Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Eslicarbazepine Acetate
Intervention description: ESL tablets (800 mg) QD
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Epilepsy; ESL; Eslicarbazepine Acetate; BIAL; BIA; Partial-onset Seizures

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.
    

Eligibility 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.