Purpose To evaluate the safety/tolerability and efficacy of eslicarbazepine acetate (ESL) as adjunctive therapy in elderly patients with partial-onset seizures (POS).
Method Phase III, multicentre, open-label, non-controlled study in patients aged ≥65 years with ≥2 POS during an 8-week baseline and treated with 1–2 antiepileptic drugs. Following baseline, patients entered a 26-week maintenance period. ESL was initiated at 400 mg once-daily and adjusted (400–1200 mg/day) based on individual response. Safety/tolerability evaluations included treatment-emergent adverse events (TEAEs), vital signs, 12-lead electrocardiogram and physical/neurological examinations. Efficacy evaluations included change in standardised seizure frequency (SSF; seizure frequency/4 weeks).
Results Of the 72 patients included, 47 (65.3%) experienced 152 TEAEs; most commonly, dizziness (12.5%), somnolence (9.7%), fatigue (8.3%), convulsion (8.3%) and hyponatraemia (8.3%). Three patients died of cardiac failure, glioblastoma multiforme and ischaemic stroke (relationship unlikely/not related). Overall, 16 (22.2%) patients discontinued due to TEAEs. Incidence of clinically significant findings was low for vital signs, electrocardiogram and physical/neurological examinations. SSF decreased from 2.9 at baseline to 1.2 during the maintenance period (median relative change: –54.1%).
Conclusion Once-daily ESL (400–1200 mg) as adjunctive therapy in elderly subjects with POS did not raise major safety concerns and was efficacious. Supported by Bial.