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Efficacy, safety, and tolerability of adjunctive eslicarbazepineacetate in patients with focal to bilateral tonic-clonic seizures. To report the efficacy, safety, and tolerability of adjunctive eslicarbazepineacetate (ESL) treatment in reducing focal to bilateral tonic-clonic seizures (FBTCS). Data were pooled from 3 randomized clinical trials (RCTs) of adjunctive ESL in patients with focal
Long-term effects of adjunctive eslicarbazepineacetate in adult Asian patients with refractory focal seizures: Post hoc analysis of a phase III trial. A post hoc analysis of data from Asian patients included in the study BIA-2093-304 was conducted to evaluate the long-term safety/tolerability and efficacy of adjunctive eslicarbazepineacetate (ESL) in adult Asian patients with refractory focal
Eslicarbazepineacetate (Zebinix) - as adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures Published 11 February 2019 Product Update: eslicarbazepineacetate 200mg and 800mg tablets and oral suspension 50mg/mL (Zebinix®) SMC2087 Eisai Ltd 10 August 2018 (Issued 11 January 2019) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows: ADVICE: following an abbreviated submission eslicarbazepineacetate (Zebinix®) is accepted for restricted use within NHSScotland. Indication under review: as adjunctive therapy in adolescents and children aged above 6 years
Antiepileptogenesis after stroke-trials and tribulations: Methodological challenges and recruitment results of a Phase II study with eslicarbazepineacetate. There is currently no evidence to support the use of antiseizure medications to prevent unprovoked seizures following stroke. Experimental animal models suggested a potential antiepileptogenic effect for eslicarbazepineacetate (ESL
Time to baseline seizure count in patients with focal seizures receiving adjunctive eslicarbazepineacetate in a phase IV clinical trial. The efficacy and tolerability of eslicarbazepineacetate (ESL), a once-daily, orally-administered, anti-seizure medication (ASM), have primarily been established in treatment-resistant epilepsy patients, the population most often enrolled in clinical trials
Potential efficacy and safety of eslicarbazepineacetate oral loading in patients with epilepsy. Eslicarbazepineacetate (ESL) is a new antiseizure medication (ASM) approved as an adjunctive therapy or monotherapy for focal-onset seizures. We performed this study to explore the potential efficacy and safety of ESL oral loading in selected patients with epilepsy. Thirty adult patients with status
Long-term quality of life in patients with focal seizures treated with adjunctive eslicarbazepineacetate. By controlling seizures, anti-seizure medications can improve health-related quality of life (HRQOL). Data from a post-hoc pooled analysis of adjunctive eslicarbazepineacetate (ESL) was used to describe HRQOL measures, including overall quality of life, seizure worry, emotional well-being
Lipid profile with eslicarbazepineacetate and carbamazepine monotherapy in adult patients with newly diagnosed focal seizures: post hoc analysis of a phase III trial and open-label extension study. Antiseizure medications can have negative effects on plasma lipid levels. To evaluate plasma lipid changes in patients with newly diagnosed focal epilepsy treated with eslicarbazepineacetate (ESL
Time to sustained responder status in patients with focal seizures treated with adjunctive eslicarbazepineacetate. Rapid and sustained clinical responses are critical in improving long-term outcomes in epilepsy. While a 50 % reduction from baseline in standardized seizure frequency (SSF) is often cited as a measure of clinically meaningful efficacy, sustained response (SR) is an alternative method that allows the assessment of onset and durability of the response. Time to sustained response in SSF of ≥ 50 %, ≥ 75 %, ≥ 90 %, and 100 % was assessed for pooled data from 3 similar randomized clinical trials of adjunctive eslicarbazepineacetate (ESL). Patients with focal seizures on stable doses of 1-2 antiseizure medications were randomized to placebo, ESL 800 mg/day, or ESL 1200 mg/day
Eslicarbazepineacetate (Zebinix) - treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy Non Submission eslicarbazepineacetate 200mg and 800mg tablets (Zebinix ®) SMC2090 Eisai Ltd 4 May 2018 ADVICE: in the absence of a submission from the holder of the marketing authorisation eslicarbazepineacetate (Zebinix ®
Psychiatric adverse events in three phase III trials of eslicarbazepineacetate for focal seizures. Eslicarbazepineacetate (ESL) is a once-daily (QD), oral anti-seizure medication for the treatment of focal (partial-onset) seizures. Here, we evaluate risk factors for the development of psychiatric treatment-emergent adverse events (TEAEs) in clinical trials of adjunctive ESL in adults
The pharmacokinetic, safety, and tolerability profiles of eslicarbazepineacetate are comparable between Korean and White subjects. Eslicarbazepineacetate (ESL) is a prodrug antiseizure medication for the treatment of focal seizures. ESL shows a well-established pharmacokinetic (PK)-pharmacodynamic relationship and has similar extrinsic epilepsy-related factors across ethnicities. This study
Long-term therapeutic effect of eslicarbazepineacetate in children: An open-label extension of a cognition study in children aged 6-16 years. In Europe, eslicarbazepineacetate (ESL) is approved as adjunctive therapy for the treatment of focal seizures (FS) in children aged >6 years. In the US, ESL is approved as both monotherapy and adjunctive therapy for the treatment of FS in patients aged
Comparative analysis of the safety and tolerability of eslicarbazepineacetate in older (≥60 years) and younger (18-59 years) adults. To investigate the safety and tolerability of eslicarbazepineacetate (ESL), a once-daily oral anti-seizure drug (ASD), in older and younger adult patient populations. Two post-hoc pooled data analyses were performed: one from three Phase III studies in patients
Safety of EslicarbazepineAcetate in Elderly Versus Non-Elderly Patients with Focal Seizures: From Pooled Data of Clinical Studies to 8 Years of Post-Marketing Experience. The prevalence of epilepsy increases in elderly patients aged > 65 years, and treatment is challenging because clinical data are limited. Our objective was to evaluate the safety of eslicarbazepineacetate (ESL) in patients
Efficacy and safety of eslicarbazepineacetate as a first or later adjunctive therapy in patients with focal seizures. We report outcomes from an open-label, non-randomized, 24-week study of eslicarbazepineacetate (ESL) in adults at earlier and later stages of their treatment history for focal seizures, conducted in a real-world clinical setting. ESL was taken as the first adjunctive therapy
Long-term efficacy and safety of eslicarbazepineacetate monotherapy for adults with newly diagnosed focal epilepsy: An open-label extension study. To assess the efficacy, safety, and tolerability of eslicarbazepineacetate (ESL) monotherapy during long-term treatment. An open-label extension (OLE) study was conducted in adults completing a phase 3, randomized, double-blind, noninferiority trial
Associations between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life in patients with focal seizures treated with adjunctive eslicarbazepineacetate: Post hoc analyses of clinical tria The relationships between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life (HRQoL) may be important for determining the overall impact of medication therapy on patients with epilepsy. The objectives of these post hoc analyses of the global Phase III 093-0304 trial (NCT00988429, Study 304) of adjunctive eslicarbazepineacetate (ESL) in patients with refractory focal (partial-onset) seizures (FS) were to evaluate associations between seizure severity change, measured
Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepineacetate. To evaluate cutaneous allergic reactions in clinical trials of adjunctive eslicarbazepineacetate (ESL) for focal seizures. Data were analyzed from three phase III randomized, double-blind, placebo-controlled studies of adjunctive ESL in adults (placebo, n = 426; ESL, n = 1021) and two randomized, double