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

NCT ID: NCT00988156

Last Updated: 2018-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-07
• Study Completion Date: 2017-08-24

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

Conditions

Partial Epilepsy in Children and Adolescents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Eslicarbazepine acetate

To receive Eslicarbazepine acetate in addition to concomitant therapy

Group Type: ACTIVE_COMPARATOR

Eslicarbazepine acetate (BIA 2-093)

Intervention Type: DRUG

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.

Placebo

To receive placebo in addition to concomitant therapy

Group Type: PLACEBO_COMPARATOR

Eslicarbazepine acetate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

BIA 2093; BIA 2093

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz

Graz, , Austria

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

Vienna, , Austria

Clinical Centre Banja Luka Pediatric Clinic Department of Neurology

Banja Luka, , Bosnia and Herzegovina

Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department

Sarajevo, , Bosnia and Herzegovina

Clinical hospital Osjek Pediatric clinic, neuropediatric department

Osijek, , Croatia

Clinic for Children Diseases Zagreb

Zagreb, , Croatia

Clinic for Sick Children "Dr. Sabol"

Zagreb, , Croatia

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

Prague, , Czechia

Children Neurology Clinic, University Hospital Motol

Prague, , Czechia

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, , France

Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche

Kehl-Kork, , Germany

Familienpraxis Oggersheim

Ludwigshafen, , Germany

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, , Hungary

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, , Italy

Hospital Raja Perempuan Zainab II - Jabatan Paediatrik

Kelantan, Kelantan, Malaysia

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

Kuala Selangor, Selangor, Malaysia

IMSP Centrul National Stiintifico-Practic Medicina de Urgenta

Chishinau, , Moldova

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, Philippines

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

Instytut Neuromedica

Krakow, , Poland

Krakowski Szpital, Specjalistyczny Im. Jana Pawła Ii W Krakowie

Krakow, , Poland

WOJEWÓDZKI SPECJALISTYCZNY SZPITAL DZIECIĘCY im. ŚW. LUDWIKA W KRAKOWIE

Krakow, , Poland

Instytut "Centrum Zdrowia Matki Polki" Klinika Neurologii

Lodz, , Poland

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

Poznan, , Poland

Przychodnia NEUROSPHERA

Warsaw, , Poland

Hospital Pediátrico de Coimbra

Coimbra, , Portugal

Hospital Dona Estefânia

Lisbon, , Portugal

Hospital Francisco Xavier

Lisbon, , Portugal

Hospital Santa Maria

Lisbon, , Portugal

Hospital Pedro Hispano

Matosinhos Municipality, , Portugal

Hospital Geral de Santo António

Porto, , Portugal

Hospital Maria Pia

Porto, , Portugal

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

Timișoara, , Romania

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

Moscow, , Russia

Research Center of Children Health of RAMS

Moscow, , Russia

Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology

Moscow, , Russia

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

Nizhny Novgorod, , Russia

Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1

Voronezh, , Russia

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

Yekaterinburg, , Russia

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

Niš, , Serbia

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

Novi Sad, , Serbia

Child Epileptology Out-patient

Dolný Kubín, , Slovakia

Neurologická ambulancia

Dubnica nad Váhom, , Slovakia

Neurologická ambulancia

Hlohovec, , Slovakia

Tempus, s.r.o.Child Epileptology Ambulance

Liptovský Mikuláš, , Slovakia

IMAS Hospital del Mar - Servicio de Pediatria

Barcelona, , Spain

Hospital Vall Hebron

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, , Spain

National Taiwan University Hospital - Department of Paediatrics

Taipei, , Taiwan

Taipei Veterans General Hospital - Department of Paediatrics

Taipei, , Taiwan

Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology

Dnipro, , 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

Odesa, , Ukraine

Birmingham Children's Hospital

Birmingham, , United Kingdom

Crawley Hospital

Crawley, , United Kingdom

Department of Paediatric, Clarendon Wing, Leeds General Infirmary

Leeds, , United Kingdom

The Royal London Hospital

London, , United Kingdom

St Georges Hospital, Child Development

London, , United Kingdom

Great Ormond Street 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, , United Kingdom

Countries

Austria; Bosnia and Herzegovina; Croatia; Czechia; France; Germany; Hungary; Italy; Malaysia; Moldova; Philippines; Poland; Portugal; Romania; Russia; Serbia; Slovakia; Spain; Taiwan; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31878820 (View on PubMed)

Related Links

https://www.bial.com/en/r_d.2/transparency.208/clinical_trials.209/eslicarbazepine_acetate.210.html

Sponsor Web page for Clinical Trials Transparency

https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-001887-55/results

EU Clinical Trials Register: Clinical Trial Results

Other Identifiers

2007-001887-55

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BIA-2093-305

Identifier Type: -

Identifier Source: org_study_id