Latest & greatest articles for levetiracetam

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Top results for levetiracetam

1. Levetiracetam versus phenytoin for second-line treatment of paediatric convulsive status epilepticus (EcLiPSE): a multicentre, open-label, randomised trial. (Full text)

Levetiracetam versus phenytoin for second-line treatment of paediatric convulsive status epilepticus (EcLiPSE): a multicentre, open-label, randomised trial. Phenytoin is the recommended second-line intravenous anticonvulsant for treatment of paediatric convulsive status epilepticus in the UK; however, some evidence suggests that levetiracetam could be an effective and safer alternative. This trial compared the efficacy and safety of phenytoin and levetiracetam for second-line management (...) of paediatric convulsive status epilepticus.This open-label, randomised clinical trial was undertaken at 30 UK emergency departments at secondary and tertiary care centres. Participants aged 6 months to under 18 years, with convulsive status epilepticus requiring second-line treatment, were randomly assigned (1:1) using a computer-generated randomisation schedule to receive levetiracetam (40 mg/kg over 5 min) or phenytoin (20 mg/kg over at least 20 min), stratified by centre. The primary outcome was time

2019 Lancet PubMed

2. Levetiracetam versus phenytoin for second-line treatment of convulsive status epilepticus in children (ConSEPT): an open-label, multicentre, randomised controlled trial. (PubMed)

Levetiracetam versus phenytoin for second-line treatment of convulsive status epilepticus in children (ConSEPT): an open-label, multicentre, randomised controlled trial. Phenytoin is the current standard of care for second-line treatment of paediatric convulsive status epilepticus after failure of first-line benzodiazepines, but is only effective in 60% of cases and is associated with considerable adverse effects. A newer anticonvulsant, levetiracetam, can be given more quickly, is potentially (...) more efficacious, and has a more tolerable adverse effect profile. We aimed to determine whether phenytoin or levetiracetam is the superior second-line treatment for paediatric convulsive status epilepticus.ConSEPT was an open-label, multicentre, randomised controlled trial conducted in 13 emergency departments in Australia and New Zealand. Children aged between 3 months and 16 years, with convulsive status epilepticus that failed first-line benzodiazepine treatment, were randomly assigned (1:1

2019 Lancet

3. [ANZEN]PMDA Risk Communication: Levetiracetam, etc. posted

[ANZEN]PMDA Risk Communication: Levetiracetam, etc. posted PMDA Risk Communications | Pharmaceuticals and Medical Devices Agency Please make JavaScript on and see this site. Navigation of each product type Our recommended contents Navigation of each product type Our recommended contents PMDA Risk Communications Here begins the text. PMDA Risk Communications Drug Risk Information of Ongoing Evaluation This webpage was developed to provide drug risk information which has come under review

2019 Pharmaceuticals and Medical Devices Agency, Japan

4. Phenytoin versus levetiracetam as prophylaxis for postcraniotomy seizure in patients with no history of seizures: systematic review and meta-analysis

Phenytoin versus levetiracetam as prophylaxis for postcraniotomy seizure in patients with no history of seizures: systematic review and meta-analysis OBJECTIVEDe novo seizure following craniotomy (DSC) for nontraumatic pathology may adversely affect medical and neurological outcomes in patients with no history of seizures who have undergone craniotomies. Antiepileptic drugs (AEDs) are commonly used prophylactically in patients undergoing craniotomy; however, evidence supporting this practice (...) is limited and mixed. The authors aimed to collate the available evidence on the efficacy and tolerability of levetiracetam monotherapy and compare it with that of the classic AED, phenytoin, for DSC.METHODSPubMed, Embase, Web of Science, and the Cochrane Library were searched for studies that compared levetiracetam with phenytoin for DSC prevention. Inclusion criteria were adult patients with no history of epilepsy who underwent craniotomy with prophylactic usage of phenytoin, a comparator group

