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Abstract Details

Effect of Concomitant Enzyme-Inducing Antiepileptic Drugs (EIAEDs) on the Efficacy and Safety of Adjunctive Perampanel 4 mg/day in Patients Aged =12 Years with Partial-Onset Seizures in Asia-Pacific Study 335
Epilepsy/Clinical Neurophysiology (EEG)
P8 - Poster Session 8 (8:00 AM-9:00 AM)
12-010
A post hoc analysis to assess efficacy and safety of perampanel 4 mg/day in patients from Asia-Pacific Study 335 stratified by concomitant EIAEDs at baseline.
Perampanel is a once-daily oral antiepileptic drug (AED) for partial-onset seizures (POS) and primary generalized tonic-clonic seizures. Study 335 (NCT01618695) was a multicenter, randomized, double-blind, placebo-controlled, Phase III study of adjunctive perampanel (4/8/12 mg) in patients (aged ≥12 years) from Asia-Pacific region with refractory POS (with/without secondarily generalized seizures [SGS]) receiving 1–3 concomitant AEDs (including ≤1 EIAED [carbamazepine/phenytoin/oxcarbazepine]).
Study 335 comprised a 19-week Double-blind Period (6-week Titration; 13-week Maintenance). In this analysis, patients receiving perampanel 4 mg/day or placebo were stratified by presence/absence of EIAEDs at baseline. Efficacy assessments included median change in seizure frequency/28 days and 50% responder rates. Safety assessments included monitoring of treatment-emergent adverse events (TEAEs).

Of 704 patients in the intent-to-treat population, 174 were randomized to perampanel 4 mg/day (n=118/n=56 with EIAEDs/non-EIAEDs) and 175 to placebo (n=119/n=56, with EIAEDs/non-EIAEDs).

Median reductions in seizure frequency/28 days were: 12.4% and 10.0% for patients receiving perampanel and placebo with EIAEDs (median [95% confidence interval (CI)] difference perampanel vs placebo, 0.6% [-10.2, 11.4]); and 30.9% and 13.2% in patients receiving perampanel and placebo with non-EIAEDs (median [95% CI] difference perampanel vs placebo, 14.8% [-3.3, 32.6]). Fifty-percent responder rates were 16.1% (n=19; perampanel) and 17.6% (n=21; placebo) with EIAEDs, and 37.5% (n=21; perampanel) and 23.2% (n=13; placebo) with non-EIAEDs.

TEAEs occurred in 64.2% (perampanel) and 62.5% (placebo) of patients with EIAEDs, and 78.6% (perampanel) and 75.0% (placebo) of patients with non-EIAEDs; most were mild-to-moderate.

Based on this analysis, adjunctive perampanel 4 mg/day is effective in patients aged ≥12 years with refractory POS (with/without SGS), from the Asia-Pacific region, however, a higher dose may need to be considered in patients taking EIAEDs.

Funding: Eisai Inc.
Authors/Disclosures

PRESENTER 		No disclosure on file
Amitabh Dash, MD Amitabh Dash, MD has nothing to disclose.
No disclosure on file
No disclosure on file
Manoj Malhotra, MD Dr. Malhotra has received personal compensation for serving as an employee of Eisai.