Abstract Details

Title Relationship Between Adverse Event Incidence and Eslicarbazepine Acetate (ESL) Dose Across Weight Groups in Clinical Trials of Adjunctive ESL in Children (Aged 4–17 Years) with Focal Seizures

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 6-013

Objective To evaluate the occurrence of treatment-emergent adverse events (TEAEs) in clinical trials of eslicarbazepine acetate (ESL) for focal (partial-onset) seizures in children, according to ESL dose across weight groups.

Background

ESL is a once-daily oral antiepileptic drug for focal seizures.

Design/Methods This post-hoc analysis evaluated safety and tolerability data pooled from two randomized, double-blind, placebo-controlled trials (BIA-2093-208 and -305) of adjunctive ESL in pediatric patients (4–17 years) with refractory focal seizures. In Study 208-Part 1, patients (6–16 years) received ESL (target dose 30 mg/kg/day) for 12 weeks. In Study 305-Part 1, patients (2–18 years) received ESL (target dose 20 mg/kg/day) for 18 weeks. TEAEs were evaluated according to modal daily ESL dose (below low, low, high, and above high) and weight (11–21 kg, 22–31 kg, 32–38 kg, and >38 kg).

Results The safety population included 362 subjects (ESL n = 202; placebo n = 160); median ages were 11 (ESL) and 10 (placebo) years. The overall incidence of TEAEs was generally higher with ESL (50–100% across modal daily dose groups) versus placebo (63–69%), but there was no dose response in any weight group. There was also no dose response for headache, somnolence, vomiting, nasopharyngitis, pyrexia, or partial seizures, in any weight group. In addition, overall TEAE incidence, as well as incidences of the most common TEAEs, did not appear to vary with subject weight in any modal dosing category.

Conclusions Tolerability was assessed according to modal daily ESL dose category in four groups defined by patient weight. Neither overall TEAE incidence, nor incidences of the most common individual TEAEs, increased with increasing modal daily ESL dose in clinical trials of ESL for focal seizures in children aged 4–17 years.

Authors/Disclosures
Jesus E. Pina-Garza, MD (Tristar Children's Specialists) PRESENTER	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.
Steven M. Wolf, MD (Pediatric Neurology Boston Children's He)	Dr. Wolf has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Assertio. Dr. Wolf has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for LivaNova. Dr. Wolf has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurilis. Dr. Wolf has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB. Dr. Wolf has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for MOnteris . Dr. Wolf has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Marinus . The institution of Dr. Wolf has received research support from Neuropace. The institution of Dr. Wolf has received research support from Eisai. The institution of Dr. Wolf has received research support from Aguestive. The institution of Dr. Wolf has received research support from Neurilis . The institution of Dr. Wolf has received research support from UCB. The institution of Dr. Wolf has received research support from SKLife . The institution of Dr. Wolf has received research support from Longboard . The institution of Dr. Wolf has received research support from Takeda. The institution of Dr. Wolf has received research support from biohaven. The institution of Dr. Wolf has received research support from Assertio. Dr. Wolf has received intellectual property interests from a discovery or technology relating to health care. Dr. Wolf has received publishing royalties from a publication relating to health care.
Patricia E. McGoldrick, NP	No disclosure on file
Todd Grinnell, PhD	Todd Grinnell, PhD has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc..
David Cantu, PhD (Sunovion Pharmaceuticals Inc.)	Dr. Cantu has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc..
	No disclosure on file
	No disclosure on file
Fabio Ikedo	Fabio Ikedo has received personal compensation for serving as an employee of Bial.
David E. Blum, MD	Dr. Blum has received personal compensation for serving as an employee of Neurona Therapeutics. Dr. Blum has stock in Neurona Therapeutics.

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