2018 EvidenceUpdates

5. Levetiracetam

Levetiracetam Top results for levetiracetam - Trip Database or use your Google+ account Liberating the literature ALL of these words: Title only Anywhere in the document ANY of these words: Title only Anywhere in the document This EXACT phrase: Title only Anywhere in the document EXCLUDING words: Title only Anywhere in the document Timeframe: to: Combine searches by placing the search numbers in the top search box and pressing the search button. An example search might look like (#1 or #2 (...) ) and (#3 or #4) Loading history... Population: Intervention: Comparison: Outcome: Population: Intervention: Latest & greatest articles for levetiracetam The Trip Database is a leading resource to help health professionals find trustworthy answers to their clinical questions. Users can access the latest research evidence and guidance to answer their clinical questions. We have a large collection of systematic reviews, clinical guidelines, regulatory guidance, clinical trials and many other forms

2018 Trip Latest and Greatest

6. Levetiracetam versus phenytoin for seizure prophylaxis during and early after craniotomy for brain tumours: a phase II prospective, randomised study (PubMed)

Levetiracetam versus phenytoin for seizure prophylaxis during and early after craniotomy for brain tumours: a phase II prospective, randomised study Phenytoin (PHT) is routinely used for seizure prophylaxis in patients with brain tumours during and after craniotomy, despite incomplete evidence. We performed a prospective, randomised study to investigate the significance of prophylactic use of levetiracetam (LEV), in comparison with PHT, for patients with supratentorial tumours

2015 EvidenceUpdates

7. Levetiracetam

Levetiracetam USE OF LEVETIRACETAM IN PREGNANCY 0344 892 0909 USE OF LEVETIRACETAM IN PREGNANCY (Date of issue: December 2014 , Version: 2.2 ) This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a . Please encourage all women to complete an . A corresponding patient information leaflet on is available at . Summary Levetiracetam is an anticonvulsant used either (...) in monotherapy or as adjunctive therapy of focal seizures with or without secondary generalisation, and for adjunctive therapy of myoclonic seizures in juvenile myoclonic epilepsy and primary generalised tonic-clonic seizures. Overall congenital malformation rates have been studied in approximately 1,300 infants gestationally exposed during the first trimester to levetiracetam monotherapy, with no evidence of any increased risk, although in some cases study methodologies limit conclusions. A single study

2014 UK Teratology Information Service

8. Levetiracetam Hospira

Levetiracetam Hospira 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail info@ema.europa.eu Website www.ema.europa.eu © European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. 24 October 2013 EMA/777160/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Levetiracetam Hospira International non-proprietary name (...) : LEVETIRACETAM Procedure No. EMEA/H/C/002783/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/777160/2013 Page 2/16 Table of contents 1. Background information on the procedure 3 1.1. Submission of the dossier 3 Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible. 3 Information relating to orphan market exclusivity 4 1.2. Manufacturers 5 1.3. Steps

2014 European Medicines Agency - EPARs

9. A cost-minimization analysis of phenytoin versus levetiracetam for early seizure pharmacoprophylaxis after traumatic brain injury

A cost-minimization analysis of phenytoin versus levetiracetam for early seizure pharmacoprophylaxis after traumatic brain injury A cost-minimization analysis of phenytoin versus levetiracetam for early seizure pharmacoprophylaxis after traumatic brain injury A cost-minimization analysis of phenytoin versus levetiracetam for early seizure pharmacoprophylaxis after traumatic brain injury Pieracci FM, Moore EE, Beauchamp K, Tebockhorst S, Barnett CC, Bensard DD, Burlew CC, Biffl WL, Stoval RT (...) , Johnson JL Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study examined the clinical and economic impact of levetiracetam, compared with phenytoin, to prevent early seizures after traumatic brain injury. The authors concluded

2013 NHS Economic Evaluation Database.

10. The use of Levetiracetam and Phenytoin for Seizure Prophylaxis in the Setting of Severe Traumatic Brain Injury

The use of Levetiracetam and Phenytoin for Seizure Prophylaxis in the Setting of Severe Traumatic Brain Injury "The use of Levetiracetam and Phenytoin for Seizure Prophylaxis in the " by Gregg V. Kosloff < > > > > > Title Author Date of Graduation Summer 8-11-2012 Degree Type Capstone Project Degree Name Master of Science in Physician Assistant Studies First Advisor Mark Pedemonte, MD Second Advisor Annjanette Sommers, PA-C, MS Rights . Abstract Background: Each year in the United States (...) an estimated 1.7 million people suffer a traumatic brain injury (TBI). Current standard of care for these patients is seven days of phenytoin (PHT) for seizure prophylaxis. Given the known side effect profile and drug interactions associated with the use of PHT, levetiracetam (LEV) has been proposed as an alternative for seizure prophylaxis. This systematic review examined available literature to determine whether or not there is sufficient evidence to recommend the use of LEV in lieu of PHT. Method

