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Eslicarbazepine

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1. Eslicarbazepine acetate (Zebinix) - epilepsy

Eslicarbazepine acetate (Zebinix) - epilepsy Final Appraisal Recommendation Advice No: 1019 – June 2019 Eslicarbazepine acetate (Zebinix ® ) 200 mg and 800 mg tablets, and 50 mg/ml oral suspension Limited submission by Eisai Ltd Additional note(s): • This advice incorporates and replaces the existing AWMSG recommendation for eslicarbazepine acetate (Zebinix ® ) as an option for restricted use within NHS Wales. Eslicarbazepine acetate should be restricted to treatment of highly refractory (...) Report (ASAR), the Preliminary Appraisal Recommendation (PAR) and the applicant company’s response to the PAR, clinical expert opinion (where available), the views of patients/patient carers (where available) and the lay member perspective. This recommendation has been ratified by Welsh Government and will be considered for review every three years. Recommendation of AWMSG Eslicarbazepine acetate (Zebinix ® ) is recommended as an option for restricted use within NHS Wales. Eslicarbazepine acetate

2019 All Wales Medicines Strategy Group

2. Eslicarbazepine acetate (Zebinix) - as adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures

Eslicarbazepine acetate (Zebinix) - as adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures Published 11 February 2019 Product Update: eslicarbazepine acetate 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 eslicarbazepine acetate (Zebinix ® ) is accepted for restricted use within NHSScotland. Indication under review: as adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation. SMC restriction: patients with highly refractory epilepsy who have been heavily pre-treated and remain uncontrolled with existing anti-epileptic drugs. SMC

2019 Scottish Medicines Consortium

3. Eslicarbazepine acetate add-on for drug-resistant partial epilepsy. Full Text available with Trip Pro

Eslicarbazepine acetate add-on for drug-resistant partial epilepsy. This is an updated version of the Cochrane Review published in the Cochrane Library 2011, Issue 12.The majority of people with epilepsy have a good prognosis, but up to 30% of people continue to have seizures despite several regimens of antiepileptic drugs. In this review, we summarized the current evidence regarding eslicarbazepine acetate (ESL) when used as an add-on treatment for drug-resistant partial epilepsy.To evaluate

2017 Cochrane

4. Eslicarbazepine acetate (Zebinix) - treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy

Eslicarbazepine acetate (Zebinix) - treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy Non Submission eslicarbazepine acetate 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 eslicarbazepine acetate (Zebinix ® ) is not recommended for use within NHS Scotland. Indication under review: As monotherapy in the treatment of partial

2018 Scottish Medicines Consortium

5. Long-term safety and efficacy following conversion to eslicarbazepine acetate monotherapy in adults with focal seizures. (Abstract)

Long-term safety and efficacy following conversion to eslicarbazepine acetate monotherapy in adults with focal seizures. To assess the long-term safety and efficacy of eslicarbazepine acetate (ESL) monotherapy in adults with focal seizures (FS).Study 050 was a long-term, multicenter, open-label (OL) safety extension of two conversion-to-ESL monotherapy studies in adults with refractory FS. After participating in Study 045 or 046, patients started on ESL 1600 mg once daily (QD) (or 1200 mg

2019 Epilepsy research Controlled trial quality: uncertain

6. Serum sodium levels and related treatment-emergent adverse events during eslicarbazepine acetate use in adults with epilepsy. Full Text available with Trip Pro

Serum sodium levels and related treatment-emergent adverse events during eslicarbazepine acetate use in adults with epilepsy. To examine the frequency of hyponatremia and potentially related symptoms in clinical trials of eslicarbazepine acetate (ESL) in adults with focal- (partial-) onset seizures.This post hoc, exploratory analysis included data from three controlled phase 3 trials of adjunctive ESL (400-1200 mg once daily), two phase 3 trials of ESL monotherapy (1200-1600 mg once daily

