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COMPLETEDPHASE3

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

NCT01422720•Bial - Portela C S.A.

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

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

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;
+7 more criteria

Locations (48)

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

Key Dates

Start Date

April 1, 2010

Primary Completion Date

September 1, 2013

Completion Date

September 1, 2013

Last Updated

August 7, 2017

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

Eslicarbazepine Acetate

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

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