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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01422720
First received: July 29, 2011
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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
Epilepsy
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:
  • Number of Subjects With Reported Adverse Events (AE) [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

    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 with at least one severe TEAE


Secondary Outcome Measures:
  • Change From Baseline in Standardized Seizure Frequency [ Time Frame: 8-week Baseline Period and 26-week Treatment Period ] [ Designated as safety issue: No ]
    Absolute and relative changes from baseline of seizure frequency standardised to a frequency per 4 weeks.


Enrollment: 72
Study Start Date: April 2010
Study Completion Date: September 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.

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov 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.
ClinicalTrials.gov Identifier: NCT01422720     History of Changes
Other Study ID Numbers: BIA-2093-401, 0140BI17.MPB, 2009-012587-14
Study First Received: July 29, 2011
Results First Received: May 9, 2014
Last Updated: July 17, 2014
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.:
Epilepsy
ESL
Eslicarbazepine Acetate
BIAL
BIA
Partial-onset Seizures

Additional relevant MeSH terms:
Epilepsy
Seizures
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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014