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Abstract Details

Long-term Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4–17 years) with Focal Seizures
Epilepsy/Clinical Neurophysiology (EEG)
P9 - Poster Session 9 (12:00 PM-1:00 PM)
12-008
To analyze the long-term safety and tolerability of adjunctive eslicarbazepine acetate (ESL) in two open-label extension (OLE) studies in pediatric patients with focal seizures.

ESL is a once-daily, oral antiepileptic drug (AED) for focal (partial-onset) seizures.

Safety data from patients aged 4−17 years in OLEs of studies 2093-208 and -305 were pooled and analyzed. Studies 208-Part 1 and 305-Part 1 were randomized, double-blind, placebo-controlled studies of adjunctive ESL in pediatric patients with focal seizures refractory to treatment with
1–2 AEDs; patients could continue into uncontrolled OLEs (ESL 10−30 mg/kg/day, maximum
1200 mg/day; up to 5 years total duration).
The 1-year and post-1-year OLE safety populations comprised 337 and 177 ESL-treated patients, respectively. The overall incidences of treatment-emergent adverse events (TEAEs) with ESL were 64.1% and 52.5% during the 1-year and post-1-year OLEs, respectively. Nasopharyngitis, partial seizures, vomiting, pyrexia, headache, somnolence, and respiratory tract infection were the most frequently reported TEAEs during the 1-year OLE. The overall incidences of serious adverse events (SAEs) were 8.9% and 10.2% during the 1-year and post-1-year OLEs, respectively. Partial seizures (1.2%) and pneumonia (1.2%) were the most frequently reported SAEs during the 1-year OLE. The overall incidences of TEAEs leading to discontinuation were 4.2% and 0.6% during the 1-year and post-1-year OLEs, respectively. Partial seizures (1.5%) was the most frequently reported TEAE leading to discontinuation during the 1-year OLE. Allergic reaction TEAEs were reported in 2.4% and 0.6% of patients during the 1-year and post-1-year OLEs, respectively; there were no cases of drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, or toxic epidermal necrolysis. Hypothyroidism (1-year OLE, 0.9%; post-1-year OLE, 1.1%) and hyponatremia (1-year OLE, 0.3%; post-1-year OLE, 0.6%) were reported infrequently. 
Overall, long-term treatment with ESL was generally well tolerated in pediatric patients aged 4–17 years with focal seizures.
Authors/Disclosures
Raman Sankar, MD, PhD, FÂ鶹´«Ã½Ó³»­ (University of California Los Angeles)
PRESENTER 		Dr. Sankar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Sankar has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Dr. Sankar has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz Pharmaceuticals. Dr. Sankar has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for UCB. Dr. Sankar has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurelis. Dr. Sankar has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for SK Life Sciences. Dr. Sankar has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for LivaNova. Dr. Sankar has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eisai. Dr. Sankar has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for BioMarin. Dr. Sankar has received publishing royalties from a publication relating to health care. Dr. Sankar has received personal compensation in the range of $500-$4,999 for serving as a Grant Reviewer with NINDS, NIH.
No disclosure on file
Gregory L. Holmes, MD No disclosure on file
Jesus E. Pina-Garza, MD (Tristar Children's Specialists) Dr. Pina-Garza has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz. Dr. Pina-Garza has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurelis. Dr. Pina-Garza has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sk. Dr. Pina-Garza has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB. Dr. Pina-Garza has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Analysis Group/Acadia. Dr. Pina-Garza has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Same as consultant disclosure. Dr. Pina-Garza has received publishing royalties from a publication relating to health care.
James W. Wheless, MD, FAAP, FACP, FAES, FCNS, FÂ鶹´«Ã½Ó³»­ Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Azurity. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biocodex. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LivaNova. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoke. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for LivaNova. Dr. Wheless has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Jazz. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurelius.
Todd Grinnell, PhD Todd Grinnell, PhD has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc..
David Cantu, PhD (Xenon Pharmaceuticals Inc) Dr. Cantu has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc..
Helena Gama Helena Gama has received personal compensation for serving as an employee of Bial-Portela & Cª S.A..
Joana Moreira Joana Moreira has received personal compensation for serving as an employee of BIAL.
No disclosure on file
No disclosure on file