Open Label ESL Extension (FROM IMPORT)
Research type
Research Study
Full 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 STUDY — OPEN-LABEL ESL EXTENSION —
IRAS ID
188216
Contact name
José Francisco Rocha
Contact email
Sponsor organisation
BIAL - Portela & Ca, S.A.
Eudract number
2015-001243-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
This study aims to ensure continuation of the best care for patients who demonstrated a good response to the double-blind treatment of the preceding study until marketing authorization (MA) of ESL as monotherapy.
Approximately 300 subjects are expected to enter the open-label extension study in approximately 27 countries worldwide.
For all subjects participating in this study, the last Extension Phase Visit (EPV) of the double-blind study will also be Visit 1 for this study. Subjects will be asked if they are willing to continue in an open-label extension to receive treatment with ESL for up to additional 2 years. In case marketing authorization (MA) of ESL as monotherapy will be achieved prior to the end of 2017, the study may be discontinued prematurely within 42 days after achievement of MA.
For subjects not willing to enter the study, IMP from the double-blind study (CBZ-CR or ESL) is to be discontinued according to the down-titration scheme in the protocol and commercially available antiepileptic drug (AED) is to be introduced to investigator`s discretion
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0293
Date of REC Opinion
2 Nov 2015
REC opinion
Further Information Favourable Opinion