Abstract Details

Title Efficacy and Safety of Adjunctive Perampanel for Myoclonic and Absence Seizures: Post Hoc Pooled Analysis of Adult, Adolescent, and Pediatric Patients in Studies 332, 311, and 232

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 019

Objective Assess the efficacy and safety of adjunctive perampanel for myoclonic and absence seizures in adult/adolescent/pediatric patients using data from Phase II or III clinical studies.

Background In the US, perampanel is approved for partial-onset seizures (POS; adjunctive/monotherapy) in patients aged ≥4 years and primary generalized tonic-clonic seizures (PGTCS; adjunctive) in patients aged ≥12 years. Some anti-seizure medications can exacerbate myoclonic and absence seizures in patients with generalized seizures.

Design/Methods In Study 332 (NCT01393743), patients aged ≥12 years with PGTCS received placebo or adjunctive perampanel 8 mg/day. In Study 311 (NCT02849626), patients aged 4–<12 years with POS or PGTCS received open-label perampanel ≤16 mg/day. In Study 232 (NCT01527006), patients aged 2–<12 years with epilepsy received open-label perampanel ≤0.18 mg/kg/day. Data from patients with myoclonic and/or absence seizures during baseline were pooled. Assessments included median percent change in seizure frequency/28 days, 50% responder rates, and treatment-emergent adverse events (TEAEs).

Results Of 393 patients, 66 had myoclonic seizures (placebo, n=23 [mean (standard deviation) age: 28.1 (8.9) years]; perampanel, n=43 [18.8 (11.9) years]) and 72 had absence seizures (placebo, n=33 [28.8 (13.2) years]; perampanel, n=39 [21.0 (12.2) years]) at baseline; patients with both seizure types are counted in both groups. Reductions in seizure frequency/28 days were observed in both the placebo and perampanel groups: myoclonic, 52.5% and 24.6%; absence, 7.6% and 25.1%, respectively. For placebo and perampanel, 50% responder rates were: myoclonic, 60.9% (n=14/23) and 44.2% (n=19/43); absence, 39.4% (n=13/33) and 38.5% (n=15/39), respectively. TEAEs with placebo and perampanel occurred in 18 (78.3%) and 36 (83.7%) patients with myoclonic seizures, and 25 (75.8%) and 34 (87.2%) patients with absence seizures, respectively. With perampanel, the most common TEAEs were dizziness and fatigue.

Conclusions

Despite small patient numbers, these data suggest adjunctive perampanel does not worsen myoclonic or absence seizures in adult/adolescent/pediatric patients.

Funding: Eisai Inc.

Authors/Disclosures
Christian Brandt, MD (Bethel Epilepsy Center, Mara Hospital) PRESENTER	Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW. Dr. Brandt has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Desitin. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Arvelle. Dr. Brandt has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB. Dr. Brandt has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eisai. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Zogenix. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for GW. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Arvelle. The institution of Dr. Brandt has received research support from Rubin-Stiftung. Dr. Brandt has received publishing royalties from a publication relating to health care.
J B. Renfroe, MD (Child Neurology Center of Northwest Florida)	Dr. Renfroe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Engage Therapeutics. Dr. Renfroe has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eisai. Dr. Renfroe has received intellectual property interests from a discovery or technology relating to health care.
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..
	No disclosure on file
Manoj Malhotra, MD	Dr. Malhotra has received personal compensation for serving as an employee of Eisai.

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Abstract Details