2012 Pacific University EBM Capstone Project

11. Levetiracetam in Sodium Chloride Injection

Levetiracetam in Sodium Chloride Injection Drug Approval Package: Levetiracetam NDA #202543 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/ 100 mL, and 1500 mg/100 mL Company: H Q Specialty Pharma Corporation Application No.: 202543 Approval Date: 11/09/2011 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF

2011 FDA - Drug Approval Package

12. Levetiracetam Accord

Levetiracetam Accord 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. London, 21 July 2011 EMA767403/2011 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report Levetiracetam Accord International non proprietary (...) name: levetiracetam Procedure No. EMEA/H/C/002290 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted Levetiracetam Accord CHMP assessment report EMA/CHMP/510861/2011 Page 2/20 Table of contents 1 5 Background information on the procedure 1.1 5 Submission of the dossier 1.2 6 Steps taken for the assessment of the product 2 7 Scientific discussion 2.1 7 Introduction 2.2 8 Quality aspects 2.2.1 8 Introduction 2.2.2 8 Active Substance 2.2.3 9

2011 European Medicines Agency - EPARs

13. Levetiracetam Actavis Group

Levetiracetam Actavis Group 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. London, 22 September 2011 EMA/884675/2011 Committee for Medicinal Products for Human Use (CHMP) Assessment report Levetiracetam Actavis Group International (...) nonproprietary name: Levetiracetam Procedure No. EMEA/H/C/2305 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Levetiracetam Actavis Group Assessment report EMA/884675/2011 Page 2/15 Table of contents 1 5 Background information on the procedure 1.1 5 Submission of the dossier 1.2 6 Steps taken for the assessment of the product 2 7 Scientific discussion 2.1 7 Introduction 2.2 8 Quality aspects 2.2.1 8 Introduction 2.2.2 8 Active Substance 2.2.3

2011 European Medicines Agency - EPARs

14. Levetiracetam Actavis

Levetiracetam Actavis 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. London, 21 July 2011 EMA/817944/2011 Committee for Medicinal Products for Human Use (CHMP) Assessment report Levetiracetam Actavis International nonproprietary name (...) : Levetiracetam Procedure No. EMEA/H/C/002355 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Table of contents 1 5 Background information on the procedure 1.1 5 Submission of the dossier Scientific Advice 6 Licensing status 6 1.2 6 Manufacturers 1.3 6 Steps taken for the assessment of the product 2 8 Scientific discussion 2.1 8 Introduction 2.2 8 Quality aspects 2.2.1 8 Introduction 2.2.2 9 Active Substance 2.2.3 10 Finished Medicinal Product

2011 European Medicines Agency - EPARs

15. Levetiracetam Sun

Levetiracetam Sun 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union London, 20 October 2011 EMA/CHMP/657653/2011 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report Levetiracetam SUN International non-proprietary name: levetiracetam Procedure No.: EMEA/H/C/002051 Product information Marketing authorisation (...) application Name of the medicinal product: Levetiracetam SUN Applicant: Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 NL-2132 JH Hoofddorp The Netherlands Active substance: Levetiracetam International Nonproprietary Name: Levetiracetam Pharmaco-therapeutic group (ATC Code): Other antiepileptics (N03AX14) Therapeutic indication(s): Levetiracetam SUN is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age

