Partial Epilepsy in Children and AdolescentsPhase 3NCT00988156
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
A Phase 3 study testing Eslicarbazepine acetate (BIA 2-093) and Eslicarbazepine acetate in people with Partial Epilepsy in Children and Adolescents, run by Bial - Portela C S.A. at 91 sites in 21 countries.
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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Partial Epilepsy in Children and Adolescents
- What is being tested?
- Eslicarbazepine acetate (BIA 2-093) and Eslicarbazepine acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 91 sitesin 21 countries
- Study dates
- 7 Dec 2007to 24 Aug 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- West syndrome
- Major psychiatric disorders
- Previous treatment any study with Eslicarbazepine acetate
Trial locations and contacts
91 sites in 21 countries.
91 sites in 21 countries
United Kingdom9 sites
Birmingham Children's Hospital
Birmingham, B4 6NH
Crawley Hospital
Crawley, RH11 7DH
Department of Paediatric, Clarendon Wing, Leeds General Infirmary
Leeds, LS2 9NS
The Royal London Hospital
London, E1 1BB
St Georges Hospital, Child Development
London, SW17 OQT
Great Ormond Street Hospital
London, WC1N 3JH
Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP
Queen's Hospital
Romford, RM7 0AG
Southampton General Hospital
Southampton, SO16 6YD
Spain8 sites
IMAS Hospital del Mar - Servicio de Pediatria
Barcelona, 08003
Hospital Vall Hebron
Barcelona, 8035
Hospital Sant Joan de Déu, Dep. Neuropediatría
Esplugues de Llobregat, 8950
Hospital Materno Infantil Virgen de las Nieves
Granada, 18012
Hospital Clínico San Carlos, Servicio de Neurología Pediátrica
Madrid, 28040
Hospital Son Dureta Dep. Neuropediatría
Palma de Mallorca, 07014
Hospital Son Dureta, Dep. Neuropediatría
Palma de Mallorca
Hospital Universitario Miguel Servet
Zaragoza, 50009
Italy7 sites
A.O.U. di Cagliari Clinica di neurologia infantile
Cagliari, 09124
Ospedale Petiatrico IRCCS
Genova, 16147
A. O. C. "Poma"
Mantua, 46100
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, 27100
Dipartimento di Neuroscienze, Unità Operativa di Neurologia Ospedale Bambin Gesù
Rome, 00165
Azienda Ospedaliera Universitaria Senese Ospedale Santa Maria alle Scotte Dipartimento materno infantile Struttura Complessa di Pediatria
Siena, 53100
Servizio di Neuropsichiatria Infantile Policlinico "G.B. Rossi" Borgo Roma
Verona, 37126
Poland7 sites
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
Instytut Neuromedica
Krakow, 30-418
Krakowski Szpital, Specjalistyczny Im. Jana Pawła Ii W Krakowie
Krakow, 31-202
WOJEWÓDZKI SPECJALISTYCZNY SZPITAL DZIECIĘCY im. ŚW. LUDWIKA W KRAKOWIE
Krakow, 31-503
Instytut "Centrum Zdrowia Matki Polki" Klinika Neurologii
Lodz, 93-338
AKADEMIA MEDYCZNA im. Karola Marcinkowskiego w Poznaniu Katedra I Klinika Neurologii Wieku Rozwojowego
Poznan, 60-355
Przychodnia NEUROSPHERA
Warsaw, 02-942
Portugal7 sites
Hospital Pediátrico de Coimbra
Coimbra, 3000-076
Hospital Dona Estefânia
Lisbon, 1169-045
Hospital Francisco Xavier
Lisbon, 1495-005
Hospital Santa Maria
Lisbon, 1649-035
Hospital Pedro Hispano
Matosinhos Municipality, 4454-509
Hospital Geral de Santo António
Porto, 4050-060
Hospital Maria Pia
Porto, 4050-111
Russia6 sites
Pediatric Scientific-practical Center of cranio-facial surgery and neurology
Moscow, 119620
Research Center of Children Health of RAMS
Moscow, 119991
Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology
Moscow, 127412
Nizhny Novgorod State Medical Academy Pediatric City Clinical Hospital No. 1
Nizhny Novgorod, 603081
Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1
Voronezh, 394024
Department of Neurolog, Regional Pediatric Clinical Hospital No. 1 Ekaterinburg
Yekaterinburg, 620149
Czechia5 sites
Clinic of the Child Neurology, FN Brno
Brno, 613 00
Neurology Policlinic
Hradec Králové, 500 03
Child Neurology Clinic of the DNsP Ostrava
Ostrava, 708 52
Department of the Child Neurology FTN
Prague, 140 59
Children Neurology Clinic, University Hospital Motol
Prague, 150 00
France5 sites
CHU Hopital Nord
Amiens, 80054 Cedex
Hopital Pédiatrique Enfants
Bordeaux, 33000
Hopital Enfants de la Timone
Marseille, 13385 Cedex 5
Université Paris Descartes, Hopital Necker-Enfants Malades, Département de Neuropédiatrie
Paris, 75015
Hopital des Enfants
Toulouse, 31026 Cedex
Philippines5 sites
Cebu Davao Doctors Hospital
Cebu City, Cebu, 6000
Perpetual Succour Hospital - Neuroscience Center, 7/F SPC Medical Specialty Center
Cebu City, Cebu, 6000
Davao Doctor's Hospital
Davao City, Davao Del Sur, 8000
Manila Doctors Hospital - Child Nueroscience Center
Ermita, Manila, 1000
Jose R. Reyes Memorial Medical Center - 5th Floor, Training and Research Office, Jose Reyes Memorial Hospital
Santa Cruz, Manila, 1003
Serbia4 sites
Child Neurology Service, Institute of Mother and Child Healthcare of Serbia "Dr. Vukan Cupic"
Belgrade, 11000
Clinic of Neurology and Psychiatry for Children and Youth
Belgrade, 11000
Clinical Centre Nis, Clinic of Children Internal Diseases, Child Neurology Department
Niš, 18000
Children Neurology Dept., Institute of Child- and Adolescent Health Care of Vojvodina
Novi Sad, 21000
Slovakia4 sites
Child Epileptology Out-patient
Dolný Kubín, 026 01
Neurologická ambulancia
Dubnica nad Váhom, 018 41
Neurologická ambulancia
Hlohovec, 92001
Tempus, s.r.o.Child Epileptology Ambulance
Liptovský Mikuláš, 031 04
Ukraine4 sites
Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology
Dnipro, 49027
Institute of Neurology, Psychiatry and Narcology, AMS of Ukraine Acad.
