Abstract Details

Title Efficacy of eslicarbazepine acetate versus controlled-release carbamazepine as monotherapy in patients with newly diagnosed partial-onset seizures

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) (-)

Poster/Presentation
Number 001

Background ESL is approved by the US Food and Drug Administration (FDA) for the treatment of partial- POS as monotherapy or adjunctive therapy. ESL is approved by the European Medicines Agency as adjunctive therapy of POS in adults, and by Health Canada as adjunctive therapy of POS in patients with epilepsy who are not satisfactorily controlled with conventional therapy.

Objective

Design/Methods Patients (≥18-years) were randomized (1:1) to receive ESL or CBZ-CR in a 3-step dose-level design. Each dose-level was maintained through a 26-week Evaluation-Period (EP). The first dose-level (Dose-level A) comprised ESL 800mg QD or CBZ-CR 200mg BID. Subjects who experienced a seizure during EP increased to Dose-level B of ESL 1200mg QD or CBZ-CR 400mg BID. Subjects who had another seizure during EP at Dose-level B increased to Dose-level C of ESL 1600mg QD or CBZ-CR 600mg BID. Subjects who remained seizure-free at any dose-level continued through subsequent periods/phases. Primary-endpoint was proportion of patients with 26-week seizure freedom (non-inferiority difference margin of -12%) in the per-protocol (PP) population.

Results 815 patients were randomized (PP population; ESL n=388; CBZ-CR n=397). 71.1% of patients on ESL and 75.6% receiving CBZ-CR were seizure-free for ≥6 months at the last evaluated dose (average risk difference -4.28%, 95%CI -10.3,1.74%). The 1-year seizure-free rate at the last evaluated dose (PP population) was 64.7% on ESL group and 70.3% on CBZ-CR group (average risk difference: -5.46%; 95%CI: -11.88, 0.97%).

Conclusions In this Phase III study,ESL QD was non-inferior to CBZ-CR BID for seizure freedom rates in patients with newly diagnosed epilepsy.

Authors/Disclosures
Elinor Ben-Menachem, MD, FAAN (Dept of Clinical Neuroscience)	Dr. Ben-Menachem has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Ben-Menachem has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Arvelle. Dr. Ben-Menachem has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW Pharma. Dr. Ben-Menachem has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Acta Neurologica Scandinvica. The institution of Dr. Ben-Menachem has received research support from zogenic.
Eugen Trinka	Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bial. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Böhringer Ingelheim. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Everpharma. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Liva-Nova. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Newbridge. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GW Pharmaceuticals. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Marinus. The institution of Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Arvelle. Eugen Trinka has received research support from Austrian Science Fund (FWF). Eugen Trinka has received research support from Österreichische Nationalbank. Eugen Trinka has received research support from European Union. Eugen Trinka has received research support from GSK. Eugen Trinka has received research support from Biogen. Eugen Trinka has received research support from Eisai. Eugen Trinka has received research support from Novartis. Eugen Trinka has received research support from Red Bull. Eugen Trinka has received research support from Bayer. Eugen Trinka has received research support from UCB. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a other with Neuroconsult Ges.m.b.H..
Pedro A. Kowacs, MD, FAAN (Private Office)	Dr. Kowacs has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Patricio Soares-da-Silva	Patricio Soares-da-Silva has received personal compensation for serving as an employee of Bial - Portela & Cª S.A.. Patricio Soares-da-Silva has received personal compensation in the range of $100,000-$499,999 for serving as an officer or member of the Board of Directors for Bial - Portela & Cª S.A..

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