Abstracts

Rationale:
In the US and Korea, perampanel is approved for POS (adjunctive and monotherapy) in patients aged ≥ 4 years, and adjunctive treatment of primary generalized tonic-clonic seizures in patients aged ≥ 12 (≥ 7, Korea) years. Convulsive seizures, including secondarily generalized seizures (SGS), are often refractory and have been associated with increased mortality rates from sudden unexpected death in epilepsy and other seizure-related complications. Therefore, it is particularly important to achieve seizure control in patients with convulsive seizures. Here, we present results of a post hoc subgroup analysis from the FAME study (Fycompa as first Add-on to Monotherapy in patients with Epilepsy; Study 412, NCT02726074; South Korea) to assess the rate of seizure freedom (100% responder) in patients with SGS by maintenance dose of perampanel.
Method:
Patients in FAME were aged ≥ 12 years with POS with or without SGS and had failed on antiepileptic drug monotherapy. Perampanel was up-titrated to ≤ 12 mg/day (12 weeks), followed by a 24-week Maintenance Period. For this analysis, patients with SGS were stratified by maintenance perampanel dose. Assessments included 50% and 75% responder rates, seizure-freedom rates (Full Analysis Set), and incidence of treatment-emergent adverse events (TEAEs).
Results:
The Full Analysis Set included a total of 85 patients with POS (with or without SGS). Of these, 16 (18.8%) patients reported POS with SGS. Overall, 14/16 (87.5%) patients with SGS experienced a ≥ 50% or ≥ 75% reduction in seizure frequency from baseline. Of these 14 patients, 7 (50.0%) patients each were receiving a maintenance perampanel dose of 4 mg/day or 6 mg/day. Seizure freedom in patients with SGS was achieved by 12/16 (75.0%) patients. Seven of the 12 seizure-free patients (58.3%) were receiving perampanel at a maintenance dose of 4 mg/day and 5 (41.7%) were receiving perampanel at a maintenance dose of 6 mg/day. Thirteen patients (81.3%) reported a TEAE (n=8 on 4 mg/day and n=5 on 6 mg/day); the most common was dizziness (50.0% [n=8/16]). Three patients reported a serious AE (SAE); 1 SAE lead to discontinuation (suicide attempt with 4 mg/day perampanel but was not considered treatment related).
Conclusion:
The majority of patients with SGS achieved seizure freedom with perampanel at a maintenance dose of 4 or 6 mg/day, with favorable tolerability. Despite the small sample size, these results suggest that convulsive seizure freedom can be achieved with the lower perampanel doses when perampanel is received as an early-line treatment.
Funding:
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Funding:
: Eisai Korea Inc.