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

Clinical hospital Osjek Pediatric clinic, neuropediatric department; 🇭🇷 Osijek, Croatia

Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche; 🇩🇪 Kehl-Kork, Germany

Familienpraxis Oggersheim; 🇩🇪 Ludwigshafen, Germany

A.O.U. di Cagliari Clinica di neurologia infantile; 🇮🇹 Cagliari, Italy

Dipartimento di Neuroscienze, Unità Operativa di Neurologia Ospedale Bambin Gesù; 🇮🇹 Rome, Italy

Azienda Ospedaliera Universitaria Senese Ospedale Santa Maria alle Scotte Dipartimento materno infantile Struttura Complessa di Pediatria; 🇮🇹 Siena, Italy

University Putra Malaysia/Hospital Serdang - Department of Paediatrics, Faculty of Medicine and Health Sciences; 🇲🇾 Selangor, Malaysia

IMSP Centrul National Stiintifico-Practic Medicina de Urgenta; 🇲🇩 Chishinau, Moldova, Republic of

Cebu Davao Doctors Hospital; 🇵🇭 Cebu City, Cebu, Philippines

Davao Doctor's Hospital; 🇵🇭 Davao City, Davao Del Sur, Philippines

Jose R. Reyes Memorial Medical Center - 5th Floor, Training and Research Office, Jose Reyes Memorial Hospital; 🇵🇭 Santa Cruz, Manila, Philippines

SAMODZIELNY PUBLICZNY SZPITAL KLINICZNY NR 6 ŚLĄSKIEJ AKADEMII MEDYCZNEJ W KATOWICACH GÓRNOŚLĄSKIE CENTRUM ZDROWIA DZIECKA I MATKI IM. JANA PAWŁA II Klinika Pediatrii i Neurologii Wieku Rozwojowego; 🇵🇱 Katowice, Poland

WOJEWÓDZKI SPECJALISTYCZNY SZPITAL DZIECIĘCY im. ŚW. LUDWIKA W KRAKOWIE; 🇵🇱 Kraków, Poland

AKADEMIA MEDYCZNA im. Karola Marcinkowskiego w Poznaniu Katedra I Klinika Neurologii Wieku Rozwojowego; 🇵🇱 Poznan, Poland

Przychodnia NEUROSPHERA; 🇵🇱 Warszawa, Poland

Hospital Dona Estefânia; 🇵🇹 Lisboa, Portugal

Hospital Francisco Xavier; 🇵🇹 Lisboa, Portugal

Hospital Geral de Santo António; 🇵🇹 Porto, Portugal

Clinica de Neurologie Peciatrica, Spitalul "Alexandru Obregia"; 🇷🇴 Bucharest, Romania

Spitalul Clinic de Urgenta pentru copii Luis Turcanu, Clinica de Psihiatrie si Neurologie pentru copii si adolescenti; 🇷🇴 Timisoara, Romania

Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1; 🇷🇺 Voronezh, Russian Federation

Child Neurology Service, Institute of Mother and Child Healthcare of Serbia "Dr. Vukan Cupic"; 🇷🇸 Belgrade, Serbia

Tempus, s.r.o.Child Epileptology Ambulance; 🇸🇰 Liptovský Mikuláš, Slovakia

Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology; 🇷🇺 Moscow, Russian Federation

Department of Neurolog, Regional Pediatric Clinical Hospital No. 1 Ekaterinburg; 🇷🇺 Ekaterinburg, Russian Federation

Pediatric Scientific-practical Center of cranio-facial surgery and neurology; 🇷🇺 Moscow, Russian Federation

Research Center of Children Health of RAMS; 🇷🇺 Moscow, Russian Federation

Clinic of Neurology and Psychiatry for Children and Youth; 🇷🇸 Belgrade, Serbia

Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology; 🇺🇦 Dnepropetrovsk, Ukraine

Hospital pediatrics of Odessa State Medical University Odessa; 🇺🇦 Odessa, Ukraine

Ospedale Petiatrico IRCCS; 🇮🇹 Genova, Italy

Clinical Centre Banja Luka Pediatric Clinic Department of Neurology; 🇧🇦 Banja Luka, Bosnia and Herzegovina

Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien; 🇦🇹 Vienna, Austria

Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department; 🇧🇦 Sarajevo, Bosnia and Herzegovina

Child Neurology Clinic of the DNsP Ostrava; 🇨🇿 Ostrava, Czechia

Pécsi Tudományegyetem AOK Gyermekklinika; 🇭🇺 Pécs, Hungary

Manila Doctors Hospital - Child Nueroscience Center; 🇵🇭 Ermita, Manila, Philippines

Children Neurology Dept., Institute of Child- and Adolescent Health Care of Vojvodina; 🇷🇸 Novi Sad, Serbia

