Abstract Details

Title A Post-Marketing Observational Study to Evaluate the Safety and Tolerability of Perampanel as Add-On Therapy in Patients with Epilepsy Aged =12 Years

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 6-024

Objective To gather safety information from clinical practice in patients ≥12 years with refractory epilepsy and receiving perampanel as add-on therapy.

Background Perampanel is a once-daily oral antiepileptic drug for focal seizures and primary generalized tonic-clonic seizures. Study 402 (NCT02033902) collected information about clinically important treatment-emergent adverse events (TEAEs) when perampanel was prescribed as add-on therapy in clinical practice.

Design/Methods This multicenter, observational, 52-week cohort study was conducted in patients ≥12 years with refractory epilepsy from Austria, Belgium, Czech Republic, Denmark, France, Israel, Sweden, and UK. Safety data were gathered prospectively from patients at clinic visits. Primary variable was incidence of clinically important TEAEs: dizziness, blurred vision, somnolence, aggression, balance disorders (including ataxia, falls), weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintended pregnancy while taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug–drug interaction.

Results Of 483 patients in the Safety Analysis Set, mean (standard deviation [SD]) age was 38.3 (15.1) years, 48.4% were female, mean (SD) time since diagnosis was 23 (14.8) years, 56.5% had focal impaired awareness seizures, and 48.7% secondarily generalized tonic-clonic seizures. Of 301 (62.3%) patients reporting ≥1 TEAE, 256 (85.0%) had TEAEs judged as mild-to-moderate; 51 (10.6%) patients had TEAEs judged as serious. Clinically important TEAEs were reported by 153 (31.7%) patients with the most common being dizziness (13.9%), balance disorders (5.6%), aggression (5.4%), and weight gain (5.4%). Two reported deaths were judged not related to perampanel. Overall, 219/483 (45.3%) patients treated with perampanel discontinued due to adverse events (130 [26.9%]), inadequate therapeutic effect (39 [8.1%]), or patient choice (31 [6.4%]).

Conclusions

No unusual/unexpected TEAEs were observed. Frequencies of clinically important TEAEs were generally lower than observed in clinical studies, except for incidence of suicidality (2.1% vs 1.0%) and aggression (5.4% vs 5.1%). Majority of TEAEs were judged as mild-to-moderate.

Funding: Eisai Ltd.

Authors/Disclosures
PRESENTER	No disclosure on file
Elinor Ben-Menachem, MD, FAAN (Dept of Clinical Neuroscience)	Dr. Ben-Menachem has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Ben-Menachem has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Arvelle. Dr. Ben-Menachem has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW Pharma. Dr. Ben-Menachem has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Acta Neurologica Scandinvica. The institution of Dr. Ben-Menachem has received research support from zogenic.
Louis Maillard	No disclosure on file
	No disclosure on file
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..

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