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Abstract Details

Efficacy and Safety of Adjunctive Perampanel in South Korean Patients with Partial-Onset Seizures (POS) or Primary Generalized Tonic-Clonic Seizures (PGTCS): Post Hoc Analysis of Phase II and III Double-Blind and Open-Label Extension (OLEx) Studies
Epilepsy/Clinical Neurophysiology (EEG)
P14 - Poster Session 14 (8:00 AM-9:00 AM)
12-001
To assess efficacy and safety of adjunctive perampanel in a subgroup of South Korean patients with POS, with/without secondarily generalized seizures (SGS), or PGTCS from double-blind studies (Phase II: 235; Phase III: 304, 305, 306, 335, and 332) and their OLEx phases (235 OLEx, 307, 335 OLEx, and 332 OLEx).
Perampanel is a once-daily oral anti-seizure medication for POS and PGTCS.
Efficacy assessments in the Full Analysis Set (FAS) included median reduction in seizure frequency/28 days, and 50% responder and seizure-freedom rates (placebo vs perampanel [POS/SGS, 4–12 mg/day; PGTCS, 8 mg/day]). Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set (SAS) across all seizure types.

The SAS included 241 South Korean patients (placebo, n=65; perampanel, n=176); the FAS included 225 patients (placebo, n=64; perampanel, n=161). Across double-blind studies, median reductions in seizure frequency/28 days (placebo vs perampanel) were 16.1% vs 25.8% (POS), -16.6% vs 55.6% (SGS), and -54.8% vs 72.3% (PGTCS). Corresponding 50% responder rates were 20.0% (n=12/60) vs 32.9% (n=52/158), 20.0% (n=2/10) vs 59.5% (n=25/42), and 0.0% (n=0/4) vs 66.7% (n=2/3) for POS, SGS, and PGTCS, respectively; seizure-freedom rates were 1.7% (n=1/60) vs 1.3% (n=2/158), 10.0% (n=1/10) vs 26.2% (n=11/42), and 0.0% (n=0/3) vs 33.3% (n=1/3), respectively.

Across double-blind studies, TEAEs occurred in 47 (72.3%) placebo-treated and 144 (81.8%) perampanel-treated patients; with perampanel, the most common were dizziness (n=75 [42.6%]) and somnolence (n=42 [23.9%]).

Overall, 215 patients entered the OLEx studies (POS, n=210; SGS, n=60; PGTCS, n=5); median reductions in seizure frequency/28 days during Year 1 were: POS, 18.4%; SGS, 55.8%; PGTCS, 84.0%. TEAEs occurred in 52/215 (24.2%) patients.

In this post hoc analysis of adjunctive perampanel in South Korean patients with POS, SGS, or PGTCS, efficacy and safety outcomes were generally consistent with the results from the overall patient populations.

Funding: Eisai Inc.
Authors/Disclosures
Manoj Malhotra, MD
PRESENTER
Dr. Malhotra has received personal compensation for serving as an employee of Eisai.
No disclosure on file
No disclosure on file
Alejandro Salah, MD, PhD, MBA, MHA Dr. Salah has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma.