Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures.
Mark Mintz, Jesus E Pina-Garza, Steven M Wolf...
https://pubmed.ncbi.nlm.nih.gov/31878820Completed
Phase 3
Age: 2Years - 16Years
All Genders
ID00988156
Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children
Led by Bial - Portela C S.A. · Updated on 2018-11-13
304
Participants Needed
91
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
Who Can Participate
Age: 2Years - 16Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
Trial Site Locations
Total: 91 locations
1
Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz
Graz, Austria, 8036
Status Unknown
2
Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien
Vienna, Austria, 1090
Status Unknown
3
Clinical Centre Banja Luka Pediatric Clinic Department of Neurology
Banja Luka, Bosnia and Herzegovina, 78000
Status Unknown
4
Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department
Sarajevo, Bosnia and Herzegovina, 71000
Status Unknown
5
Clinical hospital Osjek Pediatric clinic, neuropediatric department
Osijek, Croatia, 31 000
Status Unknown
6
Clinic for Children Diseases Zagreb
Zagreb, Croatia, 10 000
Status Unknown
7
Clinic for Sick Children "Dr. Sabol"
Zagreb, Croatia, 10 000
Status Unknown
8
Clinic of the Child Neurology, FN Brno
Brno, Czechia, 613 00
Status Unknown
9
Neurology Policlinic
Hradec Králové, Czechia, 500 03
Status Unknown
10
Child Neurology Clinic of the DNsP Ostrava
Ostrava, Czechia, 708 52
Status Unknown
11
Department of the Child Neurology FTN
Prague, Czechia, 140 59
Status Unknown
12
Children Neurology Clinic, University Hospital Motol
Prague, Czechia, 150 00
Status Unknown
13
CHU Hopital Nord
Amiens, France, 80054 Cedex
Status Unknown
14
Hopital Pédiatrique Enfants
Bordeaux, France, 33000
Status Unknown
15
Hopital Enfants de la Timone
Marseille, France, 13385 Cedex 5
Status Unknown
16
Université Paris Descartes, Hopital Necker-Enfants Malades, Département de Neuropédiatrie
Paris, France, 75015
Status Unknown
17
Hopital des Enfants
Toulouse, France, 31026 Cedex
Status Unknown
18
Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche
Kehl-Kork, Germany, 77694
Status Unknown
19
Familienpraxis Oggersheim
Ludwigshafen, Germany, 67071
Status Unknown
20
Budai Gyermekkórház, Buda Children's Hospital and Outpatient Clinic
Budapest, Hungary, 1023
Status Unknown
21
Children Neurology Dept., Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, Hungary, 3526
Status Unknown
22
Pécsi Tudományegyetem AOK Gyermekklinika
Pécs, Hungary, 7623
Status Unknown
23
A.O.U. di Cagliari Clinica di neurologia infantile
Cagliari, Italy, 09124
Status Unknown
24
Ospedale Petiatrico IRCCS
Genova, Italy, 16147
Status Unknown
25
A. O. C. "Poma"
Mantua, Italy, 46100
Status Unknown
26
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, Italy, 27100
Status Unknown
27
Dipartimento di Neuroscienze, Unità Operativa di Neurologia Ospedale Bambin Gesù
Rome, Italy, 00165
Status Unknown
28
Azienda Ospedaliera Universitaria Senese Ospedale Santa Maria alle Scotte Dipartimento materno infantile Struttura Complessa di Pediatria
Siena, Italy, 53100
Status Unknown
29
Servizio di Neuropsichiatria Infantile Policlinico "G.B. Rossi" Borgo Roma
Verona, Italy, 37126
Status Unknown
30
Hospital Raja Perempuan Zainab II - Jabatan Paediatrik
Kelantan, Kelantan, Malaysia, 15586
Status Unknown
31
University Putra Malaysia/Hospital Serdang - Department of Paediatrics, Faculty of Medicine and Health Sciences
Kuala Selangor, Selangor, Malaysia, 43400
Status Unknown
32
IMSP Centrul National Stiintifico-Practic Medicina de Urgenta
Chishinau, Moldova, 2004
Status Unknown
33
Cebu Davao Doctors Hospital
Cebu City, Cebu, Philippines, 6000
Status Unknown
34
Perpetual Succour Hospital - Neuroscience Center, 7/F SPC Medical Specialty Center
Cebu City, Cebu, Philippines, 6000
Status Unknown
35
Davao Doctor's Hospital
Davao City, Davao Del Sur, Philippines, 8000
Status Unknown
36
Manila Doctors Hospital - Child Nueroscience Center
Ermita, Manila, Philippines, 1000
Status Unknown
37
Jose R. Reyes Memorial Medical Center - 5th Floor, Training and Research Office, Jose Reyes Memorial Hospital
Santa Cruz, Manila, Philippines, 1003
Status Unknown
38
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
Status Unknown
39
Instytut Neuromedica
Krakow, Poland, 30-418
Status Unknown
40
Krakowski Szpital, Specjalistyczny Im. Jana Pawła Ii W Krakowie
Krakow, Poland, 31-202
Status Unknown
41
WOJEWÓDZKI SPECJALISTYCZNY SZPITAL DZIECIĘCY im. ŚW. LUDWIKA W KRAKOWIE
Krakow, Poland, 31-503
Status Unknown
42
Instytut "Centrum Zdrowia Matki Polki" Klinika Neurologii
Lodz, Poland, 93-338
Status Unknown
