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

Partial Epilepsy in Children and Adolescents Clinical Trial

Official title:

Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988156
• Other study ID #: BIA-2093-305
• Secondary ID: 2007-001887-55
• Status: Completed
• Phase: Phase 3
• Start date: December 7, 2007
• Est. completion date: August 24, 2017

Study information

• Verified date: October 2018
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: August 24, 2017
• Est. primary completion date: August 20, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Partial Epilepsy in Children and Adolescents
• Seizures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz	Graz
Austria	Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien	Vienna
Bosnia and Herzegovina	Clinical Centre Banja Luka Pediatric Clinic Department of Neurology	Banja Luka
Bosnia and Herzegovina	Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department	Sarajevo
Croatia	Clinical hospital Osjek Pediatric clinic, neuropediatric department	Osijek
Croatia	Clinic for Children Diseases Zagreb	Zagreb
Croatia	Clinic for Sick Children "Dr. Sabol"	Zagreb
Czechia	Clinic of the Child Neurology, FN Brno	Brno
Czechia	Neurology Policlinic	Hradec Králové
Czechia	Child Neurology Clinic of the DNsP Ostrava	Ostrava
Czechia	Department of the Child Neurology FTN	Praha 4
Czechia	Children Neurology Clinic, University Hospital Motol	Praha 5
France	CHU Hopital Nord	Amiens
France	Hopital Pédiatrique Enfants	Bordeaux
France	Hopital Enfants de la Timone	Marseille
France	Université Paris Descartes, Hopital Necker-Enfants Malades, Département de Neuropédiatrie	Paris
France	Hopital des Enfants	Toulouse
Germany	Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche	Kehl-Kork
Germany	Familienpraxis Oggersheim	Ludwigshafen
Hungary	Budai Gyermekkórház, Buda Children's Hospital and Outpatient Clinic	Budapest
Hungary	Children Neurology Dept., Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház	Miskolc
Hungary	Pécsi Tudományegyetem AOK Gyermekklinika	Pécs
Italy	A.O.U. di Cagliari Clinica di neurologia infantile	Cagliari
Italy	Ospedale Petiatrico IRCCS	Genova
Italy	A. O. C. "Poma"	Mantova
Italy	Fondazione Istituto Neurologico Casimiro Mondino	Pavia
Italy	Dipartimento di Neuroscienze, Unità Operativa di Neurologia Ospedale Bambin Gesù	Rome
Italy	Azienda Ospedaliera Universitaria Senese Ospedale Santa Maria alle Scotte Dipartimento materno infantile Struttura Complessa di Pediatria	Siena
Italy	Servizio di Neuropsichiatria Infantile Policlinico "G.B. Rossi" Borgo Roma	Verona
Malaysia	Hospital Raja Perempuan Zainab II - Jabatan Paediatrik	Kelantan
Malaysia	University Putra Malaysia/Hospital Serdang - Department of Paediatrics, Faculty of Medicine and Health Sciences	Selangor
Moldova, Republic of	IMSP Centrul National Stiintifico-Practic Medicina de Urgenta	Chishinau
Philippines	Cebu Davao Doctors Hospital	Cebu City	Cebu
Philippines	Perpetual Succour Hospital - Neuroscience Center, 7/F SPC Medical Specialty Center	Cebu City	Cebu
Philippines	Davao Doctor's Hospital	Davao City	Davao Del Sur
Philippines	Manila Doctors Hospital - Child Nueroscience Center	Ermita	Manila
Philippines	Jose R. Reyes Memorial Medical Center - 5th Floor, Training and Research Office, Jose Reyes Memorial Hospital	Santa Cruz	Manila
Poland	SAMODZIELNY PUBLICZNY SZPITAL KLINICZNY NR 6 SLASKIEJ AKADEMII MEDYCZNEJ W KATOWICACH GÓRNOSLASKIE CENTRUM ZDROWIA DZIECKA I MATKI IM. JANA PAWLA II Klinika Pediatrii i Neurologii Wieku Rozwojowego	Katowice
Poland	Krakowski Szpital, Specjalistyczny Im. Jana Pawla Ii W Krakowie	Krakow
Poland	Instytut Neuromedica	Kraków
Poland	WOJEWÓDZKI SPECJALISTYCZNY SZPITAL DZIECIECY im. SW. LUDWIKA W KRAKOWIE	Kraków
Poland	Instytut "Centrum Zdrowia Matki Polki" Klinika Neurologii	Lódz
