Eslicarbazepine Acetate as Add-On Treatment to One Baseline Antiepileptic Drug (ESLADOBA)

A Non-Interventional, Prospective Study to Assess Seizure Control and Tolerability of Eslicarbazepine Acetate as Adjunctive Therapy to One Baseline Antiepileptic Drug, in Adults With Partial-Onset Seizures With or Without Secondary Generalization

This is a multicenter, non-interventional, prospective study. The observation period comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients with partial-onset epilepsy not sufficiently controlled with one AED, until the first visit that occurs between 6 and 9 months of follow-up. The observation period will end after 9 months of follow-up even if the final assessment is not performed.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: ESL

Detailed Description

To ensure non-interventional status, the neurologist's decision that it is in the patient's best interest to be prescribed with adjunctive ESL has to be made before and independently of his/her decision to include the patient in the study. At all circumstances during the study the patients will be treated and followed according to routine clinical practice. ESL and concomitant medication should be managed by the neurologist according to the respective Summary of Product Characteristics (SPC).In order to reflect real-life practice and to ensure the observational nature of this study, no fixed time-points for study assessment were defined. Intermediate follow-up data will be collected whenever a patient attends to the study's neurologist consultation.

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal, 2720-276
    • Hospital Fernando da Fonseca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with Partial-Onset Seizures With or Without Secondary Generalization

Description

Inclusion Criteria:

• Male or female outpatient, 18 years or older;
• The patient has an established diagnosis of epilepsy and has experienced at least one partial-onset seizure, with or without secondary generalization, within four weeks prior to initiation of adjunctive ESL;
• The patient is not sufficiently controlled on a current antiepileptic monotherapy and, in the neurologist clinical judgment, it is in the patient's best interest to be prescribed with adjunctive ESL;
• The neurologist's decision to prescribe ESL has been made before and independently of his/her decision to include the patient in this study;
• The patient's treatment is in accordance with the SPC of ESL;
• Written informed consent from the patient (or legally acceptable representative, if the subject is unable to provide informed consent).

Exclusion Criteria:

• Known hypersensitivity to the active substance, carboxamide derivatives (e.g. oxcarbazepine or carbamazepine) or to any of its excipients;
• Patient with 2nd or 3rd degree atrioventricular block;
• Patient treated with an experimental drug within four weeks prior to the introduction of ESL;
• Female patient who is pregnant, lactating, or who is planning to become pregnant during the study period;
• Patient starting ESL outside the approved SPC at enrolment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eslicarbazepine Acetate (ESL); ESL and concomitant medication should be managed by the neurologist according to the respective SPC.Summary of Product Characteristics	Drug: ESL; ESL 400/800/1200 mg tablets once daily; Other Names: Zebinix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ESL retention rate	Proportion of patients on ESL treatment at the final assessment	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGI-C score at the final assessment.	Assessment of effectivenes	9 monthss
Changes in CGI-S score from baseline to final assessment	Assessment of effectivenes	9 months
CGI-Efficacy Index scores at the final assessment	Assessment of effectivenes	9 months
Proportion of patients who are responders to ESL (at least 50% reduction in seizure frequency) at the final assessment	Assessment of effectivenes	9 months
Proportion of seizure-free patients within the 12 weeks prior to final assessment	Assessment of effectivenes	9 months
Proportion of seizure-free patients within the 4 weeks prior to final assessment	Assessment of effectivenes	9 months
Changes in seizure frequency for partial seizures with or without secondary generalization, from baseline to final assessment	Assessment of effectivenes	9 months
Changes in seizure frequency for partial seizures without secondary generalization, from baseline to final assessment	Assessment of effectivenes	9 months
Changes in seizure frequency for partial seizures with secondary generalization, from baseline to final assessment	Assessment of effectivenes	9 months
Changes in QOLIE-10-P scores from baseline to final assessment	assessment of Quality of life	9 months
Occurrence of AEs during the study (overall and treatment-related)	assessment of Adverse Events	9 months

Collaborators and Investigators

• Sponsor: Bial - Portela C S.A.
• Investigators: Principal Investigator: João Chaves, MD, Centro Hospitalar do Porto

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (Estimate): February 14, 2012

Study Record Updates

• Last Update Posted (Estimate): January 6, 2017
• Last Update Submitted That Met QC Criteria: January 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Partial-Onset Seizures; ESL; Eslicarbazepine Acetate; BIA 2-093; BIAL
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Eslicarbazepine acetate
• Other Study ID Numbers: BIA-2093-403