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• W2806079983 abstract "Objective: To examine the frequency of cognitive treatment-emergent adverse events (TEAEs) in two conversion-to-ESL monotherapy trials. Background: ESL is a once-daily oral antiepileptic drug (AED) for partial-onset (focal) seizures (POS). Cognition-related TEAEs (cognitive TEAEs) were infrequent in trials of adjunctive ESL, but have not been evaluated in conversion-to-ESL monotherapy trials. Design/Methods: Data were pooled from two Phase III randomized, dose-blind, conversion-to-ESL monotherapy trials (093-045 and -046) in adults (16–70 years) with POS uncontrolled by 1–2 AEDs. Following an 8-week baseline period, eligible patients were randomized 2:1 to ESL 1600 mg or 1200 mg once daily for 18 weeks (2 weeks titration, 6 weeks baseline AED-taper, 10 weeks monotherapy). The pooled intent-to-treat (ITT) population (all randomized patients who received ≥1 ESL dose) was used for all analyses. Cognitive TEAEs and serious adverse events (SAEs) (categorized using the Medical Dictionary for Regulatory Activities, v13.1) were identified. Terms not typically regarded as cognition-related were included (FDA request). Results: The ITT population comprised 365 patients (ESL 1600 mg, n=242; ESL 1200 mg, n=123). Incidence of cognitive TEAEs was similar between doses (ESL 1600 mg, 7.0%; ESL 1200 mg, 7.3%). Memory impairment, irritability, skin laceration, and disturbance in attention were the most frequently reported cognitive TEAEs; the overall incidence of each was Conclusions: Cognitive TEAEs were infrequent in Phase III conversion-to-ESL monotherapy trials; incidences were similar between dose groups, and the majority of cognitive TEAEs were mild in severity. Study Supported by: Sunovion Pharmaceuticals Inc. Disclosure: Dr. Salpekar has received research support from Lundbeck. Dr Harden has nothing to disclose. Dr. Loring has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with NeuroPace. Dr. Loring has received personal compensation in an editorial capacity for Epilepsia and Neuropsychology Review. Dr. Loring has received research support from Medtronic. Dr. Grinnell has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc. Dr. Cantu has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc. Dr. Jung has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc. Dr. Blum has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc." @default.
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• W2806079983 date "2018-04-10" @default.
• W2806079983 modified "2023-09-28" @default.
• W2806079983 title "Analysis of Cognitive Adverse Events in Two Phase III Conversion-to-Eslicarbazepine Acetate (ESL) Monotherapy Trials (P5.277)" @default.
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