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Differences in patient numbers at trial and non-trial sites should be considered when interpreting these data. Differences in retention rates, titration schedules, and TEAE incidence may reflect prior experience gained by sites involved in previous perampanel clinical trials. Treatment-emergent adverse events (TEAEs) occurred in 52.2% (trial, n=223/427) and 37.7% (non-trial, n=481/1276) of patients most common was dizziness (11.5% vs 6.0%).Įfficacy was observed at both trial and non-trial sites. Based on known titration schedules, the most common schedule at trial sites was every 2 weeks (39.1%) and at non-trial sites was weekly (23.4%). Mean (standard deviation) maximum doses were 7.0 (3.1) (trial) and 6.5 (3.2) (non-trial) mg/day. Most common primary reason for discontinuation was adverse events (26.7%, trial 21.6%, non-trial). SAS included 1703 patients (trial: n=427 non-trial: n=1276). Outcomes were stratified by site type (trial vs non-trial). Dosing experience, efficacy, and safety were assessed.
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Primary endpoint: retention rate (proportion of patients remaining on perampanel for up to 24 months following treatment initiation Safety Analysis Set ). Data were obtained from medical records of patients initiating perampanel after 01-01-2014. Thank you for your patience.Įpilepsy centers involved in previous clinical trials may gain experience using perampanel in their patients.Īssess outcomes in centers involved in perampanel Phase III clinical trials vs those not involved based on data from the Phase IV, retrospective PROVE Study 506 (NCT03208660). We’re experiencing unusually high levels of traffic.
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