Clinical trial NCT01422720: Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients
Official title: Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
ESL
Eslicarbazepine Acetate
BIAL
BIA
Partial-onset Seizures
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2011-08-24
Enrollment: 72
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent form;
2. Of age 65 years or older;
3. A documented diagnosis of epilepsy for at least 12 months,
4. 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;
5. 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);
6. Willing and able to comply with all trial requirements, in the judgment of the investigator;
7. At least 2 partial-onset seizures (documented in the diary) per 4 weeks during the 8-week baseline period;
8. Satisfactorily complied with the study requirements during the baseline period

Exclusion Criteria:

1. Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures);
2. Primarily generalised seizures;
3. Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
4. Occurrence of seizures too close to count accurately;
5. History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening;
6. Seizures of non-epileptic origin;
7. Major psychiatric disorders;
8. History of suicide attempt;
9. Currently treated with oxcarbazepine;
10. Previous use of ESL or participation in a clinical study with ESL;
11. Known hypersensitivity to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients;
12. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo - or hyper thyroidism of any type;
13. Second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator;
14. 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;
15. Calculated creatinine values \< 30 mL/min at screening;
16. Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol;
17. 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.

Primary outcomes:
measure: Number of Subjects With Reported Adverse Events (AE)
timeFrame: throughout the study
Secondary outcomes:
measure: Change From Baseline in Standardized Seizure Frequency
timeFrame: 8-week Baseline Period and 26-week Treatment Period
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitätsklinik für Neurologie; Arbeitsgruppe Epileptologie
city: Salzburg
country: Austria
facility: Universitätsklinik für Neurologie; Christian-Doppler-Klinik
city: Wien
country: Austria
facility: Medizinische Universitat Wien Klinik fur Neurologie
city: Sofia
country: Bulgaria
facility: 4 MHAT Sofia
city: Sofia
country: Bulgaria
facility: Diagnostic & Consultative Center "Sveta Anna" EOOD
city: Sofia
country: Bulgaria
facility: First MHAT-Sofia
city: Sofia
country: Bulgaria
facility: UMHAT "Aleksandrovska"
city: Sofia
country: Bulgaria
facility: UMHAT "Tsaritsa Yoanna -ISUL"
city: Stara Zagora
country: Bulgaria
facility: MHAT "Prof. Stoyan Kirkovich"
city: Požega
country: Croatia
facility: General County Hospital Požega, Neurology department
city: Rijeka
country: Croatia
facility: Polyclinic for neurology and psychiatry 'Interneuron
city: Split
country: Croatia
facility: Clinical Hospital Centre Split
city: Brno
country: Czechia
facility: Neurologická klinika, FN u Sv. Anny
city: Ostrava - Třebovice
country: Czechia
facility: NZZ BORMED s.r.o.
city: Plzeň
country: Czechia
facility: Neurologická ambulance
city: Praha 10
country: Czechia
facility: Clintrial, s.r.o.
city: Praha 4 - Krč
country: Czechia
facility: Fakultní Thomayerova nemocnice s poliklinikou, Neurologická klinika
city: Praha 6
country: Czechia
facility: Medical Services Prague s.r.o.
city: Praha 8
country: Czechia
facility: Oddělení neurologie, FN Bulovka
city: Montpellier Cedex 05
country: France
facility: Hôpital Gui de Chauliac, Explorations neurologiques et d'épileptologie
city: Nancy
country: France
facility: Hôpital Central - Service de Neurologie
city: Paris Cedex 13
country: France
facility: Groupement Hospitalier Universitaire Est, Pitié-Salpétrière; Clinique des Maladies du Système Nerveux
city: Bonn
country: Germany
facility: Klinik für Epileptologie Universität Bonn
city: Erlangen
country: Germany
facility: Zentrum Epilepsie Erlangen
city: Kehl-Kork
country: Germany
facility: Diakonie Kork, Epilepsiezentrum
city: Mainz
country: Germany
facility: IZKS; Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
city: München
country: Germany
facility: Studienzentrum Dr. Stephan Arnold
city: Stuttgart
country: Germany
facility: Neurologische Gemeinschaftspraxis am Seelberg
city: Ulm
country: Germany
facility: Universitäts- und Rehabilitationskliniken Ulm (RKU), Klinik für Neurologie
city: Gdańsk
country: Poland
facility: "Klinika Neurologii Rozwojowej
city: Kraków
country: Poland
facility: Centrum Leczenia Padaczki i Migreny
city: Kraków
country: Poland
facility: Małopolskie Centrum Medyczne s.c.
city: Lodz
country: Poland
facility: Centrum Terapii Współczesnej
city: Coimbra
country: Portugal
facility: AIBILI - Centro de Estudos de Biodisponibildade
city: Lisbon
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Staª Maria - Centro de Estudos Egas Moniz
city: Lisbon
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz
city: Viana do Castelo
country: Portugal
facility: Unidade Local de Saúde de Alto Minho, EPE - Hospital de Santa Luzia - Serviço de Neurologi
city: Vila Real
country: Portugal
facility: Centro Hospitalar de Trás-os -Montes e Alto-Douro, EPE - Hospital de São Pedro - Serviço de Neurologia
city: Brasov
country: Romania
facility: C.M.D.T.A. Neomed
city: Bucuresti
country: Romania
facility: Cabinet Medical Individual "Dr. Roceanu Adina Maria" -Neurologie, Neurofiziologie (EEG, EMG, PEC)
city: Campulung Muscel
country: Romania
facility: Sc Clubul Sanatatii Srl
city: Craiova; Jud. Dolj
country: Romania
facility: Spitalul Clinic de Neuropsihiatrie Craiova
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: IMAS Hospital del Mar
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
References: