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

June 29, 2017 updated by: Bial - Portela C S.A.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Reported Adverse Events (AE)
Time Frame: 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
throughout the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Standardized Seizure Frequency
Time Frame: 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.
8-week Baseline Period and 26-week Treatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bial - Portela C S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIA-2093-401
  • 0140BI17.MPB (Other Identifier: SCOPE)
  • 2009-012587-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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