Clinical trial NCT00988156: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Epilepsy in Children and Adolescents
Keywords: Epilepsy
Partial
Refractory
Children
Adolescents
Adjunctive
Randomised
Double-blind
Placebo-controlled
Parallel-group
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 304
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change From Baseline in Seizure Frequency
timeFrame: Baseline up to Visit 7
measure: Responder Rate
timeFrame: baseline up to Visit 7
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz
city: Vienna
country: Austria
facility: Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien
city: Banja Luka
country: Bosnia and Herzegovina
facility: Clinical Centre Banja Luka Pediatric Clinic Department of Neurology
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department
city: Osijek
country: Croatia
facility: Clinical hospital Osjek Pediatric clinic, neuropediatric department
city: Zagreb
country: Croatia
facility: Clinic for Children Diseases Zagreb
city: Zagreb
country: Croatia
facility: Clinic for Sick Children "Dr. Sabol"
city: Brno
country: Czechia
facility: Clinic of the Child Neurology, FN Brno
city: Hradec Králové
country: Czechia
facility: Neurology Policlinic
city: Ostrava
country: Czechia
facility: Child Neurology Clinic of the DNsP Ostrava
city: Praha 4
country: Czechia
facility: Department of the Child Neurology FTN
city: Praha 5
country: Czechia
facility: Children Neurology Clinic, University Hospital Motol
city: Amiens
country: France
facility: CHU Hopital Nord
city: Bordeaux
country: France
facility: Hopital Pédiatrique Enfants
city: Marseille
country: France
facility: Hopital Enfants de la Timone
city: Paris
country: France
facility: Université Paris Descartes, Hopital Necker-Enfants Malades, Département de Neuropédiatrie
city: Toulouse
country: France
facility: Hopital des Enfants
city: Kehl-Kork
country: Germany
facility: Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche
city: Ludwigshafen
country: Germany
facility: Familienpraxis Oggersheim
city: Budapest
country: Hungary
facility: Budai Gyermekkórház, Buda Children's Hospital and Outpatient Clinic
city: Miskolc
country: Hungary
facility: Children Neurology Dept., Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem AOK Gyermekklinika
city: Cagliari
country: Italy
facility: A.O.U. di Cagliari Clinica di neurologia infantile
city: Genova
country: Italy
facility: Ospedale Petiatrico IRCCS
city: Mantova
country: Italy
facility: A. O. C. "Poma"
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Casimiro Mondino
city: Rome
country: Italy
facility: Dipartimento di Neuroscienze, Unità Operativa di Neurologia Ospedale Bambin Gesù
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese Ospedale Santa Maria alle Scotte Dipartimento materno infantile Struttura Complessa di Pediatria
city: Verona
country: Italy
facility: Servizio di Neuropsichiatria Infantile Policlinico "G.B. Rossi" Borgo Roma
city: Kelantan
country: Malaysia
facility: Hospital Raja Perempuan Zainab II - Jabatan Paediatrik
city: Selangor
country: Malaysia
facility: University Putra Malaysia/Hospital Serdang - Department of Paediatrics, Faculty of Medicine and Health Sciences
city: Chishinau
country: Moldova, Republic of
facility: IMSP Centrul National Stiintifico-Practic Medicina de Urgenta
city: Cebu City
country: Philippines
facility: Cebu Davao Doctors Hospital
state: Cebu
city: Cebu City
country: Philippines
facility: Perpetual Succour Hospital - Neuroscience Center, 7/F SPC Medical Specialty Center
state: Cebu
city: Davao City
country: Philippines
facility: Davao Doctor's Hospital
state: Davao Del Sur
city: Ermita
country: Philippines
facility: Manila Doctors Hospital - Child Nueroscience Center
state: Manila
city: Santa Cruz
country: Philippines
facility: Jose R. Reyes Memorial Medical Center - 5th Floor, Training and Research Office, Jose Reyes Memorial Hospital
state: Manila
city: Katowice
country: Poland
facility: 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: Krakow
country: Poland
facility: Krakowski Szpital, Specjalistyczny Im. Jana Pawła Ii W Krakowie
city: Kraków
country: Poland
facility: Instytut Neuromedica
city: Kraków
country: Poland
facility: WOJEWÓDZKI SPECJALISTYCZNY SZPITAL DZIECIĘCY im. ŚW. LUDWIKA W KRAKOWIE
