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Eslicarbazepine

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21. Efficacy and safety of eslicarbazepine acetate versus controlled-release carbamazepine monotherapy in newly diagnosed epilepsy: A phase III double-blind, randomized, parallel-group, multicenter study. (Full text)

Efficacy and safety of eslicarbazepine acetate versus controlled-release carbamazepine monotherapy in newly diagnosed epilepsy: A phase III double-blind, randomized, parallel-group, multicenter study. We assessed the efficacy and safety of once-daily eslicarbazepine acetate in comparison with twice-daily (BID) controlled-release carbamazepine (carbamazepine-CR) monotherapy in newly diagnosed focal epilepsy patients.This randomized, double-blind, noninferiority trial (NCT01162460) utilized (...) a stepwise design with 3 dose levels. Patients who remained seizure-free for the 26-week evaluation period (level A: eslicarbazepine acetate 800 mg/carbamazepine-CR 200 mg BID) entered a 6-month maintenance period. If a seizure occurred during the evaluation period, patients were titrated to the next target level (level B: eslicarbazepine acetate 1200 mg/carbamazepine-CR 400 mg BID, level C: eslicarbazepine acetate 1600 mg/carbamazepine-CR 600 mg BID) and the evaluation period began again. The primary

2018 Epilepsia Controlled trial quality: predicted high

22. Efficacy and safety of eslicarbazepine acetate monotherapy in patients converting from carbamazepine. (Full text)

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

23. Effects of eslicarbazepine on slow inactivation processes of sodium channels in dentate gyrus granule cells. (Full text)

Effects of eslicarbazepine on slow inactivation processes of sodium channels in dentate gyrus granule cells. Pharmacoresistance is a problem affecting ∼30% of chronic epilepsy patients. An understanding of the mechanisms of pharmacoresistance requires a precise understanding of how antiepileptic drugs interact with their targets in control and epileptic tissue. Although the effects of (S)-licarbazepine (S-Lic) on sodium channel fast inactivation are well understood and have revealed maintained

2018 Epilepsia

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

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

25. Adjunctive eslicarbazepine acetate: A pooled analysis of three phase III trials. (Full text)

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

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

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

27. Eslicarbazepine acetate (Zebinix®) 800 mg tablets

Eslicarbazepine acetate (Zebinix®) 800 mg tablets Eslicarbazepine acetate (Zebinix®) 800 mg tablets Eslicarbazepine acetate (Zebinix®) 800 mg tablets All Wales Medicines Strategy Group (AWMSG) Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation All Wales Medicines Strategy Group (AWMSG). Eslicarbazepine acetate (Zebinix®) 800 mg tablets. Penarth: All Wales (...) Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). AWMSG Secretariat Assessment Report Advice No. 3512. 2012 Authors' conclusions Eslicarbazepine acetate (Zebinix®) is recommended as an option for restricted use within NHS Wales. Eslicarbazepine acetate (Zebinix®) should be restricted to treatment of highly refractory patients who remain uncontrolled with, or are intolerant to, other anti-epileptic medicine combinations, within its licensed indication

2012 Health Technology Assessment (HTA) Database.

28. Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions

Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions - GOV.UK GOV.UK uses cookies to make the site simpler. or Search Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions Risk of serious skin-related adverse drug reactions, including Stevens-Johnson syndrome, occurring with carbamazepine may be increased in the presence of the HLA (...) for the treatment of partial seizures with or without secondary generalisation and is closely structurally related to carbamazepine. Eslicarbazepine (Zebinix) is the active metabolite of oxcarbazepine and indicated as adjunctive therapy in adults with partial onset seizures with or without secondary generalisation. It is well-recognised that severe, potentially life-threatening, skin-related adverse drug reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur rarely

2012 MHRA Drug Safety Update

29. Impact of seizure frequency reduction on health-related quality of life among clinical trial subjects with refractory partial-onset seizures: A pooled analysis of phase III clinical trials of eslicarbazepine acetate. (PubMed)

