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

NCT01422720 | Completed Phase 3 Results

• 3 other identifiers: BIA-2093-4010140BI17.MPB2009-012587-14
• Study Type: interventional
• Target: 72
• Locations: 10 countries
• Sites: 48

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.

Conditions

Epilepsy

Keywords

Epilepsy; ESL; Eslicarbazepine Acetate; BIAL; BIA; Partial-onset Seizures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Standardized Seizure Frequency

  8-week Baseline Period and 26-week Treatment Period

Study Arms (1)

Eslicarbazepine Acetate tablets (800 mg)

EXPERIMENTAL

Drug: Eslicarbazepine Acetate

Interventions

Eslicarbazepine Acetate DRUG

ESL tablets (800 mg) QD

Also known as: Zebinix

Eslicarbazepine Acetate tablets (800 mg)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (48)

Universitätsklinik für Neurologie; Arbeitsgruppe Epileptologie

Innsbruck, Austria

Location

Universitätsklinik für Neurologie; Christian-Doppler-Klinik

Salzburg, Austria

Location

Medizinische Universitat Wien Klinik fur Neurologie

Vienna, Austria

Location

4 MHAT Sofia

Sofia, Bulgaria

Location

Diagnostic & Consultative Center "Sveta Anna" EOOD

Sofia, Bulgaria

Location

First MHAT-Sofia

Sofia, Bulgaria

Location

UMHAT "Aleksandrovska"

Sofia, Bulgaria

Location

UMHAT "Tsaritsa Yoanna -ISUL"

Sofia, Bulgaria

Location

MHAT "Prof. Stoyan Kirkovich"

Stara Zagora, Bulgaria

Location

General County Hospital Požega, Neurology department

Požega, Croatia

Location

Polyclinic for neurology and psychiatry 'Interneuron

Rijeka, Croatia

Location

Clinical Hospital Centre Split

Split, Croatia

Location

Neurologická klinika, FN u Sv. Anny

Brno, Czechia

Location

NZZ BORMED s.r.o.

Ostrava - Třebovice, Czechia

Location

Neurologická ambulance

Pilsen, Czechia

Location

Clintrial, s.r.o.

Prague, Czechia

Location

Medical Services Prague s.r.o.

Prague, Czechia

Location

Oddělení neurologie, FN Bulovka

Prague, Czechia

Location

Fakultní Thomayerova nemocnice s poliklinikou, Neurologická klinika

Praha 4 - Krč, Czechia

Location

Hôpital Gui de Chauliac, Explorations neurologiques et d'épileptologie

Montpellier, France

Location

Hôpital Central - Service de Neurologie

Nancy, France

Location

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

Paris, France

Location

Klinik für Epileptologie Universität Bonn

Bonn, Germany

Location

Zentrum Epilepsie Erlangen

Erlangen, Germany

Location

Diakonie Kork, Epilepsiezentrum

Kehl-Kork, Germany

Location

IZKS; Universitätsmedizin der Johannes-Gutenberg-Universität Mainz

Mainz, Germany

Location

Studienzentrum Dr. Stephan Arnold

München, Germany

Location

Neurologische Gemeinschaftspraxis am Seelberg

Stuttgart, Germany

Location

Universitäts- und Rehabilitationskliniken Ulm (RKU), Klinik für Neurologie

Ulm, Germany

Location

"Klinika Neurologii Rozwojowej

Gdansk, Poland

Location

Centrum Leczenia Padaczki i Migreny

Krakow, Poland

Location

Małopolskie Centrum Medyczne s.c.

Krakow, Poland

Location

Centrum Terapii Współczesnej

Lodz, Poland

Location

AIBILI - Centro de Estudos de Biodisponibildade

Coimbra, Portugal

Location

Centro Hospitalar de Lisboa Norte, EPE - Hospital de Staª Maria - Centro de Estudos Egas Moniz

Lisbon, Portugal

Location

Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, Portugal

Location

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

Viana do Castelo, Portugal

Location

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

Vila Real, Portugal

Location

C.M.D.T.A. Neomed

Brasov, Romania

Location

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

Bucharest, Romania

Location

Sc Clubul Sanatatii Srl

Campulung Muscel, Romania

Location

Spitalul Clinic de Neuropsihiatrie Craiova

Craiova; Jud. Dolj, Romania

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

IMAS Hospital del Mar

Barcelona, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Director R&D
• Organization: BIAL - Portela & Cª S.A.

clinical.trials@bial.com

+351-229866100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 24, 2011
• Study Start: April 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 7, 2017
• Results First Posted: July 18, 2014

Record last verified: 2017-06

Locations

ES (6); DE (7); PL (4); RO (4); CR (3); AU (3); FR (3); PT (5); BU (6); CZ (7)