Abstract Details

Title Efficacy and Safety of Adjunctive Perampanel 4 mg/day in Pediatric Patients (Aged 4 to <12 Years) with Partial-Onset Seizures (POS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) in Study 311

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P13 - Poster Session 13 (5:30 PM-6:30 PM)

Poster/Presentation
Number 12-006

Objective To report efficacy/safety of adjunctive perampanel 4 mg/day in pediatric patients (aged 4 to <12 years) with POS (with/without secondarily generalized seizures [SGS]) or PGTCS in Study 311.

Background Perampanel is a once-daily oral anti-seizure medication (ASM) for POS and PGTCS. Study 311 (NCT02849626) was a multicenter, open-label, single-arm study of perampanel oral suspension in pediatric patients (aged 4 to <12 years) with POS (with/without SGS) or PGTCS.

Design/Methods The Core Study comprised 4-week Pretreatment, 23-week Treatment (11-week Titration; 12-week Maintenance), and 4-week Follow-up Periods. Efficacy assessments included median percent reductions in seizure frequency per 28 days from baseline during the Treatment Period, and 50% responder and seizure-freedom rates during Maintenance in patients receiving a modal (most frequent) perampanel dose of 4 mg/day. Treatment-emergent adverse events (TEAEs) were assessed in patients receiving perampanel 4 mg/day at onset of their TEAE(s).

Results Overall, 30 patients received perampanel 4 mg/day (modal dose; POS: n=24, SGS: n=10, PGTCS: n=6). Median percent reductions in seizure frequency per 28 days for POS, SGS, and PGTCS were 34.2%, 36.6%, and 100.0%, respectively. Fifty-percent responder rates for POS, SGS, and PGTCS were 10/24 (41.7%), 5/10 (50.0%), and 3/4 (75.0%), respectively. Seizure-freedom rates for POS, SGS, and PGTCS were 3/24 (12.5%), 2/10 (20.0%), and 3/4 (75.0%), respectively. TEAEs occurred in 60/145 (41.4%), 26/52 (50%), and 14/31 (45.2%) patients with POS, SGS, and PGTCS, respectively, who were receiving perampanel 4 mg/day at onset of their TEAE(s). The most common TEAE in patients with POS and SGS was nasopharyngitis (6.2% and 11.5%); dizziness, irritability, and pyrexia were the most common in patients with PGTCS (9.7% each).

Conclusions

These data suggest adjunctive perampanel 4 mg/day is an effective and well tolerated ASM for pediatric patients (aged 4 to ?12 years) with POS (with/without SGS) or PGTCS.

Funding: Eisai Inc.

Authors/Disclosures
Katherine Moretz, MD PRESENTER	No disclosure on file
Manoj Malhotra, MD	Dr. Malhotra has received personal compensation for serving as an employee of Eisai.
	No disclosure on file
	No disclosure on file

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Abstract Details