Impact of seizure frequency reduction on health-related quality of life among clinical trial subjects with refractory partial-onset seizures: A pooled analysis of phase III clinical trials of eslicarbazepine acetate. Subjects who received eslicarbazepine acetate (ESL) as adjunctive therapy experienced significantly greater seizure frequency reduction (SFR) than placebo in three phase III, randomized, double-blind trials. This analysis compared changes in health-related quality of life (HRQOL

2017 Epilepsy & behavior : E&B Controlled trial quality: predicted high

30. Eslicarbazepine acetate: its effectiveness as adjunctive therapy in clinical trials and open studies (Full text)

Eslicarbazepine acetate: its effectiveness as adjunctive therapy in clinical trials and open studies Eslicarbazepine acetate (ESL) is a once-daily antiepileptic drug that is approved as adjunctive therapy in adults with focal-onset seizures. Following oral administration, ESL is rapidly metabolized to its active metabolite, eslicarbazepine, which acts primarily by enhancing slow inactivation of voltage-gated sodium channels. The efficacy and safety/tolerability of ESL in the adjunctive setting

2017 Journal of neurology

31. Transition from oxcarbazepine to eslicarbazepine acetate: A single center study (Full text)

Transition from oxcarbazepine to eslicarbazepine acetate: A single center study There is limited clinical evidence for comparison between oxcarbazepine (OXC) and eslicarbazepine acetate (ESL) in terms of tolerability, or how to execute the change from OXC to ESL. We report the process of transitioning patients with focal epilepsy from previous OXC treatment to ESL due to tolerability problems. The rationale for change from OXC is reported, and the outcome with respective to this rationale

2017 Brain and behavior

32. Eslicarbazepine acetate as adjunctive therapy in clinical practice: ESLADOBA study (Full text)

Eslicarbazepine acetate as adjunctive therapy in clinical practice: ESLADOBA study To assess seizure control and tolerability of eslicarbazepine acetate (ESL) as adjunctive therapy to one baseline antiepileptic drug (AED), in adults with partial-onset seizures (POS) with or without secondary generalization.Multicenter, non-interventional, prospective cohort study conducted between March 2012 and September 2014 at 12 neurology departments in Portugal. Adults with POS not controlled with one AED

2017 Acta neurologica Scandinavica

33. Prediction of efficacy for conversion from adjunctive therapy to monotherapy with eslicarbazepine acetate 800 mg once daily for partial-onset epilepsy (Full text)

Prediction of efficacy for conversion from adjunctive therapy to monotherapy with eslicarbazepine acetate 800 mg once daily for partial-onset epilepsy Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED) indicated for partial-onset seizures (POS). Clinical studies of gradual conversion to ESL 1,200 and 1,600 mg QD monotherapies were previously conducted in patients with POS who were not well-controlled by 1 or 2 AEDs. This report describes modeling and simulation (...) of plasma eslicarbazepine (primary active metabolite of ESL) concentrations and time to monotherapy study exit to predict efficacy for conversion to ESL monotherapy at a lower dose of 800 mg, as an option for patients requiring or not tolerating higher doses since this regimen is effective in adjunctive therapy for POS.A previously developed population pharmacokinetic model for ESL monotherapy was used to predict minimum plasma eslicarbazepine concentration (Cmin) in 1,500 virtual patients taking 1 (n

2017 Clinical pharmacology : advances and applications Controlled trial quality: uncertain

34. In Vitro Evaluation of Eslicarbazepine Delivery via Enteral Feeding Tubes (Full text)

In Vitro Evaluation of Eslicarbazepine Delivery via Enteral Feeding Tubes Purpose: The feasibility of preparing an eslicarbazepine acetate suspension using Aptiom tablets for administration via enteral feeding tubes was evaluated. Methods: Eslicarbazepine acetate suspension (40 mg/mL) was prepared using Aptiom tablets after optimizing the tablet crushing methods and the vehicle composition. A stability-indicating high-performance liquid chromatography (HPLC) method was developed to monitor (...) the eslicarbazepine stability in the prepared suspension. Three enteric feeding tubes of various composition and dimensions were evaluated for the delivery of the suspensions. The suspension was evaluated for the physical and chemical stability for 48 hours. Results: The reproducibility and consistency of particle size reduction was found to be best with standard mortar/pestle. The viscosity analysis and physical stability studies showed that ORA-Plus:water (50:50 v/v) was optimal for suspending ability

