Abstract Details

Title ELEVATE Study 410: Phase IV Study of Perampanel as Monotherapy or First Adjunctive Therapy in Patients Aged =4 Years with Focal-Onset Seizures (FOS) or Generalized Tonic-Clonic Seizures (GTCS)

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 151

Objective To present interim efficacy and safety results from ELEVATE (NCT03288129) by seizure type.

Background ELEVATE was an open-label, Phase IV study of perampanel as monotherapy/first adjunctive therapy in patients aged ≥4 years with FOS, with/without focal to bilateral tonic-clonic seizures (FBTCS), or GTCS.

Design/Methods ELEVATE consisted of Screening, Titration (≤13 weeks), Maintenance (39 weeks), and Follow-up (4 weeks) Periods. During Titration, patients received perampanel 2 mg/day, titrated to a maximum of 12 mg/day. Dose increases were ≥2 weeks apart or weekly for patients taking a non-enzyme-inducing anti-seizure medication (EIASM) or an EIASM, respectively. Primary endpoint: retention rate at 3, 6, 9, and 12 months. Secondary endpoints: seizure freedom (Maintenance Period) and safety. Exploratory endpoints (Maintenance Period): median percent reduction in seizure frequency/28 days; 50% responder rate.

Results As of March 23, 2021, the Safety Analysis Set included 23 patients with FOS (n=16 [FBTCS, n=1]) or GTCS (n=7); 12 completed and 11 discontinued. Full Analysis Set: 10 patients [FOS (n=8); GTCS (n=2)]. Mean (SD) daily perampanel dose (mg) (Maintenance) by seizure type: FOS, 6.0 (1.5); FBTCS, (no data), GTCS, 5.8 (3.2). Retention rates at Months 3, 6, 9, and 12: 93.8% and 57.1%; 68.8% and 42.9%; 56.3% and 42.9%; 37.5% and 42.9% for patients with FOS and GTCS, respectively. Retention rate at Month 3 for patients with FBTCS: 100.0%. Seizure freedom was achieved by one patient with FOS (16.7% [observed]); ≥50% reduction in seizure frequency achieved by four evaluable patients with FOS (100.0%; [last observation carried forward (LOCF)]). Median percent reduction/28 days in FOS frequency: 65.3% (n=4; LOCF); treatment-emergent adverse events: 13 (81.3%), 0 (0.0%), and 7 (100.0%) patients with FOS, FBTCS, and GTCS, respectively.

Conclusions Perampanel as monotherapy/first add-on was well tolerated with no unexpected safety concerns. Additional analyses will be included in the presentation.

Authors/Disclosures
Pavel Klein, MD, FAAN (Mid-atlantic Epilepsy and Sleep Center) PRESENTER	The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Aquestive. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurelis. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB Pharma. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Life Sience. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eisai. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alliance. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Arvelle Therapeutics. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Aquestive. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eisai. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for UCB Pharma. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for SK Life Sciences. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Klein has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for PrevEp. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Fenwick . Dr. Klein has received research support from DOD/CURE.
Omar Samad, PhD (Mallinckrodt Pharmaceuticals)	Dr. Samad has received personal compensation for serving as an employee of Eisai.
Dinesh Kumar	Dinesh Kumar has received personal compensation for serving as an employee of Eisai Inc.
Stella L. Ngo, PhD	Dr. Ngo has received personal compensation for serving as an employee of Neurelis Inc.. Dr. Ngo has received personal compensation for serving as an employee of Neurelis Inc..
Manoj Malhotra, MD	Dr. Malhotra has received personal compensation for serving as an employee of Eisai.

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