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
Recruitment status was Recruiting
Sponsor:
Scienze Neurologiche Ospedaliere
Information provided by:
Scienze Neurologiche Ospedaliere
ClinicalTrials.gov Identifier:
NCT00542802
First received: October 11, 2007
Last updated: May 26, 2008
Last verified: May 2008
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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:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
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
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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
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
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- 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
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- 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 May 23, 2013