city: Poznan
country: Poland
facility: AKADEMIA MEDYCZNA im. Karola Marcinkowskiego w Poznaniu Katedra I Klinika Neurologii Wieku Rozwojowego
city: Warszawa
country: Poland
facility: Przychodnia NEUROSPHERA
city: Łódź
country: Poland
facility: Instytut "Centrum Zdrowia Matki Polki" Klinika Neurologii
city: Coimbra
country: Portugal
facility: Hospital Pediátrico de Coimbra
city: Lisboa
country: Portugal
facility: Hospital Dona Estefânia
city: Lisboa
country: Portugal
facility: Hospital Francisco Xavier
city: Lisboa
country: Portugal
facility: Hospital Santa Maria
city: Matosinhos
country: Portugal
facility: Hospital Pedro Hispano
city: Porto
country: Portugal
facility: Hospital Geral de Santo António
city: Porto
country: Portugal
facility: Hospital Maria Pia
city: Bucharest
country: Romania
facility: Clinica de Neurologie Peciatrica, Spitalul "Alexandru Obregia"
city: Cluj Napoca
country: Romania
facility: Clinical Hospital for children, Paediatric Neurology clinic
city: Timisoara
country: Romania
facility: Spitalul Clinic de Urgenta pentru copii Luis Turcanu, Clinica de Psihiatrie si Neurologie pentru copii si adolescenti
city: Ekaterinburg
country: Russian Federation
facility: Department of Neurolog, Regional Pediatric Clinical Hospital No. 1 Ekaterinburg
city: Moscow
country: Russian Federation
facility: Pediatric Scientific-practical Center of cranio-facial surgery and neurology
city: Moscow
country: Russian Federation
facility: Research Center of Children Health of RAMS
city: Moscow
country: Russian Federation
facility: Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod State Medical Academy Pediatric City Clinical Hospital No. 1
city: Voronezh
country: Russian Federation
facility: Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1
city: Belgrade
country: Serbia
facility: Child Neurology Service, Institute of Mother and Child Healthcare of Serbia "Dr. Vukan Cupic"
city: Belgrade
country: Serbia
facility: Clinic of Neurology and Psychiatry for Children and Youth
city: Nis
country: Serbia
facility: Clinical Centre Nis, Clinic of Children Internal Diseases, Child Neurology Department
city: Novi Sad
country: Serbia
facility: Children Neurology Dept., Institute of Child- and Adolescent Health Care of Vojvodina
city: Dolny Kubin
country: Slovakia
facility: Child Epileptology Out-patient
city: Dubnica nad Váhom
country: Slovakia
facility: Neurologická ambulancia
city: Hlohovec
country: Slovakia
facility: Neurologická ambulancia
city: Liptovský Mikuláš
country: Slovakia
facility: Tempus, s.r.o.Child Epileptology Ambulance
city: Barcelona
country: Spain
facility: IMAS Hospital del Mar - Servicio de Pediatria
city: Barcelona
country: Spain
facility: Hospital Vall Hebron
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu, Dep. Neuropediatría
city: Granada
country: Spain
facility: Hospital Materno Infantil Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos, Servicio de Neurología Pediátrica
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta Dep. Neuropediatría
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta, Dep. Neuropediatría
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital - Department of Paediatrics
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital - Department of Paediatrics
city: Dnepropetrovsk
country: Ukraine
facility: Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology
city: Kharkiv
country: Ukraine
facility: Institute of Neurology, Psychiatry and Narcology, AMS of Ukraine Acad.
city: Kiev
country: Ukraine
facility: Ukrainian Medical Rehabilitation Centre for Children with Organic Disorders of Nervous System
city: Odessa
country: Ukraine
facility: Hospital pediatrics of Odessa State Medical University Odessa
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: Crawley
country: United Kingdom
facility: Crawley Hospital
city: Leeds
country: United Kingdom
facility: Department of Paediatric, Clarendon Wing, Leeds General Infirmary
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: St Georges Hospital, Child Development
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Romford
country: United Kingdom
facility: Queen's Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
References:
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.