Effects of cenobamate on cognitive performance of epilepsy patients

Schütz, Elisa; Wagner, Kathrin; Metternich, Birgitta; Papadopoulou, Georgia; Kravalis, Kristina; Heers, Marcel; Martínez-Lizana, Eva; Castillo-Rodriguez, Maria; Altenmüller, Dirk‐Matthias; Schulze‐Bonhage, Andreas; Hirsch, M.

doi:10.1016/j.seizure.2022.10.004

Cited by 15 publications

(13 citation statements)

References 23 publications

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“…Indeed, a series of 50 patients treated with CNB who were evaluated prospectively using EpiTrack© remained stable or showed improved cognitive performance. 19 Although a low dosage of CNB was used in this study at the moment of evaluation (median 125 mg/day), a reduction in the number and dosage of concomitant ASMs, as performed in our series, could also improve outcomes. In early clinical development, DRESS was reported in three of 953 participants who received CNB using a faster titration.…”

Section: Discussionmentioning

confidence: 73%

“…Although CNS‐related AEs were the most frequently reported AEs in all series, their severity does not appear to reduce cognitive outcomes over time. Indeed, a series of 50 patients treated with CNB who were evaluated prospectively using EpiTrack© remained stable or showed improved cognitive performance 19 . Although a low dosage of CNB was used in this study at the moment of evaluation (median 125 mg/day), a reduction in the number and dosage of concomitant ASMs, as performed in our series, could also improve outcomes.…”

Section: Discussionmentioning

confidence: 87%

“…[16][17][18] However, the number of publications with CNB in this setting are limited and include low numbers of patients. [19][20][21][22][23][24] Expanded Access Programs (EAPs) provide an opportunity to expand the real-world dataset for CNB in a larger series of patients in order to gain knowledge on its clinical use. 25 The aims of this study were to describe the demographics of patients participating in a Spanish EAP, to report the effectiveness and tolerability of CNB in a large population, and to collate information on the use of CNB in clinical practice.…”

Section: Key Pointsmentioning

confidence: 99%

“…To further characterize the safety and efficacy profile of CNB and to evaluate the dosage, combinations, concomitant ASM adjustment, and use in populations excluded from clinical trials, it is necessary to go beyond clinical trial designs and to collect data from real‐world clinical practice 16–18 . However, the number of publications with CNB in this setting are limited and include low numbers of patients 19–24 . Expanded Access Programs (EAPs) provide an opportunity to expand the real‐world dataset for CNB in a larger series of patients in order to gain knowledge on its clinical use 25 …”

Section: Introductionmentioning

confidence: 99%

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Real‐world safety and effectiveness of cenobamate in patients with focal onset seizures: Outcomes from an Expanded Access Program

Villanueva,

Santos‐Carrasco,

Cabezudo‐García

et al. 2023

Epilepsia Open

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ObjectiveThis study investigated early, real‐world outcomes with cenobamate (CNB) in a large series of patients with highly drug‐resistant epilepsy within a Spanish Expanded Access Program (EAP).MethodThis was a multicenter, retrospective, observational study in 14 hospitals. Inclusion criteria were age ≥18 years, focal seizures, and EAP authorization. Data were sourced from patient clinical records. Primary effectiveness endpoints included reductions (100%, ≥90%, ≥75%, and ≥50%) or worsening in seizure frequency at 3‐, 6‐, and 12‐month visits and at the last visit. Safety endpoints included rates of adverse events (AEs) and AEs leading to discontinuation.ResultsThe study included 170 patients. At baseline, median epilepsy duration was 26 years and median number of seizures/month was 11.3. The median number of prior antiseizure medications (ASMs) and concomitant ASMs were 12 and 3, respectively. Mean CNB dosages/day were 176 mg, 200 mg, and 250 mg at 3, 6, and 12 months. Retention rates were 98.2%, 94.5%, and 87% at 3, 6, and 12 months. At last available visit, the rate of seizure freedom was 13.3%; ≥90%, ≥75%, and ≥50% responder rates were 27.9%, 45.5%, and 63%, respectively. There was a significant reduction in the number of seizures per month (mean: 44.6%; median: 66.7%) between baseline and the last visit (P < 0.001). Responses were maintained regardless of the number of prior or concomitant ASMs. The number of concomitant ASMs was reduced in 44.7% of patients. The cumulative percentage of patients with AEs and AEs leading to discontinuation were 68.2% and 3.5% at 3 months, 74.1% and 4.1% at 6 months, and 74.1% and 4.1% at 12 months. The most frequent AEs were somnolence and dizziness.SignificanceIn this highly refractory population, CNB showed a high response regardless of prior and concomitant ASMs. AEs were frequent but mostly mild‐to‐moderate, and few led to discontinuation.

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Section: Discussionmentioning

confidence: 73%

Section: Discussionmentioning

confidence: 87%

Section: Key Pointsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Real‐world safety and effectiveness of cenobamate in patients with focal onset seizures: Outcomes from an Expanded Access Program

Villanueva,

Santos‐Carrasco,

Cabezudo‐García

et al. 2023

Epilepsia Open

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“…Although there are no studies that comprehensively assess cognition in humans after CNB treatment, Schuetz et al, (2022) explored the effects of CNB on cognition using the EpiTrack after 3 months, showing that most patients remained stable (72%), followed by 16% who improved and 12% who showed a deterioration. Similar results have been found in Study 1, since 68.7% of patients remained stable, 18.8% improved and 12.5% showed a deterioration.…”

Section: Discussionmentioning

confidence: 99%

Prospective study of cenobamate on cognition, affectivity, and quality of life in focal epilepsy

Catalán‐Aguilar,

Hampel,

Cano‐López

et al. 2023

Epilepsia Open

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ObjectiveCenobamate is a recently approved antiseizure medication that proved to be safe and effective in randomized controlled trials. However, little is known about its impact on some areas frequently affected in epilepsy. For this reason, we explored the effects of cenobamate in cognitive performance, as well as on negative affectivity and quality of life in a sample of patients with drug‐resistant epilepsy.MethodsTwo prospective cohort studies were carried out. In Study 1, 32 patients (22 men and 10 women) underwent a baseline (T0) and a short‐term (T1) neuropsychological assessment after three months of cenobamate administration. In Study 2, 22 patients (16 men and 6 women) from the T1 sample also underwent a baseline and a follow‐up evaluation (T2) six months after T0.ResultsNo significant differences were found in cognitive variables, negative affectivity, and quality of life either in Study 1 or Study 2. Similarly, based on the reliable change index it was found that most patients showed no changes in these variables.SignificanceThese results suggest that cenobamate is a safe antiseizure medication in terms of cognition, negative affectivity, or quality of life since no adverse events have been found after three and six months of treatment.

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New GABA-Targeting Therapies for the Treatment of Seizures and Epilepsy: I. Role of GABA as a Modulator of Seizure Activity and Recently Approved Medications Acting on the GABA System

Perucca,

Bialer,

White

2023

CNS Drugs

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Effects of cenobamate on cognitive performance of epilepsy patients

Cited by 15 publications

References 23 publications

Real‐world safety and effectiveness of cenobamate in patients with focal onset seizures: Outcomes from an Expanded Access Program

Real‐world safety and effectiveness of cenobamate in patients with focal onset seizures: Outcomes from an Expanded Access Program

Prospective study of cenobamate on cognition, affectivity, and quality of life in focal epilepsy

New GABA-Targeting Therapies for the Treatment of Seizures and Epilepsy: I. Role of GABA as a Modulator of Seizure Activity and Recently Approved Medications Acting on the GABA System

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