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

NCT00988156 | Completed Phase 3 Results

• 2 other identifiers: BIA-2093-3052007-001887-55
• Study Type: interventional
• Target: 304
• Locations: 21 countries
• Sites: 91

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.

Conditions

Partial Epilepsy in Children and Adolescents

Keywords

Epilepsy; Partial; Refractory; Children; Adolescents; Adjunctive; Randomised; Double-blind; Placebo-controlled; Parallel-group

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Eslicarbazepine acetate

ACTIVE COMPARATOR

To receive Eslicarbazepine acetate in addition to concomitant therapy

Drug: Eslicarbazepine acetate (BIA 2-093)

Placebo

PLACEBO COMPARATOR

To receive placebo in addition to concomitant therapy

Drug: Eslicarbazepine acetate

Interventions

Eslicarbazepine acetate (BIA 2-093) 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.

Also known as: BIA 2093

Eslicarbazepine acetate

Eslicarbazepine acetate 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.

Also known as: BIA 2093

Placebo

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (91)

Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz

Graz, 8036, Austria

Location

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

Vienna, 1090, Austria

Location

Clinical Centre Banja Luka Pediatric Clinic Department of Neurology

Banja Luka, 78000, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department

Sarajevo, 71000, Bosnia and Herzegovina

Location

Clinical hospital Osjek Pediatric clinic, neuropediatric department

Osijek, 31 000, Croatia

Location

Clinic for Children Diseases Zagreb

Zagreb, 10 000, Croatia

Location

Clinic for Sick Children "Dr. Sabol"