2017 Hospital pharmacy

35. Euro-Esli: a European audit of real-world use of eslicarbazepine acetate as a treatment for partial-onset seizures (Full text)

Euro-Esli: a European audit of real-world use of eslicarbazepine acetate as a treatment for partial-onset seizures The Euro-Esli study was an exploratory pooled analysis of data from 14 European clinical practice studies, which was conducted to audit the real-world effectiveness, safety, and tolerability of eslicarbazepine acetate (ESL) as an adjunctive treatment for partial-onset seizures. Retention and effectiveness were assessed after 3, 6, and 12 months of ESL treatment, and at the final

2017 Journal of neurology

36. Pooled efficacy and safety of eslicarbazepine acetate as add‐on treatment in patients with focal‐onset seizures: Data from four double‐blind placebo‐controlled pivotal phase III clinical studies (Full text)

Pooled efficacy and safety of eslicarbazepine acetate as add‐on treatment in patients with focal‐onset seizures: Data from four double‐blind placebo‐controlled pivotal phase III clinical studies Pooled evaluation of the key efficacy and safety profile of eslicarbazepine acetate (ESL) added-on to stable antiepileptic therapy in adults with focal-onset seizures.Data from 1703 patients enrolled in four phase III double-blind, randomized, placebo-controlled studies were pooled and analyzed

2017 CNS neuroscience & therapeutics Controlled trial quality: uncertain

37. Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience (Full text)

Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization.The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post (...) -marketing surveillance.We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment

2017 Drug Safety

38. Eslicarbazepine Acetate: A New Improvement on a Classic Drug Family for the Treatment of Partial-Onset Seizures (Full text)

Eslicarbazepine Acetate: A New Improvement on a Classic Drug Family for the Treatment of Partial-Onset Seizures Eslicarbazepine acetate is a new anti-epileptic drug belonging to the dibenzazepine carboxamide family that is currently approved as adjunctive therapy and monotherapy for partial-onset (focal) seizures. The drug enhances slow inactivation of voltage-gated sodium channels and subsequently reduces the activity of rapidly firing neurons. Eslicarbazepine acetate has few, but some, drug (...) -drug interactions. It is a weak enzyme inducer and it inhibits cytochrome P450 2C19, but it affects a smaller assortment of enzymes than carbamazepine. Clinical studies using eslicarbazepine acetate as adjunctive treatment or monotherapy have demonstrated its efficacy in patients with refractory or newly diagnosed focal seizures. The drug is generally well tolerated, and the most common side effects include dizziness, headache, and diplopia. One of the greatest strengths of eslicarbazepine acetate

2017 Drugs in R&D

39. Incidence of seizure exacerbation and seizures reported as adverse events during adjunctive treatment with eslicarbazepine acetate: A pooled analysis of three Phase III controlled trials (Full text)

Incidence of seizure exacerbation and seizures reported as adverse events during adjunctive treatment with eslicarbazepine acetate: A pooled analysis of three Phase III controlled trials To investigate whether adjunctive eslicarbazepine acetate (ESL) could lead to exacerbation of seizures in some patients.Post-hoc analysis of data pooled from three Phase III trials of adjunctive ESL (studies 301, 302, and 304) for refractory partial-onset seizures (POS). Following an 8-week baseline period

2017 Epilepsia Open Controlled trial quality: uncertain

40. Development of a stress induced validated UPLC-PDA method for the analysis of Eslicarbazepine acetate (Full text)

Development of a stress induced validated UPLC-PDA method for the analysis of Eslicarbazepine acetate 30166930 2018 11 14 1319-0164 26 2 2018 Feb Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society Saudi Pharm J Development of a stress induced validated UPLC-PDA method for the analysis of Eslicarbazepine acetate. 286-291 10.1016/j.jsps.2017.11.009 Iram Farah F Department of Pharmaceutical Chemistry, School of Pharmaceutical Education and Research

2017 Saudi Pharmaceutical Journal : SPJ

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