2011 European Medicines Agency - EPARs

16. Levetiracetam ratiopharm

Levetiracetam ratiopharm 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union 19 May 2011 EMA/CHMP/318321/2011 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report Levetiracetam ratiopharm International non proprietary name: levetiracetam Procedure No. EMEA/H/C/002244 Assessment Report as adopted by the CHMP (...) with all information of a commercially confidential nature deleted. Levetiracetam ratiopharm CHMP assessment report EMA/CHMP/318321/2011 Page 2/20 Table of contents 1. Background information on the procedure 3 1.1. Submission of the dossier 3 1.2. Steps taken for the assessment of the product 4 2. Scientific discussion 6 2.1. Introduction 6 2.2. Quality aspects 6 2.2.1. Introduction 6 2.2.2. Active Substance 7 2.2.3. Finished Medicinal Product 8 2.2.4. Discussion on chemical, and pharmaceutical aspects

2011 European Medicines Agency - EPARs

17. Levetiracetam Teva

Levetiracetam Teva 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged. London, 19 May 2011 EMA/457042/2011 Committee for Medicinal Products for Human Use (CHMP) Assessment report Levetiracetam Teva International non proprietary name (...) : levetiracetam Procedure No. EMEA/H/C/002316 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted. Table of contents 1. Background information on the procedure 3 1.1. Submission of the dossier 3 1.2. Steps taken for the assessment of the product 4 2. Scientific discussion 4 2.1. Introduction 4 2.2. Quality aspects 5 2.3. Non- Clinical aspects 9 2.4. Clinical Aspects 10 2.5. Pharmacovigilance 18 2.6. User consultation 18 3. Benefit-Risk Balance 18 4

2011 European Medicines Agency - EPARs

18. Matever - levetiracetam

Matever - levetiracetam 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union 21 July2011 EMA/CHMP/323600/2011 Committee for Medicinal Products for Human Use (CHMP) Assessment report Matever International nonproprietary name: levetiracetam Procedure No. EMEA/H/C/2024 Assessment Report as adopted by the CHMP with all information (...) substance levetiracetam. The applicant initially applied also for the oral solution but withdrew this pharmaceutical form during the evaluation process. The reference medicinal product is Keppra as film-coated tablets, oral solution and concentrate for solution for infusion authorised on 29 September 2000. Levetiracetam is a chemical entity related to piracetam, a nootropic drug. Initial research was directed primarily towards indications where piracetam and piracetam-like compounds had shown

2011 European Medicines Agency - EPARs

19. Cost-effectiveness analysis of intravenous levetiracetam versus intravenous phenytoin for early onset seizure prophylaxis after neurosurgery and traumatic brain injury (Full text)

Cost-effectiveness analysis of intravenous levetiracetam versus intravenous phenytoin for early onset seizure prophylaxis after neurosurgery and traumatic brain injury Cost-effectiveness analysis of intravenous levetiracetam versus intravenous phenytoin for early onset seizure prophylaxis after neurosurgery and traumatic brain injury Cost-effectiveness analysis of intravenous levetiracetam versus intravenous phenytoin for early onset seizure prophylaxis after neurosurgery and traumatic brain (...) injury Kazerooni R, Bounthavong M Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study examined the cost-effectiveness of intravenous levetiracetam, compared with conventional intravenous phenytoin, as prophylaxis against seizures

2010 NHS Economic Evaluation Database. PubMed

20. Levetiracetam for the treatment of idiopathic generalized epilepsy with myoclonic seizures (PubMed)

Levetiracetam for the treatment of idiopathic generalized epilepsy with myoclonic seizures Currently, there are no published randomized controlled trials evaluating the efficacy and safety of adjunctive antiepileptic therapy in idiopathic generalized epilepsy with myoclonic seizures.This randomized, double-blind, placebo-controlled multicenter trial assessed the efficacy and tolerability of adjunctive treatment with levetiracetam 3,000 mg/day in adolescents (>or=12 years) and adults (or=8 days during a prospective 8-week baseline period, despite antiepileptic monotherapy. The 8-week baseline period was followed by 4-week up-titration, 12-week evaluation, and 6-week down-titration/conversion periods.Of 122 patients randomized, 120 (levetiracetam, n = 60; placebo, n = 60) were evaluable. Diagnoses were either juvenile myoclonic epilepsy (93.4%) or juvenile absence epilepsy (6.6%). A reduction

2008 EvidenceUpdates