Adult patients with recently diagnosed partial-onset seizures MedDRA version: 18.0 Level: LLT Classification code 10065336 Term: Partial epilepsy System Organ Class: 100000004852
Conditions
Sponsors
BIAL - Portela & Ca, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the extension study, subjects must fulfill all of the following at Visit 1 (Day 1, start of the open-label extension study): 1. Participated in the preceding double-blind study and were still ongoing at the time of unblinding. 2. Have signed informed consent before undergoing any activities related to the open-label extension study. 3. Demonstrated cooperation and willingness to complete all aspects of the study. 4. Female subjects without childbearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, or complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative serum ß-human chorionic gonadotropin (hCG) test and sexually active females must be using a medically acceptable effective non-hormonal method of contraception for the duration of the study and until the Post-study Visit (PSV). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 279 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
Exclusion criteria: Subjects having any of the following at Visit 1 are to be excluded from the study: 1. Excluded from the double-blind study due to seizure in the Maintenance or Extension Phase, or at dose level C (either CBZ-CR or ESL), or discontinued prematurely due to any other reason in the double-blind study. 2. Presence of any major protocol violation during the double-blind study which may have an impact on the compliance during this extension study. 3. Judged clinically to have a suicidal risk in the opinion of the investigator based upon a clinical interview and the Columbia Suicide-Severity Rating Scale (C-SSRS). 4. Occurrence of an adverse event (AE) indicating a suspected presence of atrioventricular block (2nd degree and above) or of any other AEs during the double-blind study which are judged by the investigator as contraindicative to further participation in the open-label extension study. 5. Events of alcohol, drug, or medication abuse during the preceding double-blind study. 6. Relevant clinical laboratory abnormalities (e.g. sodium 2 x the upper limit of normal, white blood cell count <3000 cells/mm3) (as reported at Visit 1). 7. Pregnancy or lactating. 8. Any oth r condition or circumstance that, in the opinion of the investigator, could compromise the subject’s ability to comply with the extension-study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm maintenance of efficacy of eslicarbazepine acetate (ESL, 800 mg to 1600 mg once daily [QD]) monotherapy during long-term treatment in adults (=18 years) with recently diagnosed epilepsy experiencing partial-onset seizures.;Secondary Objective: 1. To further demonstrate the efficacy of ESL in subjects switching from carbamazepine controlled-release (CBZ-CR) treatment. 2. To demonstrate the safety of ESL in subjects switching from CBZ-CR treatment and in subjects already treated with ESL monotherapy for at least one year (i.e. during long-term treatment). ;Primary end point(s): Time to treatment failure, defined as time from start of open-label ESL treatment at Visit 1 until withdrawal due to AE or due to lack of efficacy (i.e. inadequate seizure control).;Timepoint(s) of evaluation of this end point: at least 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Treatment retention time (overall, i.e. including previously CBZ-CR treated subjects, and by reason) at the last evaluated dose during open-label treatment, where treatment retention time is defined as the time from start of the extension study until withdrawal of ESL due to AEs or due to lack of efficacy (i.e. inadequate seizure control). • Time to withdrawal for any reason at the last evaluated dose. • Changes in quality of life assessed using the QOLIE-31. • Changes in overall treatment satisfaction as assessed on a 4-point scale. ;Timepoint(s) of evaluation of this end point: at least 1 year | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Ukraine, United Kingdom
Contacts
Public Contactsponsor
BIAL - Portela & Ca, S.A.
Outcome results
None listed