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Abstract Details

Efficacy and Safety of Low- and High-Dose Perampanel as First Adjunctive Therapy in Patients With Partial-Onset Seizures (POS) With or Without Secondarily Generalized Seizures (SGS): Post Hoc Analysis of the FAME Study
Epilepsy/Clinical Neurophysiology (EEG)
Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)
007
Assess the efficacy and safety of low- and high-maintenance doses of adjunctive perampanel in a post hoc analysis of the FAME study (NCT02726074).
In the US and Korea, perampanel is approved for POS (adjunctive/monotherapy) in patients aged ≥4 years and primary generalized tonic-clonic seizures (adjunctive) in patients aged ≥12 (≥7, Korea) years.
Patients were aged ≥12 years with POS, with/without SGS, and had failed antiepileptic drug monotherapy. Perampanel was up-titrated to ≤12 mg/day (12 weeks), followed by a 24-week Maintenance Period. Endpoints, stratified by low- (4/6 mg/day) and high-dose (8/10/12 mg/day) perampanel, included 50% responder/seizure-freedom rates, median percent change in seizure frequency/28 days, and treatment-emergent adverse events (TEAEs).

The Full Analysis Set included 85 patients with POS (16 had SGS); 70 (82.4%; including all SGS patients) received low-dose perampanel (4 mg/day, n=43 [61.4%]; 6 mg/day, n=27 [38.6%]) and 15 (17.6%) received high-dose (8 mg/day, n=12 [80.0%]; 10 mg/day, n=2 [13.3%]; 12 mg/day, n=1 [6.7%]). During Maintenance, the 50% responder rates were 88.6% (n=62/70; low-dose) vs 40.0% (n=6/15, P=0.0002; high-dose); seizure-freedom rates were 54.3% (n=38/70) vs 13.3% (n=2/15, P=0.0039); median percent reduction in POS frequency/28 days was 100.0% (n=69/70) vs 16.7% (n=15/15, P=0.0001), respectively. In SGS patients, 50% responder and seizure-freedom rates were 87.5% (n=14/16) and 75.0% (n=12/16), respectively. In the Safety Analysis Set, 56/73 (76.7%) and 9/15 (60.0%) patients receiving low- or high-dose perampanel experienced TEAEs, respectively. Six patients experienced a serious TEAE (n=5 vs n=1, respectively), and four discontinued due to a TEAE (all low-dose).

Seizure improvements were seen across low- (4/6 mg/day) and high-dose (8/10/12 mg/day) groups and perampanel was generally well tolerated. Despite higher patient numbers in the low-dose group, these results suggest some patients may achieve seizure control with low-dose perampanel; however, others may require up-titration to higher doses based on response.

Funding: Eisai Korea Inc.

Authors/Disclosures
Dae W. Seo, MD (Samsung Medical Center 50)
PRESENTER 		Dr. Seo has nothing to disclose.
Hugh Jiwoong Lee Hugh Jiwoong Lee has nothing to disclose.
Amitabh Dash, MD Amitabh Dash, MD has nothing to disclose.
Sang Kun Lee, MD (Seoul national University Hospital) Prof. Lee has nothing to disclose.
Sang-Ahm Lee, MD (Asan Medical Center) Dr. Lee has nothing to disclose.
Manoj Malhotra, MD Dr. Malhotra has received personal compensation for serving as an employee of Eisai.