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Abstract Details

ELEVATE Study 410 Initial Results: Phase IV Study of Perampanel as Monotherapy or First Adjunctive Therapy in Patients Aged =4 Years with Partial-Onset Seizures (POS) or Primary Generalized Tonic-Clonic Seizures (PGTCS)
Epilepsy/Clinical Neurophysiology (EEG)
Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)
018
Report initial results from ELEVATE Study 410 (NCT03288129), an ongoing 12-month, multicenter, open-label, Phase IV study of perampanel monotherapy or first adjunctive therapy in patients aged ≥4 years with POS, with/without secondarily generalized seizures, or PGTCS.
Data from prospective clinical studies on perampanel as monotherapy or early adjunctive therapy are limited as Phase III registration studies evaluated perampanel as adjunctive therapy in treatment-resistant patients.
During Titration, perampanel 2 mg/day will be up-titrated to 4 mg/day based on clinical response and tolerability. Patients could receive ≤12 mg/day depending on their need for additional efficacy (titration: 2-mg/day increments at ≥2-week intervals). Patients receiving enzyme-inducing anti-seizure medications could be up-titrated in 2-mg/day increments at 1-week intervals. Primary endpoint: retention rate at 3, 6, 9, and 12 months. Secondary endpoints: safety and seizure freedom. Baseline seizure counts will be collected retrospectively and prospectively prior to first dose. Seizure diaries will be used to collect seizure counts.

As of 10-01-2020, data are available for 13 patients from 24 US sites (POS, n=10; SGS, n=1; PGTCS, n=3); no patients discontinued. Mean (standard deviation [SD]) age was 45.2 (14.2) years. Compliance rates >90%, 80%–<90%, and 70%–<80% were observed in 69.2% (n=9/13), 7.7% (n=1/13), and 23.1% (n=3/13) of patients, respectively. Mean (SD) compliance rates were 93.2 (12.5) in the total population. Four patients received perampanel as monotherapy and nine as first adjunctive therapy; no patients converted to monotherapy. The last perampanel dose (mg/day) received was 4 (n=3), 6 (n=2), 8 (n=6), 10 (n=1), and 12 (n=1). Treatment-emergent adverse events (TEAEs) occurred in 11/13 (84.6%) patients; no TEAEs led to withdrawal.

Initial results from ELEVATE show that patients were compliant with treatment and perampanel was well tolerated. Additional analyses, including efficacy, are being conducted and will be presented at a later date.

Funding: Eisai Inc.

Authors/Disclosures
Vineet Punia, MD (Cleveland Clinic)
PRESENTER 		Dr. Punia has nothing to disclose.
Pavel Klein, MD, FÂ鶹´«Ã½Ó³»­ (Mid-atlantic Epilepsy and Sleep Center) 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.
Dinesh Kumar Dinesh Kumar has received personal compensation for serving as an employee of Eisai Inc.
Alejandro Salah, MD, PhD, MBA, MHA Dr. Salah has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma.
Manoj Malhotra, MD Dr. Malhotra has received personal compensation for serving as an employee of Eisai.