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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01422720
Recruitment Status : Completed
First Posted : August 24, 2011
Results First Posted : July 18, 2014
Last Update Posted : August 7, 2017
Information provided by (Responsible Party):
Bial - Portela C S.A.

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Eslicarbazepine Acetate Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients
Study Start Date : April 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Experimental: Eslicarbazepine Acetate tablets (800 mg) Drug: Eslicarbazepine Acetate
ESL tablets (800 mg) QD
Other Name: Zebinix

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01422720

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Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A. Identifier: NCT01422720    
Other Study ID Numbers: BIA-2093-401
0140BI17.MPB ( Other Identifier: SCOPE )
2009-012587-14 ( EudraCT Number )
First Posted: August 24, 2011    Key Record Dates
Results First Posted: July 18, 2014
Last Update Posted: August 7, 2017
Last Verified: June 2017
Keywords provided by Bial - Portela C S.A.:
Eslicarbazepine Acetate
Partial-onset Seizures
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Eslicarbazepine acetate
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action