43
AKADEMIA MEDYCZNA im. Karola Marcinkowskiego w Poznaniu Katedra I Klinika Neurologii Wieku Rozwojowego
Poznan, Poland, 60-355
Status Unknown
44
Przychodnia NEUROSPHERA
Warsaw, Poland, 02-942
Status Unknown
45
Hospital Pediátrico de Coimbra
Coimbra, Portugal, 3000-076
Status Unknown
46
Hospital Dona Estefânia
Lisbon, Portugal, 1169-045
Status Unknown
47
Hospital Francisco Xavier
Lisbon, Portugal, 1495-005
Status Unknown
48
Hospital Santa Maria
Lisbon, Portugal, 1649-035
Status Unknown
49
Hospital Pedro Hispano
Matosinhos Municipality, Portugal, 4454-509
Status Unknown
50
Hospital Geral de Santo António
Porto, Portugal, 4050-060
Status Unknown
51
Hospital Maria Pia
Porto, Portugal, 4050-111
Status Unknown
52
Clinica de Neurologie Peciatrica, Spitalul "Alexandru Obregia"
Bucharest, Romania, 041914
Status Unknown
53
Clinical Hospital for children, Paediatric Neurology clinic
Cluj-Napoca, Romania, 400084
Status Unknown
54
Spitalul Clinic de Urgenta pentru copii Luis Turcanu, Clinica de Psihiatrie si Neurologie pentru copii si adolescenti
Timișoara, Romania, 300011
Status Unknown
55
Pediatric Scientific-practical Center of cranio-facial surgery and neurology
Moscow, Russia, 119620
Status Unknown
56
Research Center of Children Health of RAMS
Moscow, Russia, 119991
Status Unknown
57
Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology
Moscow, Russia, 127412
Status Unknown
58
Nizhny Novgorod State Medical Academy Pediatric City Clinical Hospital No. 1
Nizhny Novgorod, Russia, 603081
Status Unknown
59
Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1
Voronezh, Russia, 394024
Status Unknown
60
Department of Neurolog, Regional Pediatric Clinical Hospital No. 1 Ekaterinburg
Yekaterinburg, Russia, 620149
Status Unknown
61
Child Neurology Service, Institute of Mother and Child Healthcare of Serbia "Dr. Vukan Cupic"
Belgrade, Serbia, 11000
Status Unknown
62
Clinic of Neurology and Psychiatry for Children and Youth
Belgrade, Serbia, 11000
Status Unknown
63
Clinical Centre Nis, Clinic of Children Internal Diseases, Child Neurology Department
Niš, Serbia, 18000
Status Unknown
64
Children Neurology Dept., Institute of Child- and Adolescent Health Care of Vojvodina
Novi Sad, Serbia, 21000
Status Unknown
65
Child Epileptology Out-patient
Dolný Kubín, Slovakia, 026 01
Status Unknown
66
Neurologická ambulancia
Dubnica nad Váhom, Slovakia, 018 41
Status Unknown
67
Neurologická ambulancia
Hlohovec, Slovakia, 92001
Status Unknown
68
Tempus, s.r.o.Child Epileptology Ambulance
Liptovský Mikuláš, Slovakia, 031 04
Status Unknown
69
IMAS Hospital del Mar - Servicio de Pediatria
Barcelona, Spain, 08003
Status Unknown
70
Hospital Vall Hebron
Barcelona, Spain, 8035
Status Unknown
71
Hospital Sant Joan de Déu, Dep. Neuropediatría
Esplugues de Llobregat, Spain, 8950
Status Unknown
72
Hospital Materno Infantil Virgen de las Nieves
Granada, Spain, 18012
Status Unknown
73
Hospital Clínico San Carlos, Servicio de Neurología Pediátrica
Madrid, Spain, 28040
Status Unknown
74
Hospital Son Dureta Dep. Neuropediatría
Palma de Mallorca, Spain, 07014
Status Unknown
75
Hospital Son Dureta, Dep. Neuropediatría
Palma de Mallorca, Spain
Status Unknown
76
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Status Unknown
77
National Taiwan University Hospital - Department of Paediatrics
Taipei, Taiwan, 100
Status Unknown
78
Taipei Veterans General Hospital - Department of Paediatrics
Taipei, Taiwan, 112
Status Unknown
79
Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology
Dnipro, Ukraine, 49027
Status Unknown
80
Institute of Neurology, Psychiatry and Narcology, AMS of Ukraine Acad.
Kharkiv, Ukraine, 61068
Status Unknown
81
Ukrainian Medical Rehabilitation Centre for Children with Organic Disorders of Nervous System
Kiev, Ukraine, 04209
Status Unknown
82
Hospital pediatrics of Odessa State Medical University Odessa
Odesa, Ukraine, 65031
Status Unknown
83
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Status Unknown
84
Crawley Hospital
Crawley, United Kingdom, RH11 7DH
Status Unknown
85
Department of Paediatric, Clarendon Wing, Leeds General Infirmary
Leeds, United Kingdom, LS2 9NS
Status Unknown
86
The Royal London Hospital
London, United Kingdom, E1 1BB
Status Unknown
87
St Georges Hospital, Child Development
London, United Kingdom, SW17 OQT
Status Unknown
88
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Status Unknown
89
Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE1 4LP
Status Unknown
90
Queen's Hospital
Romford, United Kingdom, RM7 0AG
Status Unknown
91
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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