Abstract Details

Title Safety and tolerability of eslicarbazepine acetate as monotherapy in patients with newly diagnosed partial-onset seizures

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) (-)

Poster/Presentation
Number 002

Background ESL is approved by the FDA for the treatment of POS as monotherapy or adjunctive therapy. ESL is approved by the EMA 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 either ESL or CBZ-CR in a 3-step dose-level design. Each dose-level was to be maintained through a 26-week Evaluation-Period (EP) and increased to the next dose-level in the event of seizure during EP. Dose-level A was ESL 800mg/day or CBZ-CR 400mg/day, Dose-level B, ESL 1200mg/day or CBZ-CR 800mg/day, and C was ESL 1600mg/day or CBZ-CR 1200mg/day. Subjects who remained seizure-free at any dose-level continued through subsequent periods/phases. Safety assessments included treatment-emergent adverse events (TEAEs), laboratory tests, physical/neurological examinations, electrocardiogram, C-SSRS and BL-VAS.

Results From the 815 randomized patients, 813 were included in the safety analyses (ESL, 401; CBZ-CR, 412). Incidences rates were similar, although slightly higher in patients receiving CBZ-CR for TEAEs, possibly-related TEAEs, serious possibly-related TEAEs, and TEAEs leading to withdrawal. The most frequently reported possibly-related TEAEs were (ESL; CBZ): headache (8.0%; 6.3%), dizziness (9.7%; 7.5%), nausea (6.0%; 7.0%), fatigue (5.0%; 5.3%), somnolence (7.0%; 8.0%) and increased gamma-glutamyltransferase (2.7%; 12.6%). Most TEAEs were of mild intensity. TEAEs resulting in treatment discontinuation were nausea, fatigue, hypersensitivity, convulsion, dizziness, headache, allergic dermatitis and rash. One patient (CBZ-CR group) discontinued due to hyponatremia.

Conclusions Once-daily ESL monotherapy demonstrated favorable safety in the study population. No new or unexpected safety findings emerged, compared with the adjunctive studies.

Authors/Disclosures
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.
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..
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.
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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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