion: 2012-08-20
• Results First Submitted: 2014-05-09
• Results First Submitted QC: 2014-07-16
• Results First Posted: 2014-07-17
• Study Completion: 2017-08-24
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eslicarbazepine acetate	Eslicarbazepine acetate (BIA 2-093)	To receive Eslicarbazepine acetate in addition to concomitant therapy
Placebo	Eslicarbazepine acetate	To receive placebo in addition to concomitant therapy

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Seizure Frequency	Baseline up to Visit 7	Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
Responder Rate	baseline up to Visit 7	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.

Trial Locations

Locations (90)

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

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