Levetiracetam Versus Carbamazepine in Post-Stroke Late Onset Crisis (EpIc)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Scienze Neurologiche Ospedaliere.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Scienze Neurologiche Ospedaliere
ClinicalTrials.gov Identifier:
NCT00542802
First received: October 11, 2007
Last updated: May 26, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Epileptic Seizures
Stroke
Drug: Levetiracetam
Drug: Carbamazepine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Comparative, Randomized, Open Trial to Evaluate Efficacy and Safety of Levetiracetam Versus Carbamazepine in Post Stroke Late Onset Crisis

Resource links provided by NLM:


Further study details as provided by Scienze Neurologiche Ospedaliere:

Primary Outcome Measures:
  • number of patients free from post stroke recurrent crisis [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare retention time of LEV vs CBZ since first intake throughout treatment period [ Time Frame: one year ] [ Designated as safety issue: No ]
  • To compare time to second seizure in both treatments. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: one year ] [ Designated as safety issue: No ]
  • evaluate EEG changes as compared with baseline with that obtained at the end of treatment period [ Time Frame: one year ] [ Designated as safety issue: No ]
  • To compare seizure frequency in levetiracetam and carbamazepine groups throughout treatment period [ Time Frame: one year ] [ Designated as safety issue: No ]
  • To evaluate the safety of levetiracetam versus carbamazepine throughout the treatment period [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 630
Study Start Date: September 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LEV
Levetiracetam
Drug: Levetiracetam
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
Active Comparator: CAR
Carbamazepina
Drug: Carbamazepine
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

Detailed Description:

Stroke is the most common cause of seizures in the elderly and seizures are among the most common sequelae of stroke.

About 10% of patients experience seizures since stroke onset up to several years (Silverman 2002). Arbitrarly a cut point of 2 weeks divide early seizures from late seizures (Honey 2000, Olofson 2000, Berger 1989).Late occurrence of late seizure appears to carry a high risk for epilepsy (Wilmore 1990).

The risk of epilepsy in some patients with a single stroke-related seizure is high enough to justify starting an anticonvulsant therapy before a second seizure occurs(Labovitz 2003).

Levetiracetam (S-α-ethil-2-oxo-pyrrolidine acetamide) is S-enantiomer of a pyrrolidine derivative and is unrelated to any other AED and has a unique preclinical and clinical profile (Gower et al 1992).

Levetiracetam (LEV) binds with a stereospecific binding site in the CNS that is saturable and reversible (Noyer 1995). This site actually known as LBS Levetiracetam Binding Site) is unique and do not correspond to any known receptor or channel that might be involved in neuroexcitability (Gillard 2003).

LEV selectively inhibits N-type Ca2 channels of CA1 pyramidal hyppocampal neurons (Lukyanetz et a 2002) and, despite of not having any activity on GABA-gated currents, it shows a potent ability to reverse the inhibitory effects of the negative allosteric modulators zinc and β-carbolines on both GABAA and glycine receptor mediated responses(Rigo et al. 2002).

LEV has no effects on normal neurons (Birnstiel et al.1997) LEV as other AEDs has effect in decreasing repetitive neuronal firing, but only LEV reduces the number of cells firing synchronously (amplitude) of the evoked PS(Margineau and Klitgaard 2000).

The efficacy profile of the drug has been established through three pivotal randomized double blind, placebo controlled, parallel studies on 904 patients suffering from partial seizures secondarily or not generalised that were not well controlled by previous treatment (Shorvon et al. 2000; Ben-Menachem et al. 2000; Cereghino et al. 2000).In these three studies LEV showed a significant reduction of seizure frequency. A pooled analysis of the results from these three studies supports a dose-response effect for levetiracetam: responder rates were 28.5, 34.3 and 41.3 % for patients treated with levetiracetam 1000, 2000, 3000 mg/day respectively, as compared with 13.1% for placebo group. The respective values for complete seizure freedom were 4.7, 6.3, 8.6 and 0.8%(Privitera 2002, Boon et al, 2002).

In a review of data for 1422 patients treated with levetiracetam, 38.6% of patients experienced a ≥ 50% reduction in seizure frequency and 20% experienced a reduction of ≥ 75%. The present study is not blinded because one of the purposes with the study has been to mimic daily clinical practice as close as possible.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients having a stroke (ischemic and haemorrhagic) showing (one) subsequent seizure 14 days up to 3 years after stroke
  • Patients has signed the informed consent form
  • Aged ≥ 18 years

Exclusion Criteria:

  • Severe stroke patients with Rankin scale > 3
  • Patients with a life expectancy of < 12 months
  • Patients screened more than 15 days after first seizure
  • Patients with a diagnosed epilepsy
  • Patients with clear evidence of myoclonic seizures
  • Patients with contraindication to levetiracetam and carbamazepine use
  • Patients presenting epileptic status at onset
  • Patients having a MMSE <24
  • Patients having a seizure before stroke
  • Patients taking any AED 4 weeks prior to randomisation in the study
  • Patients showing dysphagia after stroke not able to swallow tablets.
  • Patients with a low compliance for the study
  • Pregnant women, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method.
  • Allergy or intolerance to pyrrolidine derivatives and/or tablet excipients or to carbamazepine derivates and /or tablet excipients
  • Patients involved in another clinical trial 30 days prior randomization
  • Patients with any tumour
  • Patients with previous traumatic brain accident resulting in impairment of consciousness.
  • Patients for whom it is not possible to assess seizure onset
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542802

