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

October 12, 2018 updated by: Bial - Portela C S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

304

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz
      • Vienna, Austria, 1090
        • Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina, 78000
        • Clinical Centre Banja Luka Pediatric Clinic Department of Neurology
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department
  • Croatia
      • Osijek, Croatia, 31 000
        • Clinical hospital Osjek Pediatric clinic, neuropediatric department
      • Zagreb, Croatia, 10 000
        • Clinic for Children Diseases Zagreb
      • Zagreb, Croatia, 10 000
        • Clinic for Sick Children "Dr. Sabol"
  • Czechia
      • Brno, Czechia, 613 00
        • Clinic of the Child Neurology, FN Brno
      • Hradec Králové, Czechia, 500 03
        • Neurology Policlinic
      • Ostrava, Czechia, 708 52
        • Child Neurology Clinic of the DNsP Ostrava
      • Praha 4, Czechia, 140 59
        • Department of the Child Neurology FTN
      • Praha 5, Czechia, 150 00
        • Children Neurology Clinic, University Hospital Motol
  • France
      • Amiens, France, 80054 Cedex
        • CHU Hopital Nord
      • Bordeaux, France, 33000
        • Hopital Pédiatrique Enfants
      • Marseille, France, 13385 Cedex 5
        • Hopital Enfants de la Timone
      • Paris, France, 75015
        • Université Paris Descartes, Hopital Necker-Enfants Malades, Département de Neuropédiatrie
      • Toulouse, France, 31026 Cedex
        • Hopital des Enfants
  • Germany
      • Kehl-Kork, Germany, 77694
        • Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche
      • Ludwigshafen, Germany, 67071
        • Familienpraxis Oggersheim
  • Hungary
      • Budapest, Hungary, 1023
        • Budai Gyermekkórház, Buda Children's Hospital and Outpatient Clinic
      • Miskolc, Hungary, 3526
        • Children Neurology Dept., Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
      • Pécs, Hungary, 7623
        • Pécsi Tudományegyetem AOK Gyermekklinika
  • Italy
      • Cagliari, Italy, 09124
        • A.O.U. di Cagliari Clinica di neurologia infantile
      • Genova, Italy, 16147
        • Ospedale Petiatrico IRCCS
      • Mantova, Italy, 46100
        • A. O. C. "Poma"
      • Pavia, Italy, 27100
        • Fondazione Istituto Neurologico Casimiro Mondino
      • Rome, Italy, 00165
        • Dipartimento di Neuroscienze, Unità Operativa di Neurologia Ospedale Bambin Gesù
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese Ospedale Santa Maria alle Scotte Dipartimento materno infantile Struttura Complessa di Pediatria
      • Verona, Italy, 37126
        • Servizio di Neuropsichiatria Infantile Policlinico "G.B. Rossi" Borgo Roma
  • Malaysia
      • Kelantan, Malaysia, 15586
        • Hospital Raja Perempuan Zainab II - Jabatan Paediatrik
      • Selangor, Malaysia, 43400
        • University Putra Malaysia/Hospital Serdang - Department of Paediatrics, Faculty of Medicine and Health Sciences
  • Moldova, Republic of
      • Chishinau, Moldova, Republic of, 2004
        • IMSP Centrul National Stiintifico-Practic Medicina de Urgenta
  • Philippines
    • Cebu
      • Cebu City, Cebu, Philippines, 6000
        • Cebu Davao Doctors Hospital
      • Cebu City, Cebu, Philippines, 6000
        • Perpetual Succour Hospital - Neuroscience Center, 7/F SPC Medical Specialty Center
    • Davao Del Sur
      • Davao City, Davao Del Sur, Philippines, 8000
        • Davao Doctor's Hospital
    • Manila
      • Ermita, Manila, Philippines, 1000
        • Manila Doctors Hospital - Child Nueroscience Center
      • Santa Cruz, Manila, Philippines, 1003
        • Jose R. Reyes Memorial Medical Center - 5th Floor, Training and Research Office, Jose Reyes Memorial Hospital
  • Poland
      • Katowice, Poland, 40-752
        • 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
      • Krakow, Poland, 31-202
        • Krakowski Szpital, Specjalistyczny Im. Jana Pawła Ii W Krakowie
      • Kraków, Poland, 30-418
        • Instytut Neuromedica
      • Kraków, Poland, 31-503
        • Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
      • Poznan, Poland, 60-355
        • AKADEMIA MEDYCZNA im. Karola Marcinkowskiego w Poznaniu Katedra I Klinika Neurologii Wieku Rozwojowego
      • Warszawa, Poland, 02-942
        • Przychodnia NEUROSPHERA
      • Łódź, Poland, 93-338
        • Instytut "Centrum Zdrowia Matki Polki" Klinika Neurologii
  • Portugal
      • Coimbra, Portugal, 3000-076
        • Hospital Pediátrico de Coimbra
      • Lisboa, Portugal, 1169-045
        • Hospital Dona Estefânia
      • Lisboa, Portugal, 1495-005
        • Hospital Francisco Xavier
      • Lisboa, Portugal, 1649-035
        • Hospital Santa Maria
      • Matosinhos, Portugal, 4454-509
        • Hospital Pedro Hispano
      • Porto, Portugal, 4050-060
        • Hospital Geral de Santo Antonio
      • Porto, Portugal, 4050-111
        • Hospital Maria Pia
  • Romania
      • Bucharest, Romania, 041914
