Abstract Details

Title Analysis of Hematological and Serum Chemistry Abnormalities in Clinical Trials of Adjunctive Eslicarbazepine Acetate 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 6-010

Objective To evaluate the occurrence of cytopenia treatment-emergent adverse events (TEAEs) and hematology and serum chemistry abnormalities in clinical trials of eslicarbazepine acetate (ESL) for focal (partial-onset) seizures in children.

Background ESL is a once-daily oral antiepileptic drug for focal seizures. Although rare, hematological adverse events have been reported in adults using ESL.

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 extensions (OLEs). Incidences of cytopenia TEAEs were calculated and laboratory samples were evaluated for hematology and serum chemistry abnormalities.

Results The controlled safety population included 362 patients (ESL n = 202; placebo n = 160); 337 continued into OLEs. Cytopenia TEAEs occurred during controlled studies: ESL n = 4 (2.0%) (neutropenia 1.5%; anemia 0.5%); placebo n = 0. Cytopenia TEAEs also occurred with ESL during uncontrolled OLEs: n = 3 (pancytopenia n = 2; anemia n = 1). There were no clinically significant changes between baseline and highest/lowest on-treatment values for any hematology or serum chemistry parameter. Some treatment-emergent potentially clinically significant laboratory parameters (low bicarbonate, low/high phosphate, high monocytes, high potassium) each occurred in >5% of patients taking ESL; incidences were similar with ESL versus placebo and across study periods.

Conclusions Cytopenia TEAEs occurred infrequently during controlled and uncontrolled use of adjunctive ESL for focal seizures in children aged 4–17 years. In addition, there were no clinically significant changes between baseline and highest/lowest on-treatment values for any hematology or serum chemistry parameter.

Authors/Disclosures
Prakash Kotagal, MD, MBBS, FAAN (Cleveland Clinic Foundation) PRESENTER	No disclosure on file
Tobias Loddenkemper, MD, FAAN	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
Joana Moreira	Joana Moreira 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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