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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Anticonvulsants; Eslicarbazepine acetate

Criteria

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.