Abstract Details

Title Analysis of Allergic Reactions in Clinical Trials of Eslicarbazepine Acetate in Children (Aged 4–17 Years) with Focal Seizures

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 6-022

Objective

To evaluate the occurrence of allergic reactions in clinical trials of eslicarbazepine acetate (ESL) for focal (partial-onset) seizures in children.

Background

ESL is a once-daily oral antiepileptic drug (AED) for focal seizures. Allergic reactions are a recognized adverse effect of AED treatment and were reported during clinical trials of ESL in adults.

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 partial 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. All patients could continue into uncontrolled, open-label extension (OLE) studies of ESL. We evaluated incidences of allergic reaction events.

Results The controlled safety population included 362 patients (ESL n = 202; placebo n = 160); 337 continued into the OLEs. During the controlled studies, allergic reactions occurred in 5.0% of patients taking ESL and 1.3% taking placebo; the majority were mild to moderate in severity. The most common allergic reaction events were allergic dermatitis (ESL 3.0%; placebo 0) and rash (ESL 1.0%; placebo 1.3%). There was one case of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) with ESL during the controlled studies, and no cases of Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN). Nine patients had allergic reactions during the uncontrolled OLEs.

Conclusions Allergic reactions occurred in 5% of children aged 4–17 years during double-blind treatment with adjunctive ESL for focal seizures, and were generally non-serious. There was one case of DRESS, and no cases of SJS or TEN.

Authors/Disclosures
Trevor J. Resnick, MD PRESENTER	Dr. Resnick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Dr. Resnick has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for supernus. Dr. Resnick has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sunovion.
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
Helena Gama	Helena Gama has received personal compensation for serving as an employee of Bial-Portela & Cª S.A..
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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