Eslicarbazepine Acetate (BIA 2-093) as Monotherapy in Patients With Newly Diagnosed Partial-onset Seizures
Status:
Completed
Trial end date:
2018-09-11
Target enrollment:
Participant gender:
Summary
This is a Phase III, multinational, open-label, non-controlled study with subjects under
treatment in the double-blind BIA-2093-311 study (NCT01162460).
Subjects will enter the open-label extension study after the preceding double-blind study was
unblinded and they are attending their last Extension Phase Visit (EPV) of the double-blind
study.
For all subjects, the day of the last EPV of the double-blind study will also be the day of
Visit 1 for the open-label extension study. All subjects will receive Eslicarbazepine acetate
(ESL) under open-label conditions at Visit 1.
The complete study duration including treatment with ESL under open-label conditions and
follow-up is expected to last approximately 2 years (105 weeks).
In case ESL as monotherapy will achieve MA prior to the end of 2017, the study may be
discontinued prematurely within 42 days after achievement of MA.