EpilepsyPhase 3NCT01422720
Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients
A Phase 3 study testing Eslicarbazepine Acetate in people with Epilepsy, run by Bial - Portela C S.A. at 48 sites in 10 countries.
Trial summary
This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Eslicarbazepine Acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 48 sitesin 10 countries
- Study dates
- Apr 2010to Sep 2013
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Written informed consent form;
- Of age 65 years or older;
- A documented diagnosis of epilepsy for at least 12 months,
- At least 2 partial-onset seizures (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) in the 4 weeks prior to screening;
- Currently treated with 1 or 2 AEDs (any except oxcarbazepine) in a stable dosage regimen for at least 4 weeks prior to screening. Vagus nerve stimulation (VNS) is to be considered as an AED (i.e., only one concomitant AED is allowed in patients with VNS);
- Willing and able to comply with all trial requirements, in the judgment of the investigator;
- At least 2 partial-onset seizures (documented in the diary) per 4 weeks during the 8-week baseline period;
- Satisfactorily complied with the study requirements during the baseline period
Who cannot join
- Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures);
- Primarily generalised seizures;
- Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
- Occurrence of seizures too close to count accurately;
- History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening;
- Seizures of non-epileptic origin;
Show all 17Show fewer
- Major psychiatric disorders;
- History of suicide attempt;
- Currently treated with oxcarbazepine;
- Previous use of ESL or participation in a clinical study with ESL;
- Known hypersensitivity to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients;
- Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo - or hyper thyroidism of any type;
- Second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator;
- Relevant clinical laboratory abnormalities as determined by the investigator (e.g. plasma sodium <130 mmol/L, alanine or aspartate aminotransferases >2.0 times above the upper limit of the range, or white blood cell count <3,000 cells/mm3;
- Calculated creatinine values < 30 mL/min at screening;
- Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol;
- Received an investigational drug (or a medical device) within 3 months of screening or is currently participating in another trial of an investigational drug (or medical device) trial.
Trial locations and contacts
48 sites in 10 countries.
48 sites in 10 countries
Czechia7 sites
Neurologická klinika, FN u Sv. Anny
Brno
NZZ BORMED s.r.o.
Ostrava - Třebovice
Neurologická ambulance
Pilsen
Clintrial, s.r.o.
Prague
Medical Services Prague s.r.o.
Prague
Oddělení neurologie, FN Bulovka
Prague
Fakultní Thomayerova nemocnice s poliklinikou, Neurologická klinika
Praha 4 - Krč
Germany7 sites
Klinik für Epileptologie Universität Bonn
Bonn
Zentrum Epilepsie Erlangen
Erlangen
Diakonie Kork, Epilepsiezentrum
Kehl-Kork
IZKS; Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
Mainz
Studienzentrum Dr. Stephan Arnold
München
Neurologische Gemeinschaftspraxis am Seelberg
Stuttgart
Universitäts- und Rehabilitationskliniken Ulm (RKU), Klinik für Neurologie
Ulm
Bulgaria6 sites
4 MHAT Sofia
Sofia
Diagnostic & Consultative Center "Sveta Anna" EOOD
Sofia
First MHAT-Sofia
Sofia
UMHAT "Aleksandrovska"
Sofia
UMHAT "Tsaritsa Yoanna -ISUL"
Sofia
MHAT "Prof. Stoyan Kirkovich"
Stara Zagora
Spain6 sites
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
IMAS Hospital del Mar
Barcelona
Hospital Clínico San Carlos
Madrid
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario Virgen Macarena
Seville
Portugal5 sites
AIBILI - Centro de Estudos de Biodisponibildade
Coimbra
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Staª Maria - Centro de Estudos Egas Moniz
Lisbon
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon
Unidade Local de Saúde de Alto Minho, EPE - Hospital de Santa Luzia - Serviço de Neurologi
Viana do Castelo
Centro Hospitalar de Trás-os -Montes e Alto-Douro, EPE - Hospital de São Pedro - Serviço de Neurologia
Vila Real
Poland4 sites
"Klinika Neurologii Rozwojowej
Gdansk
Centrum Leczenia Padaczki i Migreny
Krakow
Małopolskie Centrum Medyczne s.c.
Krakow
Centrum Terapii Współczesnej
Lodz
Romania4 sites
C.M.D.T.A. Neomed
Brasov
Cabinet Medical Individual "Dr. Roceanu Adina Maria" -Neurologie, Neurofiziologie (EEG, EMG, PEC)
Bucharest
Sc Clubul Sanatatii Srl
Campulung Muscel
Spitalul Clinic de Neuropsihiatrie Craiova
Craiova; Jud. Dolj
Austria3 sites
Universitätsklinik für Neurologie; Arbeitsgruppe Epileptologie
Innsbruck
Universitätsklinik für Neurologie; Christian-Doppler-Klinik
Salzburg
Medizinische Universitat Wien Klinik fur Neurologie
Vienna
Croatia3 sites
General County Hospital Požega, Neurology department
Požega
Polyclinic for neurology and psychiatry 'Interneuron
Rijeka
Clinical Hospital Centre Split
Split
France3 sites
Hôpital Gui de Chauliac, Explorations neurologiques et d'épileptologie
Montpellier
Hôpital Central - Service de Neurologie
Nancy
Groupement Hospitalier Universitaire Est, Pitié-Salpétrière; Clinique des Maladies du Système Nerveux
Paris
About this study
Official title: Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients
This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients.
