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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Eslicarbazepine Acetate

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eslicarbazepine Acetate tablets (800 mg)	Drug: Eslicarbazepine Acetate; ESL tablets (800 mg) QD; Other Names: Zebinix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	throughout the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Standardized Seizure Frequency	Absolute and relative changes from baseline of seizure frequency standardised to a frequency per 4 weeks.	8-week Baseline Period and 26-week Treatment Period

Collaborators and Investigators

• Sponsor: Bial - Portela C S.A.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 29, 2011
• First Submitted That Met QC Criteria: August 23, 2011
• First Posted (Estimate): August 24, 2011

Study Record Updates

• Last Update Posted (Actual): August 7, 2017
• Last Update Submitted That Met QC Criteria: June 29, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Epilepsy; ESL; BIA; Eslicarbazepine Acetate; BIAL; Partial-onset Seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Eslicarbazepine acetate
• Other Study ID Numbers: BIA-2093-401; 0140BI17.MPB (Other Identifier: SCOPE); 2009-012587-14 (EudraCT Number)