Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients
- Registration Number
- NCT01422720
- Lead Sponsor
- Bial - Portela C S.A.
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Eslicarbazepine Acetate tablets (800 mg) Eslicarbazepine Acetate -
- Primary Outcome Measures
Name Time Method Number of Subjects With Reported Adverse Events (AE) 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
- Secondary Outcome Measures
Name Time Method Change From Baseline in Standardized Seizure Frequency 8-week Baseline Period and 26-week Treatment Period Absolute and relative changes from baseline of seizure frequency standardised to a frequency per 4 weeks.
Trial Locations
- Locations (48)
Centro Hospitalar de Trás-os -Montes e Alto-Douro, EPE - Hospital de São Pedro - Serviço de Neurologia
🇵🇹Vila Real, Portugal
Sc Clubul Sanatatii Srl
🇷🇴Campulung Muscel, Romania
Spitalul Clinic de Neuropsihiatrie Craiova
🇷🇴Craiova; Jud. Dolj, Romania
Universitätsklinik für Neurologie; Arbeitsgruppe Epileptologie
🇦🇹Innsbruck, Austria
Unidade Local de Saúde de Alto Minho, EPE - Hospital de Santa Luzia - Serviço de Neurologi
🇵🇹Viana do Castelo, Portugal
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
C.M.D.T.A. Neomed
🇷🇴Brasov, Romania
Cabinet Medical Individual "Dr. Roceanu Adina Maria" -Neurologie, Neurofiziologie (EEG, EMG, PEC)
🇷🇴Bucuresti, Romania
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
IMAS Hospital del Mar
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Diagnostic & Consultative Center "Sveta Anna" EOOD
🇧🇬Sofia, Bulgaria
Universitätsklinik für Neurologie; Christian-Doppler-Klinik
🇦🇹Salzburg, Austria
Medizinische Universitat Wien Klinik fur Neurologie
🇦🇹Wien, Austria
4 MHAT Sofia
🇧🇬Sofia, Bulgaria
First MHAT-Sofia
🇧🇬Sofia, Bulgaria
UMHAT "Aleksandrovska"
🇧🇬Sofia, Bulgaria
UMHAT "Tsaritsa Yoanna -ISUL"
🇧🇬Sofia, Bulgaria
MHAT "Prof. Stoyan Kirkovich"
🇧🇬Stara Zagora, Bulgaria
General County Hospital Požega, Neurology department
🇭🇷Požega, Croatia
Polyclinic for neurology and psychiatry 'Interneuron
🇭🇷Rijeka, Croatia
Clinical Hospital Centre Split
🇭🇷Split, Croatia
Neurologická klinika, FN u Sv. Anny
🇨🇿Brno, Czechia
NZZ BORMED s.r.o.
🇨🇿Ostrava - Třebovice, Czechia
Neurologická ambulance
🇨🇿Plzeň, Czechia
Clintrial, s.r.o.
🇨🇿Praha 10, Czechia
Fakultní Thomayerova nemocnice s poliklinikou, Neurologická klinika
🇨🇿Praha 4 - Krč, Czechia
Medical Services Prague s.r.o.
🇨🇿Praha 6, Czechia
Oddělení neurologie, FN Bulovka
🇨🇿Praha 8, Czechia
Hôpital Gui de Chauliac, Explorations neurologiques et d'épileptologie
🇫🇷Montpellier Cedex 05, France
Hôpital Central - Service de Neurologie
🇫🇷Nancy, France
Groupement Hospitalier Universitaire Est, Pitié-Salpétrière; Clinique des Maladies du Système Nerveux
🇫🇷Paris Cedex 13, France
Zentrum Epilepsie Erlangen
🇩🇪Erlangen, Germany
Klinik für Epileptologie Universität Bonn
🇩🇪Bonn, Germany
Diakonie Kork, Epilepsiezentrum
🇩🇪Kehl-Kork, Germany
IZKS; Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Studienzentrum Dr. Stephan Arnold
🇩🇪München, Germany
Neurologische Gemeinschaftspraxis am Seelberg
🇩🇪Stuttgart, Germany
Universitäts- und Rehabilitationskliniken Ulm (RKU), Klinik für Neurologie
🇩🇪Ulm, Germany
"Klinika Neurologii Rozwojowej
🇵🇱Gdańsk, Poland
Centrum Leczenia Padaczki i Migreny
🇵🇱Kraków, Poland
Małopolskie Centrum Medyczne s.c.
🇵🇱Kraków, Poland
Centrum Terapii Współczesnej
🇵🇱Lodz, Poland
AIBILI - Centro de Estudos de Biodisponibildade
🇵🇹Coimbra, Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Staª Maria - Centro de Estudos Egas Moniz
🇵🇹Lisbon, Portugal
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz
🇵🇹Lisbon, Portugal