Perampanel: expanding therapeutic options for patients with medically refractory secondary generalized convulsive seizures.

Perampanel: expanding therapeutic options for patients with medically refractory secondary generalized convulsive seizures.
Acta Neurol Scand Suppl. 2013;(197):36-43
Authors: Ko D, Ramsay RE
Abstract
To evaluate the efficacy of adjunctive, once-daily perampanel against secondarily generalized (SG) seizures in three Phase III trials (studies 304, 305, and 306) and their extension (study 307). The Phase III studies enrolled patients (≥ 12 years) with uncontrolled partial-onset seizures despite treatment with 1-3 concomitant antiepileptic drugs. Patients completing the core Phase III studies were eligible for the extension study. Endpoints included median percent change in SG seizure frequency, 50% responder (proportion of patients achieving a ≥ 50% reduction in SG seizure frequency), 75% response, and seizure-freedom rates. In total, 1480 patients were randomized and treated in the three perampanel Phase III trials. At baseline, 71.9% of placebo-treated and 68.4% of perampanel-treated patients had a history of SG seizures. In the individual core Phase III studies, perampanel (4-12 mg) reduced seizure frequency and improved responder rates. Consistent with this, in pooled analyses of the Phase III data, the median percent change in SG seizure frequency was -48.6%, -62.9%, and -53.3% with perampanel 4, 8, and 12 mg, respectively, vs -19.4% with placebo; 50% responder rates were 49.3%, 60.5%, and 53.7% vs 37.0% with placebo. More perampanel-tre...

Source: Acta Neurologica Scandinavica. Supplementum - May 25, 2013 Category: Neurology Authors: Ko D, Ramsay RE Tags: Acta Neurol Scand Suppl Source Type: research