Poland	AKADEMIA MEDYCZNA im. Karola Marcinkowskiego w Poznaniu Katedra I Klinika Neurologii Wieku Rozwojowego	Poznan
Poland	Przychodnia NEUROSPHERA	Warszawa
Portugal	Hospital Pediátrico de Coimbra	Coimbra
Portugal	Hospital Dona Estefânia	Lisboa
Portugal	Hospital Francisco Xavier	Lisboa
Portugal	Hospital Santa Maria	Lisboa
Portugal	Hospital Pedro Hispano	Matosinhos
Portugal	Hospital Geral de Santo António	Porto
Portugal	Hospital Maria Pia	Porto
Romania	Clinica de Neurologie Peciatrica, Spitalul "Alexandru Obregia"	Bucharest
Romania	Clinical Hospital for children, Paediatric Neurology clinic	Cluj Napoca
Romania	Spitalul Clinic de Urgenta pentru copii Luis Turcanu, Clinica de Psihiatrie si Neurologie pentru copii si adolescenti	Timisoara
Russian Federation	Department of Neurolog, Regional Pediatric Clinical Hospital No. 1 Ekaterinburg	Ekaterinburg
Russian Federation	Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology	Moscow
Russian Federation	Pediatric Scientific-practical Center of cranio-facial surgery and neurology	Moscow
Russian Federation	Research Center of Children Health of RAMS	Moscow
Russian Federation	Nizhny Novgorod State Medical Academy Pediatric City Clinical Hospital No. 1	Nizhny Novgorod
Russian Federation	Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1	Voronezh
Serbia	Child Neurology Service, Institute of Mother and Child Healthcare of Serbia "Dr. Vukan Cupic"	Belgrade
Serbia	Clinic of Neurology and Psychiatry for Children and Youth	Belgrade
Serbia	Clinical Centre Nis, Clinic of Children Internal Diseases, Child Neurology Department	Nis
Serbia	Children Neurology Dept., Institute of Child- and Adolescent Health Care of Vojvodina	Novi Sad
Slovakia	Child Epileptology Out-patient	Dolny Kubin
Slovakia	Neurologická ambulancia	Dubnica nad Váhom
Slovakia	Neurologická ambulancia	Hlohovec
Slovakia	Tempus, s.r.o.Child Epileptology Ambulance	Liptovský Mikuláš
Spain	Hospital Vall Hebron	Barcelona
Spain	IMAS Hospital del Mar - Servicio de Pediatria	Barcelona
Spain	Hospital Sant Joan de Déu, Dep. Neuropediatría	Esplugues de Llobregat
Spain	Hospital Materno Infantil Virgen de las Nieves	Granada
Spain	Hospital Clínico San Carlos, Servicio de Neurología Pediátrica	Madrid
Spain	Hospital Son Dureta Dep. Neuropediatría	Palma de Mallorca
Spain	Hospital Son Dureta, Dep. Neuropediatría	Palma de Mallorca
Spain	Hospital Universitario Miguel Servet	Zaragoza
Taiwan	National Taiwan University Hospital - Department of Paediatrics	Taipei City
Taiwan	Taipei Veterans General Hospital - Department of Paediatrics	Taipei City
Ukraine	Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology	Dnepropetrovsk
Ukraine	Institute of Neurology, Psychiatry and Narcology, AMS of Ukraine Acad.	Kharkiv
Ukraine	Ukrainian Medical Rehabilitation Centre for Children with Organic Disorders of Nervous System	Kiev
Ukraine	Hospital pediatrics of Odessa State Medical University Odessa	Odessa
United Kingdom	Birmingham Children's Hospital	Birmingham
United Kingdom	Crawley Hospital	Crawley
United Kingdom	Department of Paediatric, Clarendon Wing, Leeds General Infirmary	Leeds
United Kingdom	Great Ormond Street Hospital	London
United Kingdom	St Georges Hospital, Child Development	London
United Kingdom	The Royal London Hospital	London
United Kingdom	Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne
United Kingdom	Queen's Hospital	Romford
United Kingdom	Southampton General Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Countries where clinical trial is conducted

Austria,  Bosnia and Herzegovina,  Croatia,  Czechia,  France,  Germany,  Hungary,  Italy,  Malaysia,  Moldova, Republic of,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to Visit 7
Primary	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.	baseline up to Visit 7

External Links

•   EU Clinical Trials Register: Clinical Trial Results
•   Sponsor Web page for Clinical Trials Transparency