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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532726
• Other study ID #: BIA-2093-403
• Status: Completed
• Phase: N/A
• First received: February 10, 2012
• Last updated: January 5, 2017
• Start date: March 2012
• Est. completion date: September 2014

Study information

• Verified date: January 2017
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: National Pharmacy and Medicines Institute
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• ESL
ESL 400/800/1200 mg tablets once daily

Locations

Country	Name	City	State
Portugal	Hospital Fernando da Fonseca	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ESL retention rate	Proportion of patients on ESL treatment at the final assessment	9 months	Yes
Secondary	CGI-C score at the final assessment.	Assessment of effectivenes	9 monthss	Yes
Secondary	Changes in CGI-S score from baseline to final assessment	Assessment of effectivenes	9 months	Yes
Secondary	CGI-Efficacy Index scores at the final assessment	Assessment of effectivenes	9 months	Yes
Secondary	Proportion of patients who are responders to ESL (at least 50% reduction in seizure frequency) at the final assessment	Assessment of effectivenes	9 months	Yes
Secondary	Proportion of seizure-free patients within the 12 weeks prior to final assessment	Assessment of effectivenes	9 months	Yes
Secondary	Proportion of seizure-free patients within the 4 weeks prior to final assessment	Assessment of effectivenes	9 months	Yes
Secondary	Changes in seizure frequency for partial seizures with or without secondary generalization, from baseline to final assessment	Assessment of effectivenes	9 months	Yes
Secondary	Changes in seizure frequency for partial seizures without secondary generalization, from baseline to final assessment	Assessment of effectivenes	9 months	Yes
Secondary	Changes in seizure frequency for partial seizures with secondary generalization, from baseline to final assessment	Assessment of effectivenes	9 months	Yes
Secondary	Changes in QOLIE-10-P scores from baseline to final assessment	assessment of Quality of life	9 months	Yes
Secondary	Occurrence of AEs during the study (overall and treatment-related)	assessment of Adverse Events	9 months	No