Abstract Details

Title Safety and Efficacy of Adjunctive Perampanel in Younger (aged 4 to <7 years) and Older (7 to <12 years) Pediatric Patients with Partial-Onset Seizures (POS) or Primary Generalized Tonic-Clonic Seizures (PGTCS): Final Results from the 311 Core Study

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 6-021

Objective

Study 311 (NCT02849626) assessed the safety, tolerability, pharmacokinetics, and efficacy of adjunctive perampanel in pediatric patients aged 4 to <12 years with POS (with/without secondarily generalized seizures [SGS]) or PGTCS.

Background Perampanel is a once-daily oral antiepileptic drug for POS and PGTCS. In this subgroup analysis, we report final Core Study safety and efficacy data stratified by age: 4 to <7 years and 7 to <12 years.

Design/Methods The Core Study consisted of 4-week Pre-treatment, 23-week Treatment, and 4-week Follow-up Periods. Endpoints included perampanel safety and tolerability (primary), median percent change in seizure frequency per 28 days from Baseline and 50% responder and seizure-freedom rates (secondary).

Results

A total of 180 patients received ≥1 perampanel dose. In the Safety Analysis Set (4 to <7 years, n=46; 7 to <12 years, n=134), 45 (97.8%) and 115 (85.8%) patients reported treatment-emergent adverse events, respectively; the most common were somnolence, nasopharyngitis, dizziness, and irritability. Median percent reductions in seizure frequency per 28 days for POS, PGTCS, and SGS were: 42.7%, 56.5%, and 56.3%, respectively (4 to <7 years); and 40.1%, 81.9%, and 60.6%, respectively (7 to <12 years). 50% responder rates were similar between age cohorts for POS (18/40 [45.0%] vs 51/108 [47.2%]) and PGTCS (2/3 [66.7%] vs 12/19 [63.2%]) or SGS (12/17 [70.6%] vs 23/37 [62.2%]) in the younger vs older age cohorts, respectively. Seizure freedom was achieved in 3/40 (7.5%) vs 14/108 (13.0%) patients with POS, 2/3 (66.7%) vs 10/19 (52.6%) patients with PGTCS, and 3/17 (17.6%) vs 7/37 (18.9%) patients with SGS in the younger vs older age cohorts, respectively.

Conclusions

These data suggest that adjunctive perampanel is generally well tolerated and efficacious in pediatric patients aged 4 to <7 and 7 to <12 years with POS, PGTCS, or SGS.

Funding: Eisai Inc.

Authors/Disclosures
Andras Fogarasi PRESENTER	No disclosure on file
Robert Flamini, MD	Dr. Flamini has received personal compensation in the range of $0-$499 for serving as a Consultant for Biocodex. Dr. Flamini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. Dr. Flamini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Jazz Pharmaceuticals.
	No disclosure on file
Steven M. Phillips, DO (University of Nebraska Medical Center)	Dr. Phillips has nothing to disclose.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

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