Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients
Overview
- Phase
- Phase 3
- Intervention
- Eslicarbazepine Acetate
- Conditions
- Epilepsy
- Sponsor
- Bial - Portela C S.A.
- Enrollment
- 72
- Locations
- 48
- Primary Endpoint
- Number of Subjects With Reported Adverse Events (AE)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent form;
- •Of age 65 years or older;
- •A documented diagnosis of epilepsy for at least 12 months,
- •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;
- •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);
- •Willing and able to comply with all trial requirements, in the judgment of the investigator;
- •At least 2 partial-onset seizures (documented in the diary) per 4 weeks during the 8-week baseline period;
- •Satisfactorily complied with the study requirements during the baseline period
Exclusion Criteria
- •Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures);
- •Primarily generalised seizures;
- •Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
- •Occurrence of seizures too close to count accurately;
- •History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening;
- •Seizures of non-epileptic origin;
- •Major psychiatric disorders;
- •History of suicide attempt;
- •Currently treated with oxcarbazepine;
- •Previous use of ESL or participation in a clinical study with ESL;
Arms & Interventions
Eslicarbazepine Acetate tablets (800 mg)
Intervention: Eslicarbazepine Acetate
Outcomes
Primary Outcomes
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 Outcomes
- Change From Baseline in Standardized Seizure Frequency(8-week Baseline Period and 26-week Treatment Period)