Perampanel Efficacy Similar Across Patient Age, Sex in Drug-Resistant PGTCS
VANCOUVER, BC—The antiepileptic perampanel demonstrated similar efficacy in seizure reduction and increased responder rate across patients' age, sex or race for the treatment of primary generalized tonic-clonic seizures (PGTCS), according to a study presented at the 68th Annual AAN Meeting.
A total of 164 patients with confirmed PGTCS in idiopathic generalized epilepsy aged ≥12 years and who were receiving 1–3 concomitant antiepileptic drugs were enrolled in the study; ninety-one were female and 71 were male. The baseline period lasted 4–8 weeks, after which patients were randomized to perampanel 8mg daily or placebo. The double-blind phase included 4-week titration period, 13-week maintenance period and a 4-week follow-up.
The primary endpoint was median percent change in PGTCS frequency per 28 days (titration plus maintenance vs. baseline). A major secondary endpoint was percentage of patients achieving ≥50% reduction in PGTCS frequency (maintenance vs. baseline).
Median percentage changes in baseline PGTCS frequency with perampanel use were similar between the overall population and the specific age groups (<18 years old, -88.0%; ≥18−<65 years old, -74.4%), sexes (males, -53.3%; females, -83.0%), and race (White,-65.5%; Asian/Pacific, -79.1%). Study participants were mostly white (n=87; 53.7%) and Asian/Pacific (n=68; 42.0%), with 7% black and other races. Asian/Pacific participants had a greater level of change in PGTCS frequency than white participants, however the results were not far apart (-65.5% vs. -79.1%).
Prof Dr. med Bernhard J. Steinhoff, from the Kork Epilepsy Centre, Kehl-Kork, Germany, stated, “The PGTCS 50% responder rates per 28 days were also similar in the overall population (P=0.0019) and the subgroups of age, sex, and race."
Perampanel, a non-competitive AMPA receptor antagonist, is currently approved for adjunctive treatment of partial seizures with or without secondarily generalized seizures and for PGTCS in patients with epilepsy aged ≥12 years old. Study findings suggest that adjunctive perampanel may offer "significant clinical benefits to a diverse population of patients with inadequately controlled PGTCS in the setting of idiopathic generalized epilepsy," noted Dr. Steinhoff.
Disclosure: Dr. Steinhoff and other researchers have either received research support from, or are employees of, Eisai.