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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00988156
First received: October 1, 2009
Last updated: July 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Partial Epilepsy in Children and Adolescents
Drug: Eslicarbazepine acetate (BIA 2-093)
Drug: Eslicarbazepine acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • Change From Baseline in Seizure Frequency [ Time Frame: Baseline up to Visit 7 ] [ Designated as safety issue: No ]
    Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.

  • Responder Rate [ Time Frame: baseline up to Visit 7 ] [ Designated as safety issue: No ]
    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.


Enrollment: 304
Study Start Date: December 2007
Estimated Study Completion Date: October 2015
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: BIA 2093

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
  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988156

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

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00988156     History of Changes
Other Study ID Numbers: BIA-2093-305
Study First Received: October 1, 2009
Results First Received: May 9, 2014
Last Updated: July 16, 2014
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by Bial - Portela C S.A.:
Epilepsy
Partial
Refractory
Children
Adolescents
Adjunctive
Randomised
Double-blind
Placebo-controlled
Parallel-group

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014