EpIc
Multicenter, Comparative, Randomized, Open Trial to Evaluate Efficacy and Safety of Levetiracetam Versus Carbamazepine in Post Stroke Late Onset Crisis
Sponsor study identifier
interventional
630
1 country
24
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The principal purpose of the study is to determine the efficacy and safety of Levetiracetam versus Carbamazepine, intended as the number of patients free from crisis during the whole period of treatment, in patients affected by post stroke late onset crisis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
October 11, 2007
Actual (reported)October 12, 2007
Actual (reported)June 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
number of patients free from post stroke recurrent crisis
one year
To compare retention time of LEV vs CBZ since first intake throughout treatment period
one year
To compare time to second seizure in both treatments.
one year
To evaluate differences in cognitive function and in quality of life in levetiracetam and carbamazepine patients having post-stroke seizures at the end of treatment period
one year
evaluate EEG changes as compared with baseline with that obtained at the end of treatment period
one year
To compare seizure frequency in levetiracetam and carbamazepine groups throughout treatment period
one year
Levetiracetam
Carbamazepina
Levetiracetam tablets 250-500 mg. The drug dosage will be up-titrated from 250 mg bid in the first 2 weeks to 500 mg bid during the rest of the treatment period. The dosage can be incremented until 1500 mg bid, at Investigator judgement if crisis continue, or it can be reduced in case of adverse events
Carbamazepina tablets 200 mg. The drug dosage will be up-titrated from 100 mg die in the first 3 days to 100 mg bid during days 4 to 7, to 200 mg bid in the 2nd week, to 300 mg bid during the rest of the treatment period. The dosage can be incremented until 800 mg bid, at Investigator judgement if crisis continue, or it can be reduced in case of adverse events
Ospedale S. Giacomo
Novi Ligure, AL, 15057, Italy
Ospedale S. Croce E Carle
Cuneo, CN, 12100, Italy
Ospedale S. Martino
Genova, GE, 16132, Italy
Silverman IE, Restrepo L, Mathews GC. Poststroke seizures. Arch Neurol. 2002 Feb;59(2):195-201. doi: 10.1001/archneur.59.2.195.
Stephen LJ, Brodie MJ. Epilepsy in elderly people. Lancet. 2000 Apr 22;355(9213):1441-6. doi: 10.1016/S0140-6736(00)02149-8.
Inzitari D. The Italian Guidelines for stroke prevention. The Stroke Prevention and Educational Awareness Diffusion (SPREAD) Collaboration. Neurol Sci. 2000 Feb;21(1):5-12. doi: 10.1007/s100720070112. No abstract available.
domenico consoli, doctor
Ospedale Civile Vibo Valentia
First Submitted
October 11, 2007
First Posted
October 12, 2007
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2009
Estimated (date passed)Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Istituto Clinico Humanitas
Rozzano, MI, 20089, Italy
USL 2 Ospedale B.G. Villa
Città della Pieve, PG, 06062, Italy
Ospedale Civile San Giovanni Battista di Foligno
Foligno, PG, Italy
Ospedale Santa Maria della Misericordia
Sant'Andrea Delle Fratte, PG, 06131, Italy
Istituto Neurologico C. Mondino
Pavia, PV, 27100, Italy
Ospedale Guzzardi
Vittoria, RG, 97019, Italy
Ospedale Di Portogruaro
Portogruaro, VE, 30026, Italy
Ospedale Civile
Vibo Valentia, VV, 89900, Italy
Policlinico Umberto I
Ancona, 60020, Italy
Ospedale A. Perrino
Brindisi, 72100, Italy
Ospedale Cannizzaro
Catania, 95126, Italy
Ospedale San Martino
Genova, Italy
Ospedale Civile Imperia ASL 1
Imperia, 18100, Italy
Ospedale A. Cardarelli-
Naples, 80131, Italy
Ospedale Cardarelli
Naples, 80131, Italy
Ospedale Civico
Palermo, 90100, Italy
Osp. Guglielmo da saliceto
Piacenza, 29100, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, 42100, Italy
Ospedale SS. Annunziata - Ospedale Civile
Taranto, Italy
Ospedale Molinette-Università di Torino
Torino, Italy
Azienda Ospedaliera Universitaria Trieste
Trieste, 34149, Italy
Hauser WA, Annegers JF, Kurland LT. Incidence of epilepsy and unprovoked seizures in Rochester, Minnesota: 1935-1984. Epilepsia. 1993 May-Jun;34(3):453-68. doi: 10.1111/j.1528-1157.1993.tb02586.x.
