Efficacy and Safety of Adjunctive Perampanel for the Treatment of Primary Generalized Tonic-Clonic Seizures (PGTCS): Analysis of Adult, Adolescent, and Pediatric Populations (Studies 332, 311)
Abstract number :
2.21
Submission category :
7. Antiepileptic Drugs / 7B. Clinical Trials
Year :
2019
Submission ID :
2421655
Source :
www.aesnet.org
Presentation date :
12/8/2019 4:04:48 PM
Published date :
Nov 25, 2019, 12:14 PM
Authors :
#N/A; Gregory L. Krauss, Johns Hopkins Hospital, Baltimore, MD, USA; Anna Patten, Eisai Ltd., Hatfield, Hertfordshire, UK; Manoj Malhotra, Eisai Inc., Woodcliff Lake, NJ, USA; Stella L. Ngo, Eisai Inc., Woodcliff Lake, NJ, USA
Rationale: Perampanel is a once-daily oral anti-seizure drug (ASD) for partial-onset seizures (POS) and PGTCS. Study 332 (NCT01393743) was a Phase III, randomized, double-blind, placebo-controlled study of adjunctive perampanel (target dose: 8 mg/day) in patients aged >=12 years with PGTCS of idiopathic generalized epilepsy. Study 311 (NCT02849626) was a multicenter, open-label, single-arm study of perampanel oral suspension (0.5 mg/mL; up to 12 mg/day without enzyme-inducing ASDs [EIASDs] or up to 16 mg/day with EIASDs) in patients aged 4 to <12 years with POS (with/without secondarily generalized seizures) or PGTCS. Here, we present efficacy and safety data from these two studies across pediatric, adolescent, and adult patients with PGTCS. Methods: The design of Study 332 has been published previously (French JA et al. Neurology 2015;85:950--7). The Core Study of Study 311 comprised 4-week Pretreatment, 23-week Treatment (11-week Titration; 12-week Maintenance), and 4-week Follow-up Periods. Patients were permitted to receive 1-3 concomitant ASDs. Efficacy assessments in patients with PGTCS included median percentage reduction in seizure frequency per 28 days from Baseline, 50% responder rate, and seizure-freedom rate (Maintenance Phase). Safety assessments included the incidence of treatment-emergent adverse events (TEAEs). Results: A total of 163 patients aged >=12 years with PGTCS were enrolled in Study 332 and included in the Safety Analysis Set, and 162 patients (mean age [standard deviation (SD)]: 28.4 [11.4] years) were included in the Full Analysis Set. Thirty-one patients aged 4 to <12 years with PGTCS (mean age [SD]: 8.5 [2.0] years) were included in the Safety and Full Analysis Sets of Study 311. In patients aged >=12 years, the median reduction in 28-day seizure frequency from Baseline was greater with perampanel 8 mg/day (76.5%) than placebo (38.4%; P<0.0001), and a 69.2% reduction in 28-day seizure frequency (single arm) was observed in patients aged 4 to <12 years with PGTCS (Figure 1). The 50% responder rate was greater with perampanel 8 mg/day (64.2%) compared with placebo (39.5%;
Antiepileptic Drugs