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

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-93gkd4
• Date of registration: 11/03/2016
• Prospective Registration: No
• Primary sponsor: Instituto de Neurologia de Curitiba
• Public title: Efficacy and safety of Eslicarbazepine Acetate (BIA 2-093) as single therapy for patients with newly diagnosed partial-onset seizures - ESL extension study
• Scientific title: 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
• Date of first enrolment: 04/01/2016
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-93gkd4
• Study type: Intervention
• Study design: Safety and efficacy, open-label, single-arm, phase III, prospective clinical study.
• Phase: 3

Countries of recruitment

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

• Name: Anna Carolina Coimbra
• Affiliation: INC Research BR Serviços de Pesquisas Clínicas Ltda.

• Name: Anna Carolina Coimbra
• Affiliation: INC Research BR Serviços de Pesquisas Clínicas Ltda.

Key inclusion & exclusion 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 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.

Age minimum: 18Y
Age maximum:
Gender: -

Health Condition(s) or Problem(s) studied

G40.0

G40.1

Epilepsy

G40.2

Intervention(s)

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 dose level required during the preceding double-blind study. ESL dose can be increased in case of seizures up to a maximum dose of 1600 mg QD, as applicable.
Total of 341 patients, 08 of these in Brazil.

Drug

D27.505.954.427.080

Primary Outcome(s)

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

Secondary Outcome(s)

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.

Source(s) of Monetary Support

Instituto de Neurologia de Curitiba

INC Research BR Serviços de Pesquisas Clínicas Ltda.

Secondary Sponsor(s)

INC Research BR Serviços de Pesquisas Clínicas Ltda.