NCT01532726

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	ESL	ESL 400/800/1200 mg tablets once daily

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-02-14
• Last updated: 2017-01-06

Locations

1 site across 1 country: Portugal