Bladin CF, Alexandrov AV, Bellavance A, Bornstein N, Chambers B, Cote R, Lebrun L, Pirisi A, Norris JW. Seizures after stroke: a prospective multicenter study. Arch Neurol. 2000 Nov;57(11):1617-22. doi: 10.1001/archneur.57.11.1617.
Rhoney DH, Tipps LB, Murry KR, Basham MC, Michael DB, Coplin WM. Anticonvulsant prophylaxis and timing of seizures after aneurysmal subarachnoid hemorrhage. Neurology. 2000 Jul 25;55(2):258-65. doi: 10.1212/wnl.55.2.258.
Olafsson E, Gudmundsson G, Hauser WA. Risk of epilepsy in long-term survivors of surgery for aneurysmal subarachnoid hemorrhage: a population-based study in Iceland. Epilepsia. 2000 Sep;41(9):1201-5. doi: 10.1111/j.1528-1157.2000.tb00326.x.
Berger AR, Lipton RB, Lesser ML, Lantos G, Portenoy RK. Early seizures following intracerebral hemorrhage: implications for therapy. Neurology. 1988 Sep;38(9):1363-5. doi: 10.1212/wnl.38.9.1363.
Sung CY, Chu NS. Epileptic seizures in thrombotic stroke. J Neurol. 1990 Jun;237(3):166-70. doi: 10.1007/BF00314589.
- Birnstiel S., Wulfert E., Beck SG., Levetiracetam (ucb L059) affects in vitro model of epilepsy in CA3 pyramidal neurons without altering normal synaptic transmission. Naunyn Schiemeberg Arch Pharmacol 1997: 356:611-618 - Bischoff U. And Schlobohm I. - Levetiracetam Has No Effect On Voltage-Gated Potassium Currents In Cultured Mouse Hippocampal Neurons. Epilepsia 43(Suppl. 8):88, 2002. - Blais L, Sheehy O, St-Hilaire JM, Bernier JP, Godfroid P, Le Lorier J. Economic evaluation of levetiracetam as adjunctive therapy in refractory epileptic patients. Value in Health 2002;5(6):509 - Boon P, Chauvel P, Pohlmann-Eden B, Otoul C, Wroe S. Dose-response effect of levetiracetam 1000 and 2000 mg/day in partial epilepsy. Epilepsy Research 2002;48:77-89
- Castillo et al., Cochrane Database Syst Rev 2000;(3):CD 002028 - Chadwick et al., Cochrane Database Syst Rev 2002;(2):CD 001416 - Chaisewikul et al., Cochrane Database Syst Rev 2001;(1):CD 001901 - Coupez R., Nicolas JM, Browne TR Levetiracetam, a new antiepileptic agent: lack of in vitro and in vivo pharmacokinetic interaction with phenytoin in patient with valproic acid. Epilepsia 2003;44:171-178 - Cramer JA, Arrigo C, Van Hammee G, Gauer LJ, Cereghigno JJ. Effect of levetiracetam on epilepsy-related quality of life. Yhe N132 study group. Epilepsia 2000;41:868-874 - Cramer JA, Van Hammee G, N132 study Group. Maintenance of improvement in health-related quality of life during long-term treatment with levetiracetam. Epilepsy Behav 2003;4:118-123
- Cramer J, De Rue K, Devinsky O, Edrich P, Trimble MR. A systematic review of the behavioral effects of levetiracetam in adults with epilepsy, cognitive disorder or an anxiety disorder during clinical trial. Epilepsy Behav. 2003;4:124-132 - Cramer JA, Ben-Menachem E, Franch J. Review of treatment options for refractory epilepsy: new medications and vagal nerve stimulation. Epilepsy Research 2001;47:17-25 - Cramer J.A., Leppik I.E., De Rue K., Eldrich P., Kramer G. - Tolerability of levetiracetam in elderly patients with CNS disorders - Epilepsy Research 2003; 56:135-145 - Devinsky O, Elger C. Efficacy of levetiracetam in partial seizure. Epileptic Disorder 2003;5(suppl 1):S27-S32
- Ferrendelli J.A., French J., Leppik., Morrel M.J., Herbeuval A., Han J., Magnus L. - Use of levetiracetam in a population of patients aged 65 years and older: a subset analysis of the KEEPER trial - Epilepsy & Behavior 2003; 4:702-709 - French J, Edrich P, Cramer JA. A systematic review of safety profile of levetiracetam: a new antiepileptic drug. Epilepsy Res 2001;47:77-90 - Fucks B, Gillard M, Michel P, Lynch B, Vertongen P, Leprince P, Klitgaard H, Chatelain P. - Localisation and photoaffinity labelling of the levetriacetam dinding site in rat brain and certain cell lines Eur. J. Pharmacol 2003; 478, 11-19 - Gillard M, Fucks B, Michel P, Vertongen P, Massingham R, Chatelain P Binding characteristich of [3H]ucb 30889 to levetiracetam binding sites in rat brain Eur J Phamacol 2003; 478: 1-9
