Hospital Fernando da Fonseca
Lisbon, Lisbon District, 2720-276, Portugal
NCT Number: NCT01532726
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.
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Notify Me18 year and older
All sexes
Observational
Lisbon, Lisbon District, 2720-276, Portugal
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ESL 400/800/1200 mg tablets once daily
Other names: Zebinix
Time frame: 9 months
Proportion of patients on ESL treatment at the final assessment
Time frame: 9 monthss
Assessment of effectivenes
Time frame: 9 months
Assessment of effectivenes
Time frame: 9 months
Assessment of effectivenes
Time frame: 9 months
Assessment of effectivenes
Time frame: 9 months
Assessment of effectivenes
Time frame: 9 months
Assessment of effectivenes
Time frame: 9 months
Assessment of effectivenes
Time frame: 9 months
Assessment of effectivenes
Time frame: 9 months
Assessment of effectivenes
Time frame: 9 months
assessment of Quality of life
Time frame: 9 months
assessment of Adverse Events
Bial - Portela C S.A.
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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