2019 Epilepsia

7. Comparative neuropsychological effects of carbamazepine and eslicarbazepine acetate. (Abstract)

Comparative neuropsychological effects of carbamazepine and eslicarbazepine acetate. People with epilepsy are at increased risk for neuropsychological dysfunction due to multiple factors, of which the most amendable are antiseizure medications (ASMs). Antiseizure medication effectiveness is frequently determined by tolerability. In this study, we compared the neuropsychological effects of eslicarbazepine acetate (ESL) and carbamazepine immediate-release (CBZ) using a randomized, double-blind (...) = 8.9 μg/ml and ESL = 15.3 μg/ml. Omnibus z-score was significantly better for ESL (p = .0001). For individual measures, executive function and selective attention tests were statistically significantly better for ESL. Individual test raw means favored ESL over CBZ on 22 of 30 measures (p = .016, 2-tailed sign test). Eslicarbazepine acetate demonstrated less adverse neuropsychological effects than CBZ.Copyright © 2019 Elsevier Inc. All rights reserved.

2019 Epilepsy & behavior : E&B Controlled trial quality: uncertain

8. Effects of adjunctive eslicarbazepine acetate on serum lipids in patients with partial-onset seizures: Impact of concomitant statins and enzyme-inducing antiepileptic drugs. Full Text available with Trip Pro

Effects of adjunctive eslicarbazepine acetate on serum lipids in patients with partial-onset seizures: Impact of concomitant statins and enzyme-inducing antiepileptic drugs. To evaluate the effects of eslicarbazepine acetate (ESL) on lipid metabolism and to determine whether reduced statin exposure during ESL therapy has clinical consequences.We conducted a post-hoc analysis of pooled data for serum lipids (laboratory values) from three phase III, multicenter, randomized, double-blind, placebo

2019 Epilepsy research

9. Health-related quality of life in patients treated with eslicarbazepine acetate monotherapy: Pooled analysis from two registered clinical trials. (Abstract)

Health-related quality of life in patients treated with eslicarbazepine acetate monotherapy: Pooled analysis from two registered clinical trials. While antiepileptic drug (AED) treatment effectiveness is traditionally assessed based on seizure frequency reduction (SFR), the overall value of AEDs in managing epilepsy and associated sequelae may be best assessed by how patients feel and function in terms of overall health-related quality of life (HRQoL). We conducted a pooled analysis (...) of the Quality of Life in Epilepsy-31 (QOLIE-31) questionnaire from two phase 3 trials to explore the effect of response to conversion to eslicarbazepine acetate (ESL) monotherapy on HRQoL.Data were pooled from two multicenter, randomized, double-blind, historical control phase 3 trials examining conversion to ESL monotherapy in adults with inadequately controlled partial-onset seizures (POS). The relationship between HRQoL and ESL treatment response was examined through the analysis of week 18 QOLIE-31

2019 Epilepsy & behavior : E&B Controlled trial quality: predicted high

10. Aptiom (eslicarbazepine acetate) - As an add-on medication to treat seizures associated with epilepsy

Aptiom (eslicarbazepine acetate) - As an add-on medication to treat seizures associated with epilepsy Drug Approval Package: Brand Name (Generic Name) NDA # Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Aptiom (Eslicarbazepine Acetate) Tablets Company: Sunovion Inc. Application No.: 022416 Approval Date: 11/08/2013 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF

2013 FDA - Drug Approval Package

11. Psychiatric and cognitive adverse events: A pooled analysis of three phase III trials of adjunctive eslicarbazepine acetate for partial-onset seizures. Full Text available with Trip Pro

Psychiatric and cognitive adverse events: A pooled analysis of three phase III trials of adjunctive eslicarbazepine acetate for partial-onset seizures. To evaluate the nature and incidence of psychiatric and cognitive adverse events (AEs) reported with eslicarbazepine acetate (ESL) used as adjunctive treatment for refractory partial-onset seizures (POS) in adults.This was a post-hoc analysis of data pooled from three randomized double-blind, placebo-controlled trials (BIA-2093-301, -302, -304

