Perampanel Efficacy Similar Across Patient Age, Sex in Drug-Resistant PGTCS

One-hundred and sixty two patients with PGTCS took part in the perampanel study
One-hundred and sixty two patients with PGTCS took part in the perampanel study

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.