Epilepsy & behavior : E&B · 2026
Seizure-free days as a clinical outcome measure of reduced epilepsy burden: 5-year outcomes with cenobamate treatment.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Serratosa José M, Gil-Nagel Antonio, Toledo Manuel, Brandt Christian, Thangavelu Karthinathan, Alvarez-Baron Elena, Villanueva Vicente
Аннотация
BACKGROUND: Sustained seizure freedom without intolerable adverse events is the main goal of epilepsy treatment, but may be challenging to achieve for some patients, particularly following the failure of multiple anti-seizure medications (ASMs). A majority of days without seizures is another important clinical outcome that can lead to meaningful improvement in quality of life. The objective of this post-hoc analysis was to evaluate the percentage of seizure-free days by responder groups during the open-label extension (OLE) of study C017 with a focus on patients who achieved near-seizure freedom that was sustained during the duration of the study (≥ 90%-< 100% responders group). The study also evaluated retention rates and the impact of concomitant antiseizure medications.
METHODS: Study C017 (NCT01866111) was a double-blind, randomized, placebo-controlled, dose-response trial evaluating adults 18-70 years old who were taking 1-3 concomitant ASMs. Participants completed the 18-week double-blind treatment period and entered the OLE. This post-hoc analysis quantified the proportion of seizure-free days by responder category and by number and type of concomitant ASMs. The occurrence and severity of treatment-emergent adverse events during the OLE were also reported.
RESULTS: Sixty (16.9%) of the 354 study participants were ≥ 90%-< 100% responders (median age 42.5 years, 46.7% [n = 28] female, median number of concomitant ASMs at baseline was 2). The study population also included 91 (25.7%) patients who were ≥ 50%-< 75% responders, 62 (17.5%) patients who were ≥ 75%-< 90% responders, and 13 (3.7%) patients who were 100% responders. The median duration of cenobamate exposure was 5.6 years for the ≥ 90%-< 100% responders; 1.8 years for the non-responders; 5.5 years for the ≥ 50%-< 75% responders; 5.5 years for the ≥ 75%-< 90% responders; and 5.6 years for the 100% responders. The percentage of seizure-free days during the entire OLE was 97.9% in the ≥ 90%-< 100% responder group, compared to 93.5% in the ≥ 75%-< 90% group and 83.9% in the ≥ 50%-< 75% group. The number and mechanism of action of concomitant ASMs did not meaningfully impact the proportion of days without seizures. The percentage of days with seizures in the ≥ 90%-< 100% responder group declined from 33.2% at baseline to 1.2% at Year 5. At Year 5, the ≥ 90%-< 100% responder group had a high retention rate (90%). The most commonly occurring adverse events were dizziness, somnolence, and headache.
CONCLUSIONS: Participants taking cenobamate who achieved ≥ 90%-< 100% responder rates were seizure-free for nearly 98% of days during the 5 years of the OLE. These results suggest that a high reduction of seizure burden can be achieved and maintained by many people with epilepsy taking cenobamate.
METHODS: Study C017 (NCT01866111) was a double-blind, randomized, placebo-controlled, dose-response trial evaluating adults 18-70 years old who were taking 1-3 concomitant ASMs. Participants completed the 18-week double-blind treatment period and entered the OLE. This post-hoc analysis quantified the proportion of seizure-free days by responder category and by number and type of concomitant ASMs. The occurrence and severity of treatment-emergent adverse events during the OLE were also reported.
RESULTS: Sixty (16.9%) of the 354 study participants were ≥ 90%-< 100% responders (median age 42.5 years, 46.7% [n = 28] female, median number of concomitant ASMs at baseline was 2). The study population also included 91 (25.7%) patients who were ≥ 50%-< 75% responders, 62 (17.5%) patients who were ≥ 75%-< 90% responders, and 13 (3.7%) patients who were 100% responders. The median duration of cenobamate exposure was 5.6 years for the ≥ 90%-< 100% responders; 1.8 years for the non-responders; 5.5 years for the ≥ 50%-< 75% responders; 5.5 years for the ≥ 75%-< 90% responders; and 5.6 years for the 100% responders. The percentage of seizure-free days during the entire OLE was 97.9% in the ≥ 90%-< 100% responder group, compared to 93.5% in the ≥ 75%-< 90% group and 83.9% in the ≥ 50%-< 75% group. The number and mechanism of action of concomitant ASMs did not meaningfully impact the proportion of days without seizures. The percentage of days with seizures in the ≥ 90%-< 100% responder group declined from 33.2% at baseline to 1.2% at Year 5. At Year 5, the ≥ 90%-< 100% responder group had a high retention rate (90%). The most commonly occurring adverse events were dizziness, somnolence, and headache.
CONCLUSIONS: Participants taking cenobamate who achieved ≥ 90%-< 100% responder rates were seizure-free for nearly 98% of days during the 5 years of the OLE. These results suggest that a high reduction of seizure burden can be achieved and maintained by many people with epilepsy taking cenobamate.