2018 Epilepsy & behavior : E&B

12. Effects of adjunctive eslicarbazepine acetate on neurocognitive functioning in children with refractory focal-onset seizures. Full Text available with Trip Pro

Effects of adjunctive eslicarbazepine acetate on neurocognitive functioning in children with refractory focal-onset seizures. This was a phase-II, randomized, double-blind (DB), placebo-controlled study aimed to evaluate neurocognitive effects of eslicarbazepine acetate (ESL) as adjunctive therapy in pediatric patients with refractory focal-onset seizures (FOS).Children (6-16years old) with FOS were randomized (2:1) to ESL or placebo. Treatment started at 10mg/kg/day, was up-titrated up to 30mg

2018 Epilepsy & behavior : E&B Controlled trial quality: predicted high

13. Tolerability of adjunctive eslicarbazepine acetate according to concomitant lamotrigine or carbamazepine use: A subgroup analysis of three phase III trials in adults with focal (partial-onset) seizures. Full Text available with Trip Pro

Tolerability of adjunctive eslicarbazepine acetate according to concomitant lamotrigine or carbamazepine use: A subgroup analysis of three phase III trials in adults with focal (partial-onset) seizures. To evaluate and compare the effects of concomitant lamotrigine (LTG) or carbamazepine (CBZ) on the incidence of treatment-emergent adverse events (TEAEs) in patients taking adjunctive eslicarbazepine acetate (ESL) for focal (partial-onset) seizures (FS).These post-hoc analyses of data pooled

2018 Epilepsy research

14. Influence of titration schedule and maintenance dose on the tolerability of adjunctive eslicarbazepine acetate: An integrated analysis of three randomized placebo-controlled trials. Full Text available with Trip Pro

Influence of titration schedule and maintenance dose on the tolerability of adjunctive eslicarbazepine acetate: An integrated analysis of three randomized placebo-controlled trials. To examine the influence of titration schedule and maintenance dose on the incidence and type of treatment-emergent adverse events (TEAEs) associated with adjunctive eslicarbazepine acetate (ESL).Data from three randomized, double-blind, placebo-controlled trials were analyzed. Patients with refractory partial-onset

2018 Epilepsy research Controlled trial quality: predicted high

15. Exposure‐safety and efficacy response relationships and population pharmacokinetics of eslicarbazepine acetate Full Text available with Trip Pro

Exposure‐safety and efficacy response relationships and population pharmacokinetics of eslicarbazepine acetate Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED) for focal-onset seizures (FOS). Pharmacokinetic (PK) and pharmacodynamic (PD) models were developed to assess dose selection, identify significant AED drug interactions, and quantitate relationships between exposure and safety and efficacy outcomes from Phase 3 trials of adjunctive ESL.Eslicarbazepine (...) (the primary active metabolite of ESL) population PK was evaluated using data from 1351 subjects enrolled in 14 studies (11 Phase 1 and three Phase 3 studies) after multiple oral doses ranging from 400 to 1200 mg. Population PK and PD models related individual eslicarbazepine exposures to safety outcomes and efficacy responses.Eslicarbazepine PK was described by a one-compartment model with linear absorption and elimination. The probability of a treatment-emergent adverse event (TEAE; dizziness, headache

2018 Acta neurologica Scandinavica Controlled trial quality: uncertain

16. Modeling and simulations to support dose selection for eslicarbazepine acetate therapy in pediatric patients with partial-onset seizures Full Text available with Trip Pro

