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Sponsored by: |
Scienze Neurologiche Ospedaliere |
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Information provided by: | Scienze Neurologiche Ospedaliere |
ClinicalTrials.gov Identifier: | NCT00542802 |
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 |
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Epileptic Seizures Stroke |
Drug: Levetiracetam Drug: Carbamazepine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Multicenter, Comparative, Randomized, Open Trial to Evaluate Efficacy and Safety of Levetiracetam Versus Carbamazepine in Post Stroke Late Onset Crisis |
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 |
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LEV: Experimental
Levetiracetam
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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
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CAR: Active Comparator
Carbamazepina
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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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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Domenico Consoli, Doctor | domco@tiscali.it | |
Contact: Sara Papetti | 0382 530676 ext +39 | spapetti@gbpharmaservices.it |
Italy | |
Azienda Ospedaliera Universitaria Trieste | Recruiting |
TRIESTE, Italy, 34149 | |
Principal Investigator: FABIO CHIODO GRANDI | |
Policlinico Umberto I | Not yet recruiting |
ANCONA, Italy, 60020 | |
Principal Investigator: LEANDRO PROVINCIALI | |
Osp. Guglielmo da saliceto | Recruiting |
PIACENZA, Italy, 29100 | |
Principal Investigator: DONATA GUIDETTI | |
Ospedale A. Cardarelli- | Recruiting |
NAPOLI, Italy, 80131 | |
Principal Investigator: MAURO PAGLIUCA, Dr. | |
Ospedale A. Perrino | Recruiting |
BRINDISI, Italy, 72100 | |
Principal Investigator: BRUNO PASSARELLA | |
Ospedale Cannizzaro | Not yet recruiting |
CATANIA, Italy, 95126 | |
Principal Investigator: ERMINIO COSTANZO | |
Ospedale SS. Annunziata - Ospedale Civile | Recruiting |
Taranto, Italy | |
Principal Investigator: saverio INTERNO' | |
Ospedale Civico | Not yet recruiting |
PALERMO, Italy, 90100 | |
Principal Investigator: ERALDO NATALE' | |
Arcispedale S. Maria Nuova | Recruiting |
REGGIO EMILIA, Italy, 42100 | |
Principal Investigator: Romana RIZZI | |
Ospedale Civile Imperia ASL 1 | Recruiting |
IMPERIA, Italy, 18100 | |
Principal Investigator: Carlo SERRATI | |
Ospedale Molinette-Università di Torino | Recruiting |
TORINO, Italy | |
Principal Investigator: Dario GIOBBE | |
Ospedale Cardarelli | Not yet recruiting |
NAPOLI, Italy, 80131 | |
Principal Investigator: VINCENZO ROSSI | |
Ospedale San Martino | Recruiting |
GENOVA, Italy | |
Principal Investigator: carlo GANDOLFO | |
Italy, AL | |
Ospedale S. Giacomo | Not yet recruiting |
NOVI LIGURE, AL, Italy, 15057 | |
Principal Investigator: MARCO AGUGGIA | |
Italy, CN | |
Ospedale S. Croce E Carle | Not yet recruiting |
CUNEO, CN, Italy, 12100 | |
Principal Investigator: ENZO GRASSO | |
Italy, GE | |
Ospedale S. Martino | Recruiting |
GENOVA, GE, Italy, 16132 | |
Principal Investigator: GIOVANNI REGESTA | |
Italy, MI | |
Istituto Clinico Humanitas | Recruiting |
ROZZANO, MI, Italy, 20089 | |
Principal Investigator: GIUSEPPE MICIELI | |
Italy, PG | |
Ospedale Santa Maria della Misericordia | Not yet recruiting |
Sant'Andrea delle Fratte, PG, Italy, 06131 | |
Principal Investigator: ANNA CANTISANI | |
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 | |
Italy, PV | |
Istituto Neurologico C. Mondino | Not yet recruiting |
Pavia, PV, Italy, 27100 | |
Contact: Anna Cavallini, doctor | |
Principal Investigator: Anna Cavallini, doctor | |
Italy, RG | |
Ospedale Guzzardi | Recruiting |
VITTORIA, RG, Italy, 97019 | |
Principal Investigator: FRANCESCO IEMOLO | |
Italy, VE | |
Ospedale Di Portogruaro | Recruiting |
PORTOGRUARO, VE, Italy, 30026 | |
Principal Investigator: SEBASTIANO D'ANNA | |
Italy, VV | |
Ospedale Civile | Recruiting |
Vibo Valentia, VV, Italy, 89900 | |
Principal Investigator: domenico consoli, doctor |
Principal Investigator: | domenico consoli, doctor | Ospedale Civile Vibo Valentia |
Responsible Party: | Scienze Neurologiche Ospedaliere ( Dr. Domenico Consoli ) |
Study ID Numbers: | EpIc 1151 |
Study First Received: | October 11, 2007 |
Last Updated: | May 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00542802 |
Health Authority: | Italy: Ethics Committee; Italy: The Italian Medicines Agency |
post stroke epileptic late onset seizures |
Cerebral Infarction Seizures Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases Cerebrovascular Disorders |
Signs and Symptoms Carbamazepine Epilepsy Neurologic Manifestations Brain Ischemia Etiracetam Brain Infarction Infarction |
Nootropic Agents Tranquilizing Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antimanic Agents Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Cardiovascular Diseases Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |