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
Information provided by:
Scienze Neurologiche Ospedaliere
ClinicalTrials.gov Identifier:
First received: October 11, 2007
Last updated: May 26, 2008
Last verified: May 2008
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
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
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
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.


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

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

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

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
Principal Investigator: domenico consoli, doctor Ospedale Civile Vibo Valentia
  More Information

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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:
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Analgesics, Non-Narcotic
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Neuroprotective Agents
Nootropic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2015