Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients

NCT ID: NCT01422720

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-09-30

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.

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eslicarbazepine Acetate tablets (800 mg)

Group Type: EXPERIMENTAL

Eslicarbazepine Acetate

Intervention Type: DRUG

ESL tablets (800 mg) QD

Interventions

Eslicarbazepine Acetate

ESL tablets (800 mg) QD

Intervention Type: DRUG

Other Intervention Names

Zebinix

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinik für Neurologie; Arbeitsgruppe Epileptologie

Innsbruck, , Austria

Universitätsklinik für Neurologie; Christian-Doppler-Klinik

Salzburg, , Austria

Medizinische Universitat Wien Klinik fur Neurologie

Vienna, , Austria

4 MHAT Sofia

Sofia, , Bulgaria

Diagnostic & Consultative Center "Sveta Anna" EOOD

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

Pilsen, , Czechia

Clintrial, s.r.o.

Prague, , Czechia

Medical Services Prague s.r.o.

Prague, , Czechia

Oddělení neurologie, FN Bulovka

Prague, , Czechia

Fakultní Thomayerova nemocnice s poliklinikou, Neurologická klinika

Praha 4 - Krč, , Czechia

Hôpital Gui de Chauliac, Explorations neurologiques et d'épileptologie

Montpellier, , France

Hôpital Central - Service de Neurologie

Nancy, , France

Groupement Hospitalier Universitaire Est, Pitié-Salpétrière; Clinique des Maladies du Système Nerveux

Paris, , France

Klinik für Epileptologie Universität Bonn

Bonn, , Germany

Zentrum Epilepsie Erlangen

Erlangen, , 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

Gdansk, , Poland

Centrum Leczenia Padaczki i Migreny

Krakow, , Poland

Małopolskie Centrum Medyczne s.c.

Krakow, , 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

Unidade Local de Saúde de Alto Minho, EPE - Hospital de Santa Luzia - Serviço de Neurologi

Viana do Castelo, , Portugal

Centro Hospitalar de Trás-os -Montes e Alto-Douro, EPE - Hospital de São Pedro - Serviço de Neurologia

Vila Real, , Portugal

C.M.D.T.A. Neomed

Brasov, , Romania

Cabinet Medical Individual "Dr. Roceanu Adina Maria" -Neurologie, Neurofiziologie (EEG, EMG, PEC)

Bucharest, , Romania

Sc Clubul Sanatatii Srl

Campulung Muscel, , Romania

Spitalul Clinic de Neuropsihiatrie Craiova

Craiova; Jud. Dolj, , Romania

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

IMAS Hospital del Mar

Barcelona, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Countries

Austria; Bulgaria; Croatia; Czechia; France; Germany; Poland; Portugal; Romania; Spain

Other Identifiers

0140BI17.MPB

Identifier Type: OTHER

Identifier Source: secondary_id

2009-012587-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BIA-2093-401

Identifier Type: -

Identifier Source: org_study_id