Neurologická ambulancia; 🇸🇰 Hlohovec, Slovakia

Nizhny Novgorod State Medical Academy Pediatric City Clinical Hospital No. 1; 🇷🇺 Nizhny Novgorod, Russian Federation

Child Epileptology Out-patient; 🇸🇰 Dolny Kubin, Slovakia

IMAS Hospital del Mar - Servicio de Pediatria; 🇪🇸 Barcelona, Spain

Hospital Son Dureta, Dep. Neuropediatría; 🇪🇸 Palma de Mallorca, Spain

Birmingham Children's Hospital; 🇬🇧 Birmingham, United Kingdom

The Royal London Hospital; 🇬🇧 London, United Kingdom

Ukrainian Medical Rehabilitation Centre for Children with Organic Disorders of Nervous System; 🇺🇦 Kiev, Ukraine

St Georges Hospital, Child Development; 🇬🇧 London, United Kingdom

Great Ormond Street Hospital; 🇬🇧 London, United Kingdom

Clinic for Sick Children "Dr. Sabol"; 🇭🇷 Zagreb, Croatia

CHU Hopital Nord; 🇫🇷 Amiens, France

Budai Gyermekkórház, Buda Children's Hospital and Outpatient Clinic; 🇭🇺 Budapest, Hungary

Clinic for Children Diseases Zagreb; 🇭🇷 Zagreb, Croatia

Hopital Enfants de la Timone; 🇫🇷 Marseille, France

Neurology Policlinic; 🇨🇿 Hradec Králové, Czechia

Children Neurology Dept., Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház; 🇭🇺 Miskolc, Hungary

Hopital Pédiatrique Enfants; 🇫🇷 Bordeaux, France

Hopital des Enfants; 🇫🇷 Toulouse, France

Université Paris Descartes, Hopital Necker-Enfants Malades, Département de Neuropédiatrie; 🇫🇷 Paris, France

Clinic of the Child Neurology, FN Brno; 🇨🇿 Brno, Czechia

A. O. C. "Poma"; 🇮🇹 Mantova, Italy

Fondazione Istituto Neurologico Casimiro Mondino; 🇮🇹 Pavia, Italy

Servizio di Neuropsichiatria Infantile Policlinico "G.B. Rossi" Borgo Roma; 🇮🇹 Verona, Italy

Hospital Raja Perempuan Zainab II - Jabatan Paediatrik; 🇲🇾 Kelantan, Malaysia

Perpetual Succour Hospital - Neuroscience Center, 7/F SPC Medical Specialty Center; 🇵🇭 Cebu City, Cebu, Philippines

Instytut Neuromedica; 🇵🇱 Kraków, Poland

Krakowski Szpital, Specjalistyczny Im. Jana Pawła Ii W Krakowie; 🇵🇱 Krakow, Poland

Instytut "Centrum Zdrowia Matki Polki" Klinika Neurologii; 🇵🇱 Łódź, Poland

Hospital Pediátrico de Coimbra; 🇵🇹 Coimbra, Portugal

Hospital Santa Maria; 🇵🇹 Lisboa, Portugal

Hospital Pedro Hispano; 🇵🇹 Matosinhos, Portugal

Hospital Sant Joan de Déu, Dep. Neuropediatría; 🇪🇸 Esplugues de Llobregat, Spain

Hospital Maria Pia; 🇵🇹 Porto, Portugal

Clinical Hospital for children, Paediatric Neurology clinic; 🇷🇴 Cluj Napoca, Romania

Clinical Centre Nis, Clinic of Children Internal Diseases, Child Neurology Department; 🇷🇸 Nis, Serbia

National Taiwan University Hospital - Department of Paediatrics; 🇨🇳 Taipei City, Taiwan

Hospital Materno Infantil Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Vall Hebron; 🇪🇸 Barcelona, Spain

Hospital Son Dureta Dep. Neuropediatría; 🇪🇸 Palma de Mallorca, Spain

Taipei Veterans General Hospital - Department of Paediatrics; 🇨🇳 Taipei City, Taiwan

Institute of Neurology, Psychiatry and Narcology, AMS of Ukraine Acad.; 🇺🇦 Kharkiv, Ukraine

Hospital Clínico San Carlos, Servicio de Neurología Pediátrica; 🇪🇸 Madrid, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Crawley Hospital; 🇬🇧 Crawley, United Kingdom

Department of Paediatric, Clarendon Wing, Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

Queen's Hospital; 🇬🇧 Romford, United Kingdom

Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle upon Tyne, United Kingdom

Department of the Child Neurology FTN; 🇨🇿 Praha 4, Czechia

Children Neurology Clinic, University Hospital Motol; 🇨🇿 Praha 5, Czechia