- Giuliano RA, Hiersemenzel R, Baltes E, et al Influence of new antiepileptic drug (levetiracetam ucb L057) on the pharmacokinetics and pharmacodynamics of oral contraceptives Epilepsia 1996; 37 (Suppl.4):90 - Glauser TA, Pellock JM, Bebin EM. Efficacy and safety of levetiracetam in children with partial seizure: an open label trial. Epilepsia 2002;43:518-524 - Glauser TA, Dulac O. Preliminary efficacy of levetiracetam in children. Epileptic Disorder 2003;5(suppl 1):S45-S50 - Godfroid P, Hart Y, Roberts R, Le Lorier J. Seizure freedom in patients treated with adjunctive levetiracetam: economic evaluation within the NHS. Neurology 2003;60(S1):A433-A434 - Gower AJ, Hirsch E, Boehrer A, et al. Effects of levetiracetam, a novel antiepileptic drug on convulsant activity in two genetic rat models of epilepsy Epilepsy Research 1995; 22: 207-13
- Gower AJ, Noyer M, Verloes R., et al. ucb L059, a novel anti-convulsant drug: pharmacological profle in animals. Eur J Pharmacol. 1992; 222: 193-203 - Gu J., Lynch B. A., Anderson D., Klitgaard H., Lu s., Elashoff M., Ebert U., Potschka H. - Loscher W. - The antiepileptic drug levetiracetam selectively modifies kindling-induced alterations in gene expression in the temporal lobe of rats. - European Journal of Neuroscience Vol. 19, pp334-345, 2004 - Kastelain-Nolst Trenitè DGA, Hirsch E. Levetiracetam: preliminary efficacy in generalised seizure. Epileptic Disorder 2003;5(suppl 1):S39-S44 - Klitgaard H, Matagne A, Gobert M, Michel P Evidence for a unique profile of levetiracetam in rodent models of seizures and epilepsy Eur. J. Pharmacology 1998; 353: 191-206
- Klitgaard H, Pitkanen A, Antiepileptogenesis, neuroprotection, and disease modification in the treatment of epilepsy: focus on levetiracetam. Epileptic disorder 2003; 5:S9-S16 - Kraemer G, Eldrich P. Levetiracetam in Elderly patients with epilepsy - The American Eplepsy Society and The American Clinical Neurophysiology Society - Joint Meeting November 30-December 5, 2001 - Krakow K, Walker M, Otoul C, Sander JWAS. Long-term continuation of Levetiracetam in patients with refractory epilepsy. Neurology 2001;56:1772-1774 - Krauss GL, Abou-khalil B, Sheth SG. Efficacy of levetiracetam for treatment fo drug-resistant generalised epilepsy. Epilepsia 2001;42(suppl 7):181 - Krauss GL, Betts T, Abou-Khalil B, Bergey G, Yarrow H, Miller A. Levetiracetam treatment of idiopathic generalised epilepsy. Seizure 2003;12:617-620
- Lagae L, Buyse G, Deconinck A, Ceulemans B. Effect of levetiracetam in refractory childhood epilepsy syndromes. Eur J Paediatric Neurol 2003;7:123-128 - Levy RH, Raguenau-Majlessi I, Baltes E Repeated administration of the novel antiepileptic agent levetiracetam does not alter digoxin pharmacokinetics and pharmacodynamics in healthy volunteers Epilepsy Research 2001; 47: 55-63 - Loscher W, Honak D, Rundfeld C Antiepileptogenic effect of the novel anticonvulsant levetiracetam (ucb L059) in the kindling model of temporal lobe epilepsy. - J. Pharmacological Exp. Ther 1998; 284: 474-9 - Lukyanetz EA, Shkryl VM, Kostyuk PG Selective blockade of N-type Calcium Channels by levetiracetam Epilepsia 2002; 43(1): 9-18 - Madeja M., Margineanu D.G., Gorji A., Siep E., Boerrigter P., Klitgaard H., Et Al.