Zagreb, 10 000, Croatia

Location

Clinic of the Child Neurology, FN Brno

Brno, 613 00, Czechia

Location

Neurology Policlinic

Hradec Králové, 500 03, Czechia

Location

Child Neurology Clinic of the DNsP Ostrava

Ostrava, 708 52, Czechia

Location

Department of the Child Neurology FTN

Prague, 140 59, Czechia

Location

Children Neurology Clinic, University Hospital Motol

Prague, 150 00, Czechia

Location

CHU Hopital Nord

Amiens, 80054 Cedex, France

Location

Hopital Pédiatrique Enfants

Bordeaux, 33000, France

Location

Hopital Enfants de la Timone

Marseille, 13385 Cedex 5, France

Location

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

Paris, 75015, France

Location

Hopital des Enfants

Toulouse, 31026 Cedex, France

Location

Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche

Kehl-Kork, 77694, Germany

Location

Familienpraxis Oggersheim

Ludwigshafen, 67071, Germany

Location

Budai Gyermekkórház, Buda Children's Hospital and Outpatient Clinic

Budapest, 1023, Hungary

Location

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

Miskolc, 3526, Hungary

Location

Pécsi Tudományegyetem AOK Gyermekklinika

Pécs, 7623, Hungary

Location

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

Cagliari, 09124, Italy

Location

Ospedale Petiatrico IRCCS

Genova, 16147, Italy

Location

A. O. C. "Poma"

Mantova, 46100, Italy

Location

Fondazione Istituto Neurologico Casimiro Mondino

Pavia, 27100, Italy

Location

Dipartimento di Neuroscienze, Unità Operativa di Neurologia Ospedale Bambin Gesù

Rome, 00165, Italy

Location

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

Siena, 53100, Italy

Location

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

Verona, 37126, Italy

Location

Hospital Raja Perempuan Zainab II - Jabatan Paediatrik

Kelantan, Kelantan, 15586, Malaysia

Location

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

Kuala Selangor, Selangor, 43400, Malaysia

Location

IMSP Centrul National Stiintifico-Practic Medicina de Urgenta

Chishinau, 2004, Moldova

Location

Cebu Davao Doctors Hospital

Cebu City, Cebu, 6000, Philippines

Location

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

Cebu City, Cebu, 6000, Philippines

Location

Davao Doctor's Hospital

Davao City, Davao Del Sur, 8000, Philippines

Location

Manila Doctors Hospital - Child Nueroscience Center

Ermita, Manila, 1000, Philippines

Location

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

Santa Cruz, Manila, 1003, Philippines

Location

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, 40-752, Poland

Location

Instytut Neuromedica

Krakow, 30-418, Poland

Location

Krakowski Szpital, Specjalistyczny Im. Jana Pawła Ii W Krakowie

Krakow, 31-202, Poland

Location

WOJEWÓDZKI SPECJALISTYCZNY SZPITAL DZIECIĘCY im. ŚW. LUDWIKA W KRAKOWIE

Krakow, 31-503, Poland

Location

Instytut "Centrum Zdrowia Matki Polki" Klinika Neurologii

Lodz, 93-338, Poland

Location

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

Poznan, 60-355, Poland

Location

Przychodnia NEUROSPHERA

Warsaw, 02-942, Poland

Location

Hospital Pediátrico de Coimbra

Coimbra, 3000-076, Portugal

Location

Hospital Dona Estefânia

Lisbon, 1169-045, Portugal

Location

Hospital Francisco Xavier

Lisbon, 1495-005, Portugal

Location

Hospital Santa Maria

Lisbon, 1649-035, Portugal

Location

Hospital Pedro Hispano

Matosinhos Municipality, 4454-509, Portugal

Location

Hospital Geral de Santo António

Porto, 4050-060, Portugal

Location

Hospital Maria Pia

Porto, 4050-111, Portugal

Location

Clinica de Neurologie Peciatrica, Spitalul "Alexandru Obregia"

Bucharest, 041914, Romania

Location

Clinical Hospital for children, Paediatric Neurology clinic

Cluj-Napoca, 400084, Romania

Location

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

Timișoara, 300011, Romania

Location

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

Moscow, 119620, Russia

Location

Research Center of Children Health of RAMS

Moscow, 119991, Russia

Location

Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology

Moscow, 127412, Russia

Location

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

Nizhny Novgorod, 603081, Russia

Location

Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1

Voronezh, 394024, Russia

Location

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

Yekaterinburg, 620149, Russia

Location

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

Belgrade, 11000, Serbia

Location

Clinic of Neurology and Psychiatry for Children and Youth

Belgrade, 11000, Serbia

Location

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

Niš, 18000, Serbia

Location

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

Novi Sad, 21000, Serbia

Location

Child Epileptology Out-patient

Dolný Kubín, 026 01, Slovakia

Location

Neurologická ambulancia

Dubnica nad Váhom, 018 41, Slovakia

Location

Neurologická ambulancia

Hlohovec, 92001, Slovakia

Location

Tempus, s.r.o.Child Epileptology Ambulance

Liptovský Mikuláš, 031 04, Slovakia

Location

IMAS Hospital del Mar - Servicio de Pediatria

Barcelona, 08003, Spain

Location

Hospital Vall Hebron

Barcelona, 8035, Spain

Location

Hospital Sant Joan de Déu, Dep. Neuropediatría

Esplugues de Llobregat, 8950, Spain

Location

Hospital Materno Infantil Virgen de las Nieves

Granada, 18012, Spain

Location

Hospital Clínico San Carlos, Servicio de Neurología Pediátrica

Madrid, 28040, Spain

Location

Hospital Son Dureta Dep. Neuropediatría

Palma de Mallorca, 07014, Spain

Location

Hospital Son Dureta, Dep. Neuropediatría

Palma de Mallorca, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

National Taiwan University Hospital - Department of Paediatrics

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital - Department of Paediatrics

Taipei, 112, Taiwan

Location

Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology

Dnipro, 49027, Ukraine

Location

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

Kharkiv, 61068, Ukraine

Location

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

Kiev, 04209, Ukraine

Location

Hospital pediatrics of Odessa State Medical University Odessa

Odesa, 65031, Ukraine

Location

Birmingham Children's Hospital

Birmingham, B4 6NH, United Kingdom

Location

Crawley Hospital

Crawley, RH11 7DH, United Kingdom

Location

Department of Paediatric, Clarendon Wing, Leeds General Infirmary

Leeds, LS2 9NS, United Kingdom

Location

The Royal London Hospital

London, E1 1BB, United Kingdom

Location

St Georges Hospital, Child Development

London, SW17 OQT, United Kingdom

Location

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

Location

Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Queen's Hospital

Romford, RM7 0AG, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31878820 DERIVED

Related Links

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

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Director R&D
• Organization: BIAL - Portela & Cª, S.A.

clinical.trials@bial.com

351-22-9866100

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: December 7, 2007
• Primary Completion: August 20, 2012
• Study Completion: August 24, 2017
• Last Updated: November 13, 2018
• Results First Posted: July 17, 2014

Record last verified: 2018-10

Locations

PT (7); GB (9); AU (2); IT (7); RU (6); ES (8); HU (3); TW (2); CZ (5); SE (4); MO (1); BO (2); DE (2); MY (2); RO (3); SL (4); UA (4); PH (5); FR (5); PL (7); CR (3)