Abstract Details

Title Effect of Concomitant Enzyme-Inducing Antiepileptic Drugs (EIAEDs) on the Safety and Efficacy of Adjunctive Perampanel in Patients Aged 4 to ?12 years with Partial-Onset Seizures (POS): Final Results from the 311 Core Study

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 6-007

Objective

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

Background

Perampanel is a once-daily oral antiepileptic drug (AED) for POS and PGTCS. In this subgroup analysis, we report final safety and efficacy data from the Core Study stratified by concomitant baseline EIAED use.

Design/Methods

The Core Study consisted of 4-week Pre-treatment, 23-week Treatment, and 4-week Follow-up Periods. Patients must have been on stable doses of 1-3 concomitant AEDs; 1 EIAED (carbamazepine, oxcarbazepine, eslicarbazepine, or phenytoin) was permitted. Perampanel was titrated to ≤16 mg/day for EIAED and ≤12 mg/day for non-EIAED patients (≤12 mg/day in Japanese patients irrespective of EIAED status).

Results A total of 180 patients (EIAED, n=48; non-EIAED, n=132) received ≥1 perampanel dose. The most common EIAEDs were carbamazepine (14%) and oxcarbazepine (11%). In the Safety Analysis Set (N=180), treatment-emergent adverse events were reported in 40 (83.3%) and 120 (90.9%) patients with and without EIAEDs, respectively; the most common were somnolence and nasopharyngitis in both subgroups. For POS, median percent reduction from Baseline 28-day seizure frequency was 34.0% vs 42.2% with and without EIAEDs, respectively; for SGS, this was 59.5% vs 57.8%, respectively. 50% responder rates were similar between patients with and without EIAEDs for POS (45.7% vs 47.1%, respectively), and SGS (54.5% vs 67.4%, respectively). Seizure freedom with and without EIAEDs was achieved by 5 (10.9%) and 12 (11.8%) POS patients, respectively, and 1 (9.1%) and 9 (20.9%) SGS patients, respectively.

Conclusions

In this subgroup analysis from Study 311, adjunctive perampanel was generally well tolerated and efficacious in patients aged 4 to ?12 years with POS, with/without SGS, regardless of baseline concomitant EIAED status.

Funding: Eisai Inc.

Authors/Disclosures
PRESENTER	No disclosure on file
	No disclosure on file
Andras Fogarasi	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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