Read the detailed description
Multicenter study in approximately 100 elderly patients. The study will follow an open-label design and will consist of 8-week baseline period, followed by a 26-week treatment period and a 4-week follow-up period.
- Conditions
- Epilepsy
- Being tested
- Eslicarbazepine Acetate
- Keywords
- Epilepsy, ESL, Eslicarbazepine Acetate, BIAL, BIA, Partial-onset Seizures
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eslicarbazepine AcetateDrug
Also called Zebinix
ESL tablets (800 mg) QD
| Study group | Role | What they receive |
|---|---|---|
| Eslicarbazepine Acetate tablets (800 mg) | Experimental | Not described Receives: Drug: Eslicarbazepine Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Reported Adverse Events (AE)
An AE was defined as Treatment-Emergent Adverse Event (TEAE), if first onset or worsening was after the first intake of investigational medicinal product (IMP) and not more than 14 days after the last administration of IMP.
TEAE assessment:
- patients who died
- patients who died due to Treatment-emergent adverse event (TEAE)
- patients with at least one Serious Adverse Event (SAE)
- patients with at least one Treatment-emergent Serious Adverse Event (TESAE)
- patients prematurely terminated due to TEAE
- patients with at least one TEAE
- patients with at least one related TEAE
- patients with at least one severe TEAE
- patients without any TEAE
Measured: throughout the study
Secondary outcomes (1)
Change From Baseline in Standardized Seizure Frequency
Absolute and relative changes from baseline of seizure frequency standardised to a frequency per 4 weeks.
Measured: 8-week Baseline Period and 26-week Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startApr 2010
- Primary completionSep 2013
- Study completionSep 2013
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.
- Other trials for EpilepsyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 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
- NCT01422720
- Sponsor's protocol ID
- BIA-2093-401
- Other IDs
- 0140BI17.MPB, 2009-012587-14, 2009
- Status last verified
- Jun 2017
- First submitted
- 29 Jul 2011
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients
- ClinicalTrials.gov ID
- NCT01422720
- Acronym / sponsor ID
- BIA-2093-401
- Conditions
- Epilepsy
- Keywords
- Epilepsy, ESL, Eslicarbazepine Acetate, BIAL, BIA, Partial-onset Seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Aug 2011 (estimated)
- Results
- Posted 18 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients.
Detailed description
Multicenter study in approximately 100 elderly patients. The study will follow an open-label design and will consist of 8-week baseline period, followed by a 26-week treatment period and a 4-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eslicarbazepine Acetate tablets (800 mg) | Experimental | Drug: Eslicarbazepine Acetate |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Written informed consent form;
- Of age 65 years or older;
- A documented diagnosis of epilepsy for at least 12 months,
- At least 2 partial-onset seizures (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) in the 4 weeks prior to screening;
- Currently treated with 1 or 2 AEDs (any except oxcarbazepine) in a stable dosage regimen for at least 4 weeks prior to screening. Vagus nerve stimulation (VNS) is to be considered as an AED (i.e., only one concomitant AED is allowed in patients with VNS);
Key exclusion criteria (17 listed)
- Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures);
- Primarily generalised seizures;
- Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
- Occurrence of seizures too close to count accurately;
- History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening;
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 AcetateAlso: ZebinixESL tablets (800 mg) QD | Drug | Eslicarbazepine Acetate tablets (800 mg) |
Primary outcome
Number of Subjects With Reported Adverse Events (AE)
Time frame: throughout the study
An AE was defined as Treatment-Emergent Adverse Event (TEAE), if first onset or worsening was after the first intake of investigational medicinal product (IMP) and not more than 14 days after the last administration of IMP. TEAE assessment: * patients who died * patients who died due to Treatment-emergent adverse event (TEAE) * patients with at least one Serious Adverse Event (SAE) * patients with at least one Treatment-emergent Serious Adverse Event (TESAE) * patients prematurely terminated due to TEAE * patients with at least one TEAE * patients with at least one related TEAE * patients with at least one severe TEAE * patients without any TEAE
1 secondary outcome
Change From Baseline in Standardized Seizure Frequency
Time frame: 8-week Baseline Period and 26-week Treatment Period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
48 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eslicarbazepine Acetate in people with Epilepsy, run by Bial - Portela C S.A. at 48 sites in 10 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 8 inclusion and 17 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 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Czechia, Germany, Bulgaria, Spain, Portugal and 5 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. 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 18 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?
Number of Subjects With Reported Adverse Events (AE) (time frame: throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2017.