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

PHASE3CompletedINTERVENTIONAL
Enrollment

304

Participants

Timeline

Start Date

December 7, 2007

Primary Completion Date

August 20, 2012

Study Completion Date

August 24, 2017

Conditions
Partial Epilepsy in Children and Adolescents
Interventions
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."

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."

Trial Locations (91)

100

National Taiwan University Hospital - Department of Paediatrics, Taipei

112

Taipei Veterans General Hospital - Department of Paediatrics, Taipei

1000

Manila Doctors Hospital - Child Nueroscience Center, Ermita

1003

Jose R. Reyes Memorial Medical Center - 5th Floor, Training and Research Office, Jose Reyes Memorial Hospital, Santa Cruz

1023

Budai Gyermekkórház, Buda Children's Hospital and Outpatient Clinic, Budapest

1090

Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien, Vienna

2004

IMSP Centrul National Stiintifico-Practic Medicina de Urgenta, Chishinau

3526

Children Neurology Dept., Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Miskolc

6000

Cebu Davao Doctors Hospital, Cebu City

Perpetual Succour Hospital - Neuroscience Center, 7/F SPC Medical Specialty Center, Cebu City

7623

Pécsi Tudományegyetem AOK Gyermekklinika, Pécs

8000

Davao Doctor's Hospital, Davao City

8035

Hospital Vall Hebron, Barcelona

8036

Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz, Graz

8950

Hospital Sant Joan de Déu, Dep. Neuropediatría, Esplugues de Llobregat

11000

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

Clinic of Neurology and Psychiatry for Children and Youth, Belgrade

15586

Hospital Raja Perempuan Zainab II - Jabatan Paediatrik, Kelantan

16147

Ospedale Petiatrico IRCCS, Genova

18000

Clinical Centre Nis, Clinic of Children Internal Diseases, Child Neurology Department, Niš

18012

Hospital Materno Infantil Virgen de las Nieves, Granada

21000

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

27100

Fondazione Istituto Neurologico Casimiro Mondino, Pavia

28040

Hospital Clínico San Carlos, Servicio de Neurología Pediátrica, Madrid

33000

Hopital Pédiatrique Enfants, Bordeaux

37126

"Servizio di Neuropsichiatria Infantile Policlinico G.B. Rossi Borgo Roma", Verona

43400

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

46100

"A. O. C. Poma", Mantova

49027

Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology, Dnipro

50009

Hospital Universitario Miguel Servet, Zaragoza

53100

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

61068

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

65031

Hospital pediatrics of Odessa State Medical University Odessa, Odesa

67071

Familienpraxis Oggersheim, Ludwigshafen

71000

Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department, Sarajevo

75015

Université Paris Descartes, Hopital Necker-Enfants Malades, Département de Neuropédiatrie, Paris

77694

Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche, Kehl-Kork

78000

Clinical Centre Banja Luka Pediatric Clinic Department of Neurology, Banja Luka

92001

Neurologická ambulancia, Hlohovec

119620

Pediatric Scientific-practical Center of cranio-facial surgery and neurology, Moscow

119991

Research Center of Children Health of RAMS, Moscow

127412

Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology, Moscow

300011

Spitalul Clinic de Urgenta pentru copii Luis Turcanu, Clinica de Psihiatrie si Neurologie pentru copii si adolescenti, Timișoara

394024

Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1, Voronezh

400084

Clinical Hospital for children, Paediatric Neurology clinic, Cluj-Napoca

603081

Nizhny Novgorod State Medical Academy Pediatric City Clinical Hospital No. 1, Nizhny Novgorod

620149

Department of Neurolog, Regional Pediatric Clinical Hospital No. 1 Ekaterinburg, Yekaterinburg

31 000

Clinical hospital Osjek Pediatric clinic, neuropediatric department, Osijek

10 000

Clinic for Children Diseases Zagreb, Zagreb

"Clinic for Sick Children Dr. Sabol", Zagreb

613 00

Clinic of the Child Neurology, FN Brno, Brno

500 03

Neurology Policlinic, Hradec Králové

708 52

Child Neurology Clinic of the DNsP Ostrava, Ostrava

140 59

Department of the Child Neurology FTN, Prague

150 00

Children Neurology Clinic, University Hospital Motol, Prague

80054 Cedex

CHU Hopital Nord, Amiens

13385 Cedex 5

Hopital Enfants de la Timone, Marseille

31026 Cedex

Hopital des Enfants, Toulouse

09124

A.O.U. di Cagliari Clinica di neurologia infantile, Cagliari

00165

Dipartimento di Neuroscienze, Unità Operativa di Neurologia Ospedale Bambin Gesù, Rome

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, Katowice

30-418

Instytut Neuromedica, Krakow

31-202

Krakowski Szpital, Specjalistyczny Im. Jana Pawła Ii W Krakowie, Krakow

31-503

WOJEWÓDZKI SPECJALISTYCZNY SZPITAL DZIECIĘCY im. ŚW. LUDWIKA W KRAKOWIE, Krakow

93-338

"Instytut Centrum Zdrowia Matki Polki Klinika Neurologii", Lodz

60-355

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

02-942

Przychodnia NEUROSPHERA, Warsaw

3000-076

Hospital Pediátrico de Coimbra, Coimbra

1169-045

Hospital Dona Estefânia, Lisbon

1495-005

Hospital Francisco Xavier, Lisbon

1649-035

Hospital Santa Maria, Lisbon

4454-509

Hospital Pedro Hispano, Matosinhos Municipality

4050-060

Hospital Geral de Santo António, Porto

4050-111

Hospital Maria Pia, Porto

041914

"Clinica de Neurologie Peciatrica, Spitalul Alexandru Obregia", Bucharest

026 01

Child Epileptology Out-patient, Dolný Kubín

018 41

Neurologická ambulancia, Dubnica nad Váhom

031 04

Tempus, s.r.o.Child Epileptology Ambulance, Liptovský Mikuláš

08003

IMAS Hospital del Mar - Servicio de Pediatria, Barcelona

07014

Hospital Son Dureta Dep. Neuropediatría, Palma de Mallorca

Unknown

Hospital Son Dureta, Dep. Neuropediatría, Palma de Mallorca

04209

Ukrainian Medical Rehabilitation Centre for Children with Organic Disorders of Nervous System, Kiev

B4 6NH

Birmingham Children's Hospital, Birmingham

RH11 7DH

Crawley Hospital, Crawley

LS2 9NS

Department of Paediatric, Clarendon Wing, Leeds General Infirmary, Leeds

E1 1BB

The Royal London Hospital, London

SW17 OQT

St Georges Hospital, Child Development, London

WC1N 3JH

Great Ormond Street Hospital, London

NE1 4LP

Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

RM7 0AG

Queen's Hospital, Romford

SO16 6YD

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Bial - Portela C S.A.

INDUSTRY

NCT00988156 - Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children | Biotech Hunter | Biotech Hunter