Contacts
Contact: Domenico Consoli, Doctor domco@tiscali.it
Contact: Sara Papetti 0382 530676 ext +39 spapetti@gbpharmaservices.it

Locations
Italy
Ospedale S. Giacomo Not yet recruiting
Novi Ligure, AL, Italy, 15057
Principal Investigator: MARCO AGUGGIA         
Ospedale S. Croce E Carle Not yet recruiting
Cuneo, CN, Italy, 12100
Principal Investigator: ENZO GRASSO         
Ospedale S. Martino Recruiting
Genova, GE, Italy, 16132
Principal Investigator: GIOVANNI REGESTA         
Istituto Clinico Humanitas Recruiting
Rozzano, MI, Italy, 20089
Principal Investigator: GIUSEPPE MICIELI         
USL 2 Ospedale B.G. Villa Not yet recruiting
Città della Pieve, PG, Italy, 06062
Principal Investigator: STEFANO RICCI         
Ospedale Civile San Giovanni Battista di Foligno Recruiting
Foligno, PG, Italy
Principal Investigator: Pierluigi BRUSTENGHI         
Ospedale Santa Maria della Misericordia Not yet recruiting
Sant'Andrea delle Fratte, PG, Italy, 06131
Principal Investigator: ANNA CANTISANI         
Istituto Neurologico C. Mondino Not yet recruiting
Pavia, PV, Italy, 27100
Contact: Anna Cavallini, doctor         
Principal Investigator: Anna Cavallini, doctor         
Ospedale Guzzardi Recruiting
Vittoria, RG, Italy, 97019
Principal Investigator: FRANCESCO IEMOLO         
Ospedale Di Portogruaro Recruiting
Portogruaro, VE, Italy, 30026
Principal Investigator: SEBASTIANO D'ANNA         
Ospedale Civile Recruiting
Vibo Valentia, VV, Italy, 89900
Principal Investigator: domenico consoli, doctor         
Policlinico Umberto I Not yet recruiting
Ancona, Italy, 60020
Principal Investigator: LEANDRO PROVINCIALI         
Ospedale A. Perrino Recruiting
Brindisi, Italy, 72100
Principal Investigator: BRUNO PASSARELLA         
Ospedale Cannizzaro Not yet recruiting
Catania, Italy, 95126
Principal Investigator: ERMINIO COSTANZO         
Ospedale San Martino Recruiting
Genova, Italy
Principal Investigator: carlo GANDOLFO         
Ospedale Civile Imperia ASL 1 Recruiting
Imperia, Italy, 18100
Principal Investigator: Carlo SERRATI         
Ospedale Cardarelli Not yet recruiting
Napoli, Italy, 80131
Principal Investigator: VINCENZO ROSSI         
Ospedale A. Cardarelli- Recruiting
Napoli, Italy, 80131
Principal Investigator: MAURO PAGLIUCA, Dr.         
Ospedale Civico Not yet recruiting
Palermo, Italy, 90100
Principal Investigator: ERALDO NATALE'         
Osp. Guglielmo da saliceto Recruiting
Piacenza, Italy, 29100
Principal Investigator: DONATA GUIDETTI         
Arcispedale S. Maria Nuova Recruiting
Reggio Emilia, Italy, 42100
Principal Investigator: Romana RIZZI         
Ospedale SS. Annunziata - Ospedale Civile Recruiting
Taranto, Italy
Principal Investigator: saverio INTERNO'         
Ospedale Molinette-Università di Torino Recruiting
Torino, Italy
Principal Investigator: Dario GIOBBE         
Azienda Ospedaliera Universitaria Trieste Recruiting
Trieste, Italy, 34149
Principal Investigator: FABIO CHIODO GRANDI         
Sponsors and Collaborators
Scienze Neurologiche Ospedaliere
Investigators
Principal Investigator: domenico consoli, doctor Ospedale Civile Vibo Valentia
  More Information

Publications:
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- 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
- Burn J. Epileptic seizure after a first stroke - BMJ 1997; 315: 115-118 - Abou-Khalil B, Lanzeby B. Long-term experience with Levetiracetam. Epileptic Disord 2003;5S1:S33-S37 - Alsaadi TM, Koopmans S, Apperson M, Farias S. Levetiracetam monotherapy for elderly patients with epilepsy. Seizure 2004;13:58-60 - Angehagen M, Margineau DG, Ben-Menachem E, Ronnback L, Hansson E, Klitgaard H Levetiracetam reduces caffeine-induced Ca2+ transients and epileptiform potentials in hippocampal neurons Neuroreport 2003; vol14(3): 471-475
- 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

Responsible Party: Dr. Domenico Consoli, Scienze Neurologiche Ospedaliere
ClinicalTrials.gov Identifier: NCT00542802     History of Changes
Other Study ID Numbers: EpIc 1151
Study First Received: October 11, 2007
Last Updated: May 26, 2008
Health Authority: Italy: Ethics Committee
Italy: The Italian Medicines Agency

Keywords provided by Scienze Neurologiche Ospedaliere:
post stroke epileptic late onset seizures

Additional relevant MeSH terms:
Epilepsy
Seizures
Stroke
Cerebral Infarction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Carbamazepine
Etiracetam
Piracetam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 29, 2014