- Madeja M., Margineanu D.G., Gorji A., Siep E., Boerrigter P., Klitgaard H., Et Al. Reduction Of Voltage-Operated Potassium Currents By Levetiracetam: A Novel Antiepileptic Mechanism Of Action? - Neuropharmacology Oct-2003. 45(5):661-671. - Margineau D. G., Klitgaard Henrik Levetiracetam - Mechanism of action - Antiepilectic drugs, 5th edition. Edited by R.H. Levy, R.H. Mattson, B.S. Meldrum, and E.Perucca. Philadelphia: Lippincott Williams & Wilkins, 2002 - Margineau DG, Klitgaard H Inhibition of neural hyperynchrony in vitro differentiates levetiracetam fro classical antiepileptic drugs Pharmacol. Research 2000; 42(4): 281-285 - Marson AG, Hutton JL, Leach JP. Levetiracetam, Oxcarbazepine, Remacemide and zonisamide for drug resistant localization-related epilepsy: a systematic review. Epilepsy Res 2001;46:259-270
- Marson AG, Kadir ZA, Hutton JL, Chadwick DW. The new antiepileptic drugs: a systematic review of their efficacy and tolerability. Epilepsia 1997;38:859-880 - Morrell MJ, Leppik I, French J, Ferrendelli J, Han J, Magnus L. The KEEPER trial: levetiracetam adjunctive treatment of partial-onset seizure in an open-label community-based study. Epilepsy Res 2003;54:153-161 - Niespodziany I, Klitgaard H, Margineau DG Desynchronizing effect of levetiracetam on epileptiform responses in rat hippocampal slices Neuropharmaology Neuroreport 2003; vol14(9): 1273-1276 - Noyer M, Gillard M, Magagne A., et al. The novel antiepileptic drug levetiracetam (ucb L059) appears o act via a specific binding site in CNS membranes. Eur J Pharmacol 1995 ; 286 : 137-146 - Patsalos PN Pharmacokinetic profile of levetiracetam: toward ideal characteristics. Pharmacol. Ther 2000; 83: 77-85 - Patsalos PN The pharmacokinetic characteristics of levetiracetam. Method Find. Exp. Clinic Pharmacol. 2003; 25: 123-129
- Perucca E, Johannessen SI The ideal pharmacokinetic properties of an antiepileptic drug: how close does levetiracetam come? Epileptic Disorder 2003; 5(suppl 1):S17-S26 - Perucca E. Pharmacokinetics. In:Engel J Jr, Pedley TA Epilepsy-A comprehensive Textbook. New York: Raven Press 1997:1131-1153 - Radtke RA Pharmacokinetics of levetiracetam Epilepsia 2001; 42(Suppl 4):24-7 - Raguenau-Majlessi I, Levy RH, Meyerhoff C Lack of effect of repeated administration of levetiracetam on the pharmacodynamics and pharmakinetic profile of warfarin Epilepsy Res 2001; 47: 55-63 - Rigo JM, Hans G, Nguyen L, et al. The antiepileptic drug levetiracetam reverses the inhibition by negative allosteric modulators of neuronal GABA - and Glycine-gated current. Br J Pharmacol 2002; 136:659-72 - Sadek AH, Fix A, French J. Levetiracetam related behavioural adverse events: a post-marketing study. Epilepsia, 2002;43S8:151