Modeling and simulations to support dose selection for eslicarbazepine acetate therapy in pediatric patients with partial-onset seizures Modeling and simulations were used to support body weight-based dose selection for eslicarbazepine acetate (ESL) in pediatric subjects aged 4-17 years with partial-onset seizures. A one-compartment pediatric population pharmacokinetic model with formulation-specific first-order absorption, first-order elimination, and weight-based allometric scaling (...) indicated no substantial bias in the overall model and in the accuracy of estimates. The model estimated that concomitant use of carbamazepine or phenobarbital-like AEDs with ESL would decrease the exposure of eslicarbazepine, and that concomitant use of levetiracetam with ESL would increase the exposure of eslicarbazepine, although the small effect of levetiracetam may not represent a true difference. Model-based simulations were subsequently performed to apply target exposure matching of selected ESL

2018 Journal of pharmacokinetics and pharmacodynamics

17. Adjunctive eslicarbazepine acetate: A pooled analysis of three phase III trials. Full Text available with Trip Pro

Adjunctive eslicarbazepine acetate: A pooled analysis of three phase III trials. To assess the safety and efficacy of once-daily (QD) adjunctive eslicarbazepine acetate (ESL).This post-hoc pooled analysis of three randomized, placebo-controlled trials (2093-301, -302, -304) involved adults with refractory partial-onset seizures (POS) receiving 1-3 antiepileptic drugs (AEDs). All studies included 8-week baseline, 2-week titration, and 12-week maintenance periods. Patients were randomized equally

2018 Epilepsy & behavior : E&B

18. Eslicarbazepine acetate in epilepsies with focal and secondary generalised seizures: systematic review of current evidence. (Abstract)

Eslicarbazepine acetate in epilepsies with focal and secondary generalised seizures: systematic review of current evidence. Eslicarbazepine acetate (ESL) is a third-generation antiepileptic drug (AED) approved for adjunctive treatment in adults, children, and adolescents with focal-onset seizures. Recently ESL was approved for initial monotherapy in adults. The intention of this article is to review current evidence for ESL and to summarise its pharmacological profile in comparison to other (...) AEDs of the dibenzazepine group. Areas covered: We performed a systematic literature search in electronic databases (MEDLINE database, Cochrane Central Register of Controlled Trials, Excerpta Medica dataBASE) using a combined search strategy including the following keywords: eslicarbazepine, epilepsy and seizure. The search was performed from 2000 until December 2017. Using a standardised assessment form, information on the study design, methodological framework, data sources and efficacy

2018 Expert review of clinical pharmacology

19. Adjunctive Eslicarbazepine Acetate in Pediatric Patients with Focal Epilepsy: A Systematic Review and Meta-Analysis. (Abstract)

Adjunctive Eslicarbazepine Acetate in Pediatric Patients with Focal Epilepsy: A Systematic Review and Meta-Analysis. In the treatment of pediatric epilepsy, there is a critical demand for effective and safe therapeutic options to address patients' unmet clinical needs. Eslicarbazepine acetate is a novel once-daily antiepileptic drug and a third-generation single enantiomer member of the dibenzazepine family.The objective of this study was to evaluate the efficacy and safety of eslicarbazepine (...) acetate as add-on treatment for focal-onset seizures in pediatric patients using meta-analytical techniques.Randomized, placebo-controlled, single- or double-blinded add-on trials of eslicarbazepine acetate in patients < 18 years of age with focal-onset seizures uncontrolled by concomitant stable antiepileptic drug regimens were identified through a systematic literature search. The assessed outcomes included the mean relative change and ≥ 50% reduction in the baseline seizure frequency, the incidence

2018 CNS drugs

20. Efficacy and safety of eslicarbazepine acetate monotherapy in patients converting from carbamazepine. Full Text available with Trip Pro

Efficacy and safety of eslicarbazepine acetate monotherapy in patients converting from carbamazepine. To evaluate the influence of prior use of carbamazepine (CBZ) and other antiepileptic drugs (AEDs) with a putatively similar mechanism of action (inhibition of voltage-gated sodium channels; VGSCs) on seizure outcomes and tolerability when converting to eslicarbazepine acetate (ESL), using data pooled from 2 controlled conversion-to-ESL monotherapy trials (studies: 093-045, 093-046).Adults

2018 Epilepsia Controlled trial quality: uncertain

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