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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bial - Portela C S.A. Identifier:
First received: July 29, 2011
Last updated: November 29, 2013
Last verified: April 2013

This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients.

Condition Intervention Phase
Drug: Eslicarbazepine Acetate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients

Resource links provided by NLM:

Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • Evaluate the safety and tolerability of ESL as adjunctive therapy in patients aged ≥ 65 years with partial epilepsy over a 26-week treatment period [ Time Frame: 38 weeks ] [ Designated as safety issue: Yes ]
    Monitoring of Adverse Events throughout the study; Performance of Clinical Laboratory Safety Tests; Blood Pressure Rate; 12-Lead ECG; Scales for Evaluating Sedative Effects.

Secondary Outcome Measures:
  • Explore the efficacy of ESL as adjunctive therapy in patients aged ≥65 years with partial epilepsy over a 26-week treatment period [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]
    Seizures (Date, Type, Count)

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eslicarbazepine Acetate tablets (800 mg) Drug: Eslicarbazepine Acetate
ESL tablets (800 mg) QD
Other Name: Zebinix

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.


Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01422720

  Show 48 Study Locations
Sponsors and Collaborators
Bial - Portela C S.A.
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A. Identifier: NCT01422720     History of Changes
Other Study ID Numbers: BIA-2093-401, 0140BI17.MPB, 2009-012587-14
Study First Received: July 29, 2011
Last Updated: November 29, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Portugal: National Pharmacy and Medicines Institute
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Romania: National Medicines Agency

Keywords provided by Bial - Portela C S.A.:
Eslicarbazepine Acetate
Partial-onset Seizures

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on April 17, 2014