- Shorvon SD, Van Rijckevorsel. A new antiepileptic drug Levetiracetam, a pyrrolidone recently licensed as an antiepileptic drug. J Neurol Neurosurg Psychiatry 2002 ;72: 426-429 - Smith K, Betts T, Pritchett L. Levetiracetam, a promising option for the treatment of juvenile myoclonic epilepsy. Epilepsia 2000;41(suppl1):39 - Van Rijckevorsel K. The " number needed to treat " with levetiracetam : comparison with the other new antiepileptic drugs. Seizure 2001;10:235-236 - Welty TE, Gidal BE, Ficker DM, Privitera MD. Levetiracetam: a different approach to the pharmacotherapy of epilepsy. The Annals of Pharmacotherapy 2002;36:296-304 - Zona C, Niespodziany I, Marchetti C, et al. Levetiracetam does not modulate neuronal voltage-gated Na+ and T-type Ca2+ currents. Seizure 2001; 10: 279-86
- Grigoletto Francesco, Zappalà Giuseppe, Anderson Dallas W., Lebowitz Barry D. Norms for the Mini.-Mental State Examination in a Healthy population. Neurology 1999;53:315-320 - Measso G., Zappalà G., Cavarzeran F, Crook TH, Romani L, Pirozzolo FJ, Grigoletto F., Amaducci LA, Lebowitz BD. Raven's colored progressive matrices: a normative study of a random sample of healthy adults. Acta Neurol. Scandinavica 1993:88:70-74 - Spinnler Hans & Tognoni Gianni Standardizzazione e taratura Italiana di Test Neuropsicologici Suppl. 8/to n.6 1987 The Italian Journal of Neurological Sciences - Zappalà G. Measso G., Cavarzeran F. Grigoletto F., Lebowitz B., Pirozzolo F., Amaducci L., Massari D., and Crook T. Aging and memory: corrections for age, sex and education fro three widely used memory tests - Italian Journal Of Neurological Sciences 1995;16: 177-184
Ben-Menachem E, Falter U. Efficacy and tolerability of levetiracetam 3000 mg/d in patients with refractory partial seizures: a multicenter, double-blind, responder-selected study evaluating monotherapy. European Levetiracetam Study Group. Epilepsia. 2000 Oct;41(10):1276-83. doi: 10.1111/j.1528-1157.2000.tb04605.x.
Angehagen M, Margineanu DG, Ben-Menachem E, Ronnback L, Hansson E, Klitgaard H. Levetiracetam reduces caffeine-induced Ca2+ transients and epileptiform potentials in hippocampal neurons. Neuroreport. 2003 Mar 3;14(3):471-5. doi: 10.1097/00001756-200303030-00035.
- Arroyo S, Crawford P. Safety profile of levetiracetam. Epileptic Disorder 2003;5S1:S57-S63 - Ben-Menachem E, Edrich P, Van Vlyemen B, Sander JWAS, Schmidt B. Evidence for sustained efficacy of levetiracetam as add-on epilepsy therapy. Epilepsy Res 2003;53:57-64 - Ben-Menachem E. Preliminary efficacy of levetiracetam in monoterapy. Epileptic Disorder 2003;5(Suppl 1):S51-S55 - Betts T, Yarrow H, Greenhill L, Barrett M. Clinical experience of marketed levetiracetam in an epilepsy clinic - a one year follow-up study. Seizure 2003;12:140
Chang RS, Leung WC, Vassallo M, Sykes L, Battersby Wood E, Kwan J. Antiepileptic drugs for the primary and secondary prevention of seizures after stroke. Cochrane Database Syst Rev. 2022 Feb 7;2(2):CD005398. doi: 10.1002/14651858.CD005398.pub4.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 30, 2008
Record last verified: 2008-05
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