Efficacy and safety of Eslicarbazepine Acetate (BIA 2-093) as single therapy for patients with newly diagnosed partial-onset seizures - ESL extension study

Efficacy and safety of Eslicarbazepine Acetate (BIA 2-093) as monotherapy for patients with newly diagnosed partial-onset seizures: a double-blind, randomized, active-controlled, parallel-group, multicenter clinical trial - open-label ESL extension

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-93gkd4

Enrollment

Unknown

Registered

2016-03-11

Start date

2016-01-04

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Interventions

Single group with oral administration of ESL, 800 mg divisible tablets, once daily. The first target dose will be either 800 mg QD, 1200 mg QD or 1600 mg QD, depending on and equal/equivalent to the d

Drug

D27.505.954.427.080

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participation in the preceding double-blind study and still ongoing at the time of unblinding; informed consent signature; cooperation and willingness to complete all aspects of the study.

Exclusion criteria

Exclusion criteria: Exclusion from the double-blind study; clinical evaluation of suicidal risk; occurrence of an adverse event; events of alcohol, drug, or medication abuse; relevant clinical laboratory abnormalities; pregnancy or lactating.

Design outcomes

Primary

Measure	Time frame
Time to treatment failure for subjects already treated with ESL during the double-blind study, through Kaplan-Meier method, for survival probability estimation.	—

Secondary

Measure	Time frame
Treatment retention time at the last evaluated dose during open-label treatment, through descriptive statistics; Time to withdrawal for any reason at the last evaluated dose, through descriptive statistics; Changes in quality of life assessed using the QOLIE-31, through descriptive statistics; Changes in overall treatment satisfaction, through descriptive statistics.	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, India, Israel, Italy, Latvia, Lithuania, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Ukraine, United Kingdom

Contacts

Public ContactAnna Coimbra

INC Research BR Serviços de Pesquisas Clínicas Ltda.

annacarolina.coimbra@incresearch.com+55 (21) 3553 9763

Outcome results

None listed

Source: REBEC (via WHO ICTRP)