Eslicarbazepine Acetate (BIA 2-093) as Monotherapy in Patients With Newly Diagnosed Partial-onset Seizures

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.

Timeline

Start

2016-03-01

Primary completion

2018-09-11

Completion

2018-09-11

Publications

• Trinka E, Rocamora R, Chaves J, Koepp MJ, Ruegg S, Holtkamp M, Moreira J, Fonseca MM, Castilla-Fernandez G, Ikedo F. Lipid profile with eslicarbazepine acetate and carbamazepine monotherapy in adult patients with newly diagnosed focal seizures: post hoc analysis of a phase III trial and open-label extension study. Ther Adv Neurol Disord. 2023 Sep 4;16:17562864231193530. doi: 10.1177/17562864231193530. eCollection 2023.

Drugs

Indications