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

Primary Purpose

Partial Epilepsy in Children and Adolescents

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eslicarbazepine acetate (BIA 2-093)
Eslicarbazepine acetate
Sponsored by
Bial - Portela C S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Epilepsy in Children and Adolescents focused on measuring Epilepsy, Partial, Refractory, Children, Adolescents, Adjunctive, Randomised, Double-blind, Placebo-controlled, Parallel-group

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz
  • Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien
  • Clinical Centre Banja Luka Pediatric Clinic Department of Neurology
  • Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department
  • Clinical hospital Osjek Pediatric clinic, neuropediatric department
  • Clinic for Children Diseases Zagreb
  • Clinic for Sick Children "Dr. Sabol"
  • Clinic of the Child Neurology, FN Brno
  • Neurology Policlinic
  • Child Neurology Clinic of the DNsP Ostrava
  • Department of the Child Neurology FTN
  • Children Neurology Clinic, University Hospital Motol
  • CHU Hopital Nord
  • Hopital Pédiatrique Enfants
  • Hopital Enfants de la Timone
  • Université Paris Descartes, Hopital Necker-Enfants Malades, Département de Neuropédiatrie
  • Hopital des Enfants
  • Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche
  • Familienpraxis Oggersheim
  • Budai Gyermekkórház, Buda Children's Hospital and Outpatient Clinic
  • Children Neurology Dept., Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
  • Pécsi Tudományegyetem AOK Gyermekklinika
  • A.O.U. di Cagliari Clinica di neurologia infantile
  • Ospedale Petiatrico IRCCS
  • A. O. C. "Poma"
  • Fondazione Istituto Neurologico Casimiro Mondino
  • Dipartimento di Neuroscienze, Unità Operativa di Neurologia Ospedale Bambin Gesù
  • Azienda Ospedaliera Universitaria Senese Ospedale Santa Maria alle Scotte Dipartimento materno infantile Struttura Complessa di Pediatria
  • Servizio di Neuropsichiatria Infantile Policlinico "G.B. Rossi" Borgo Roma
  • Hospital Raja Perempuan Zainab II - Jabatan Paediatrik
  • University Putra Malaysia/Hospital Serdang - Department of Paediatrics, Faculty of Medicine and Health Sciences
  • IMSP Centrul National Stiintifico-Practic Medicina de Urgenta
  • Cebu Davao Doctors Hospital
  • Perpetual Succour Hospital - Neuroscience Center, 7/F SPC Medical Specialty Center
  • Davao Doctor's Hospital
  • Manila Doctors Hospital - Child Nueroscience Center
  • Jose R. Reyes Memorial Medical Center - 5th Floor, Training and Research Office, Jose Reyes Memorial Hospital
  • 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
  • Krakowski Szpital, Specjalistyczny Im. Jana Pawła Ii W Krakowie
  • Instytut Neuromedica
  • WOJEWÓDZKI SPECJALISTYCZNY SZPITAL DZIECIĘCY im. ŚW. LUDWIKA W KRAKOWIE
  • AKADEMIA MEDYCZNA im. Karola Marcinkowskiego w Poznaniu Katedra I Klinika Neurologii Wieku Rozwojowego
  • Przychodnia NEUROSPHERA
  • Instytut "Centrum Zdrowia Matki Polki" Klinika Neurologii
  • Hospital Pediátrico de Coimbra
  • Hospital Dona Estefânia
  • Hospital Francisco Xavier
  • Hospital Santa Maria
  • Hospital Pedro Hispano
  • Hospital Geral de Santo António
  • Hospital Maria Pia
  • Clinica de Neurologie Peciatrica, Spitalul "Alexandru Obregia"
  • Clinical Hospital for children, Paediatric Neurology clinic
  • Spitalul Clinic de Urgenta pentru copii Luis Turcanu, Clinica de Psihiatrie si Neurologie pentru copii si adolescenti
  • Department of Neurolog, Regional Pediatric Clinical Hospital No. 1 Ekaterinburg
  • Pediatric Scientific-practical Center of cranio-facial surgery and neurology
  • Research Center of Children Health of RAMS
  • Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology
  • Nizhny Novgorod State Medical Academy Pediatric City Clinical Hospital No. 1
  • Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1
  • Child Neurology Service, Institute of Mother and Child Healthcare of Serbia "Dr. Vukan Cupic"
  • Clinic of Neurology and Psychiatry for Children and Youth
  • Clinical Centre Nis, Clinic of Children Internal Diseases, Child Neurology Department
  • Children Neurology Dept., Institute of Child- and Adolescent Health Care of Vojvodina
  • Child Epileptology Out-patient
  • Neurologická ambulancia
  • Neurologická ambulancia
  • Tempus, s.r.o.Child Epileptology Ambulance
  • IMAS Hospital del Mar - Servicio de Pediatria
  • Hospital Vall Hebron
  • Hospital Sant Joan de Déu, Dep. Neuropediatría
  • Hospital Materno Infantil Virgen de las Nieves
  • Hospital Clínico San Carlos, Servicio de Neurología Pediátrica
  • Hospital Son Dureta Dep. Neuropediatría
  • Hospital Son Dureta, Dep. Neuropediatría
  • Hospital Universitario Miguel Servet
  • National Taiwan University Hospital - Department of Paediatrics
  • Taipei Veterans General Hospital - Department of Paediatrics
  • Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology
  • Institute of Neurology, Psychiatry and Narcology, AMS of Ukraine Acad.
  • Ukrainian Medical Rehabilitation Centre for Children with Organic Disorders of Nervous System
  • Hospital pediatrics of Odessa State Medical University Odessa
  • Birmingham Children's Hospital
  • Crawley Hospital
  • Department of Paediatric, Clarendon Wing, Leeds General Infirmary
  • The Royal London Hospital
  • St Georges Hospital, Child Development
  • Great Ormond Street Hospital
  • Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Queen's Hospital
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Eslicarbazepine acetate

Placebo

Arm Description

To receive Eslicarbazepine acetate in addition to concomitant therapy

To receive placebo in addition to concomitant therapy

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 1, 2009
Last Updated
October 12, 2018
Sponsor
Bial - Portela C S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00988156
Brief Title
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
Official Title
Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 7, 2007 (Actual)
Primary Completion Date
August 20, 2012 (Actual)
Study Completion Date
August 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsy in Children and Adolescents
Keywords
Epilepsy, Partial, Refractory, Children, Adolescents, Adjunctive, Randomised, Double-blind, Placebo-controlled, Parallel-group

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eslicarbazepine acetate
Arm Type
Active Comparator
Arm Description
To receive Eslicarbazepine acetate in addition to concomitant therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
To receive placebo in addition to concomitant therapy
Intervention Type
Drug
Intervention Name(s)
Eslicarbazepine acetate (BIA 2-093)
Other Intervention Name(s)
BIA 2093
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Eslicarbazepine acetate
Other Intervention Name(s)
BIA 2093
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Seizure Frequency
Description
Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
Time Frame
Baseline up to Visit 7
Title
Responder Rate
Description
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.
Time Frame
baseline up to Visit 7

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
31878820
Citation
Mintz M, Pina-Garza JE, Wolf SM, McGoldrick PE, Jozwiak S, Grinnell T, Cantu D, Costa R, Moreira J, Li Y, Blum D. Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures. J Child Neurol. 2020 Mar;35(4):265-273. doi: 10.1177/0883073819890997. Epub 2019 Dec 26.
Results Reference
derived
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-001887-55/results
Description
EU Clinical Trials Register: Clinical Trial Results

Learn more about this trial

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

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