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

BIAL

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Eslicarbazepine Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01422720

0140BI17.MPB (Other Identifier)

BIA-2093-401

2009-012587-14 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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;
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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Eslicarbazepine Acetate tablets (800 mg)

Experimental group

Treatment:

Drug: Eslicarbazepine Acetate