        • Clinica de Neurologie Peciatrica, Spitalul "Alexandru Obregia"
      • Cluj Napoca, Romania, 400084
        • Clinical Hospital for children, Paediatric Neurology clinic
      • Timisoara, Romania, 300011
        • Spitalul Clinic de Urgenta pentru copii Luis Turcanu, Clinica de Psihiatrie si Neurologie pentru copii si adolescenti
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620149
        • Department of Neurolog, Regional Pediatric Clinical Hospital No. 1 Ekaterinburg
      • Moscow, Russian Federation, 119620
        • Pediatric Scientific-practical Center of cranio-facial surgery and neurology
      • Moscow, Russian Federation, 119991
        • Research Center of Children Health of RAMS
      • Moscow, Russian Federation, 127412
        • Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology
      • Nizhny Novgorod, Russian Federation, 603081
        • Nizhny Novgorod State Medical Academy Pediatric City Clinical Hospital No. 1
      • Voronezh, Russian Federation, 394024
        • Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinic of Neurology and Psychiatry for Children and Youth
      • Belgrade, Serbia, 11000
        • Child Neurology Service, Institute of Mother and Child Healthcare of Serbia "Dr. Vukan Cupic"
      • Nis, Serbia, 18000
        • Clinical Centre Nis, Clinic of Children Internal Diseases, Child Neurology Department
      • Novi Sad, Serbia, 21000
        • Children Neurology Dept., Institute of Child- and Adolescent Health Care of Vojvodina
  • Slovakia
      • Dolny Kubin, Slovakia, 026 01
        • Child Epileptology Out-patient
      • Dubnica nad Váhom, Slovakia, 018 41
        • Neurologická ambulancia
      • Hlohovec, Slovakia, 92001
        • Neurologická ambulancia
      • Liptovský Mikuláš, Slovakia, 031 04
        • Tempus, s.r.o.Child Epileptology Ambulance
  • Spain
      • Barcelona, Spain, 08003
        • IMAS Hospital del Mar - Servicio de Pediatria
      • Barcelona, Spain, 8035
        • Hospital Vall Hebron
      • Esplugues de Llobregat, Spain, 8950
        • Hospital Sant Joan de Déu, Dep. Neuropediatría
      • Granada, Spain, 18012
        • Hospital Materno Infantil Virgen de las Nieves
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos, Servicio de Neurología Pediátrica
      • Palma de Mallorca, Spain, 07014
        • Hospital Son Dureta Dep. Neuropediatría
      • Palma de Mallorca, Spain
        • Hospital Son Dureta, Dep. Neuropediatría
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • Taiwan
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital - Department of Paediatrics
      • Taipei City, Taiwan, 112
        • Taipei Veterans General Hospital - Department of Paediatrics
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49027
        • Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology
      • Kharkiv, Ukraine, 61068
        • Institute of Neurology, Psychiatry and Narcology, AMS of Ukraine Acad.
      • Kiev, Ukraine, 04209
        • Ukrainian Medical Rehabilitation Centre for Children with Organic Disorders of Nervous System
      • Odessa, Ukraine, 65031
        • Hospital pediatrics of Odessa State Medical University Odessa
  • United Kingdom
      • Birmingham, United Kingdom, B4 6NH
        • Birmingham Children's Hospital
      • Crawley, United Kingdom, RH11 7DH
        • Crawley Hospital
      • Leeds, United Kingdom, LS2 9NS
        • Department of Paediatric, Clarendon Wing, Leeds General Infirmary
      • London, United Kingdom, WC1N 3JH
        • Great Ormond Street Hospital
      • London, United Kingdom, E1 1BB
        • The Royal London Hospital
      • London, United Kingdom, SW17 OQT
        • St Georges Hospital, Child Development
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust
      • Romford, United Kingdom, RM7 0AG
        • Queen's Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Eslicarbazepine acetate
To receive Eslicarbazepine acetate in addition to concomitant therapy
Drug: Eslicarbazepine acetate (BIA 2-093)

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.

Other Names:
  • BIA 2093
Placebo Comparator: Placebo
To receive placebo in addition to concomitant therapy
Drug: Eslicarbazepine acetate

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.

Other Names:
  • BIA 2093

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Seizure Frequency
Time Frame: Baseline up to Visit 7
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
Time Frame: 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.
baseline up to Visit 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bial - Portela C S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2007

Primary Completion (Actual)

August 20, 2012

Study Completion (Actual)

August 24, 2017

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (Estimate)

October 2, 2009

Study Record Updates

Last Update Posted (Actual)

November 13, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIA-2093-305
  • 2007-001887-55 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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