Kharkiv, 61068
Ukrainian Medical Rehabilitation Centre for Children with Organic Disorders of Nervous System
Kiev, 04209
Hospital pediatrics of Odessa State Medical University Odessa
Odesa, 65031
Croatia3 sites
Clinical hospital Osjek Pediatric clinic, neuropediatric department
Osijek, 31 000
Clinic for Children Diseases Zagreb
Zagreb, 10 000
Clinic for Sick Children "Dr. Sabol"
Zagreb, 10 000
Hungary3 sites
Budai Gyermekkórház, Buda Children's Hospital and Outpatient Clinic
Budapest, 1023
Children Neurology Dept., Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, 3526
Pécsi Tudományegyetem AOK Gyermekklinika
Pécs, 7623
Romania3 sites
Clinica de Neurologie Peciatrica, Spitalul "Alexandru Obregia"
Bucharest, 041914
Clinical Hospital for children, Paediatric Neurology clinic
Cluj-Napoca, 400084
Spitalul Clinic de Urgenta pentru copii Luis Turcanu, Clinica de Psihiatrie si Neurologie pentru copii si adolescenti
Timișoara, 300011
Austria2 sites
Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz
Graz, 8036
Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien
Vienna, 1090
Bosnia and Herzegovina2 sites
Clinical Centre Banja Luka Pediatric Clinic Department of Neurology
Banja Luka, 78000
Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department
Sarajevo, 71000
Germany2 sites
Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche
Kehl-Kork, 77694
Familienpraxis Oggersheim
Ludwigshafen, 67071
Malaysia2 sites
Hospital Raja Perempuan Zainab II - Jabatan Paediatrik
Kelantan, Kelantan, 15586
University Putra Malaysia/Hospital Serdang - Department of Paediatrics, Faculty of Medicine and Health Sciences
Kuala Selangor, Selangor, 43400
Taiwan2 sites
National Taiwan University Hospital - Department of Paediatrics
Taipei, 100
Taipei Veterans General Hospital - Department of Paediatrics
Taipei, 112
Moldova1 site
IMSP Centrul National Stiintifico-Practic Medicina de Urgenta
Chishinau, 2004
About this study
Official title: Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children
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.
Read the 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
- Being tested
- Eslicarbazepine acetate (BIA 2-093), Eslicarbazepine acetate
- Keywords
- Epilepsy, Partial, Refractory, Children, Adolescents, Adjunctive, Randomised, Double-blind, Placebo-controlled, Parallel-group
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eslicarbazepine acetate (BIA 2-093)Drug
Also called BIA 2093
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 acetateDrug
Also called BIA 2093
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.
| Study group | Role | What they receive |
|---|---|---|
| Eslicarbazepine acetate | Active comparator | To receive Eslicarbazepine acetate in addition to concomitant therapy Receives: Drug: Eslicarbazepine acetate (BIA 2-093) |
| Placebo | Placebo comparator | To receive placebo in addition to concomitant therapy Receives: Drug: Eslicarbazepine acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline up to Visit 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study start7 Dec 2007
- Primary completion20 Aug 2012
- Study completion24 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial Epilepsy in Children and AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988156
- Sponsor's protocol ID
- BIA-2093-305
- Other IDs
- 2007-001887-55
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2009
- Last updated
- 13 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 31878820
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children
- ClinicalTrials.gov ID
- NCT00988156
- Acronym / sponsor ID
- BIA-2093-305
- Keywords
- Epilepsy, Partial, Refractory, Children, Adolescents, Adjunctive, Randomised, Double-blind
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2007 (actual)
- Primary completion
- 20 Aug 2012 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 2 Oct 2009 (estimated)
- Results
- Posted 17 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eslicarbazepine acetate | Active comparator | Drug: Eslicarbazepine acetate (BIA 2-093)To receive Eslicarbazepine acetate in addition to concomitant therapy |
| Placebo | Placebo comparator | Drug: Eslicarbazepine acetateTo receive placebo in addition to concomitant therapy |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eslicarbazepine acetate (BIA 2-093)Also: BIA 2093Part 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. | Drug | Eslicarbazepine acetate |
| Eslicarbazepine acetateAlso: BIA 2093Part 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. | Drug | Placebo |
Primary outcome
Change From Baseline in Seizure Frequency
Time frame: Baseline up to Visit 7
Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
Responder Rate
Time frame: baseline up to Visit 7
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31878820Mintz 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.
- Sponsor Web page for Clinical Trials TransparencyLink provided by the sponsor.
- EU Clinical Trials Register: Clinical Trial ResultsLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
91 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eslicarbazepine acetate (BIA 2-093) and Eslicarbazepine acetate in people with Partial Epilepsy in Children and Adolescents, run by Bial - Portela C S.A. at 91 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United Kingdom, Spain, Italy, Poland, Portugal and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Seizure Frequency (time frame: Baseline up to Visit 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00988156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.