Mutua Madrileña Foundation, Fondation de l'Université de Lausanne et Centre Hospitalier Universitaire Vaudois, Instituto Carlos III, CIBERER, National Institutes of Health, Generalitat de Catalunya, Fundació CELLEX.

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Collateral damage may occur in epilepsy management during the coronavirus (COVID-19) pandemic. We aimed to establish the impact of this pandemic on epilepsy patients in terms of patient-reported seizure control and emerging symptoms. Materials & Methods: This is a cross-sectional study including consecutive patients assessed by telephone contact in an epilepsy clinic during the first month of confinement. Demographic and clinical characteristics were recorded, and a 19-item questionnaire was systematically completed. Data regarding the impact of confinement, economic effects of the pandemic, and subjective perception of telemedicine were recorded. Additional clinical data were obtained in patients with a COVID-19 diagnosis. Results: Two hundred and fifty-five patients were recruited: mean age 48.2 ± 19.8 years, 121 (47.5%) women. An increase in seizure frequency was reported by 25 (9.8%) patients. Sixty-eight (26.7%) patients reported confinement-related anxiety, 22 (8.6%) depression, 31 (12.2%) both, and 72 (28.2%) insomnia. Seventythree (28.6%) patients reported a reduction in economic income. Logistic regression analysis showed that tumor-related epilepsy etiology [OR = 7.36 (95% CI 2.17-24.96)], drug-resistant epilepsy [OR = 3.44 (95% CI 1.19-9.95)], insomnia [OR = 3.25 (95% CI 1.18-8.96)], fear of epilepsy [OR = 3.26 (95% CI 1.09-9.74)], and income reduction [OR = 3.65 (95% CI 1.21-10.95)] were associated with a higher risk of increased seizure frequency. Telemedicine was considered satisfactory by 214 (83.9%) patients. Five patients were diagnosed with COVID-19, with no changes in seizure frequency. Conclusions: The COVID-19 pandemic has effects in epilepsy patients. Patients with tumor-related, drug-resistant epilepsy, insomnia, and economic difficulties are at a higher risk of increased seizure frequency. Telemedicine represents a suitable tool in this setting.

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Across a large, treatment-resistant population, add-on perampanel was retained for ≥1 year by 48% of individuals, and 9% were seizure-free for ≥6 months. TEAEs were in line with previous reports in routine clinical use, and less frequent than in the clinical trial setting. No new or unexpected TEAEs were seen. Despite the limitations of observational studies, our data indicate that some individuals may derive a marked benefit from the use of perampanel.

SUMMARYObjectives: To report pooled safety/tolerability and seizure outcome data from adults with uncontrolled partial-onset (focal) seizures (POS) receiving adjunctive brivaracetam (BRV) during phase IIb/III and long-term follow-up (LTFU) studies. Methods: Seizure outcome data were pooled from phase IIb (NCT00175929 and NCT00175825), III/IIIb (NCT00490035, NCT00464269, NCT00504881, and NCT01261325) and associated LTFU studies (NCT00175916, NCT00150800, and NCT01339559). Safety/tolerability data were pooled from these studies plus NCT01405508, NCT01653262, and NCT01728077 (LTFU). Patients received placebo (during core studies) or BRV 5-200 mg/day. Safety/tolerability and seizure outcomes (BRV modal doses 50-200 mg/day) were assessed until January 17, 2014. Results: Of 2,186 patients (97.3% with POS and 2.7% with other seizure types) who received BRV 50-200 mg/day, 2,051 (93.8%) completed core studies and continued in LTFU studies. Total BRV exposure: 5,339.4 patient-years (≥8.0 years in 41 patients); 6-, 12-, 24-, and 60-month retention: 91.0%, 79.8%, 68.1%, and 54.4%, respectively. Safety/tolerability data pooled from 2,186 patients: ≥1 treatmentemergent adverse event (TEAE) reported by 1,848 (84.5%) patients; 1,184 (54.2%) reported ≥1 TEAE considered treatment-related. Most frequent TEAEs (≥10%): headache (20.9%), dizziness (17.5%), somnolence (15.2%), nasopharyngitis (13.2%), fatigue (11.3%), and convulsion (10.6%). Serious TEAEs (SAEs) and treatmentrelated SAEs: 401 (18.3%) and 95 (4.3%) patients, respectively. Of 28 (1.3%) deaths, four (14.3%) were considered possibly treatment related by the investigator. Pooled seizure outcome data (1,836 patients): median POS frequency/28 days at baseline was 8.9; on treatment, median percentage reduction from baseline in POS/28 days was 48.8%, and ≥50% responder rate was 48.7%. Complete seizure freedom: 4.9%, 4.2%, 3.0%, and 3.3% for ≥6, 12, 24, and 60 months, respectively. Improvements were seen in health-related quality of life (HRQoL) from baseline, assessed by Quality of Life in Epilepsy Inventory-31. Significance: Adjunctive BRV treatment in adults with POS was effective and generally well tolerated when administered long-term (≥8.0 years). Retention was high and HRQoL improvements were observed.

The baseline mRS was associated with high mortality risk. It is proposed to use mSTESS to improve the prediction of mortality risk in SE.