Epileptic SeizuresPhase 3EpIcNCT00542802
Levetiracetam Versus Carbamazepine in Post-Stroke Late Onset Crisis
A Phase 3 study testing Levetiracetam and Carbamazepine in people with Epileptic Seizures and Stroke, run by Scienze Neurologiche Ospedaliere at 24 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epileptic Seizures, Stroke
- What is being tested?
- Levetiracetam and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 24 sitesItaly
- Study dates
- Sep 2007to Jun 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
24 sites in 1 country.
Domenico Consoli, Doctor contact
24 sites in 1 country
Italy24 sites, 24 recruiting
- Not yet recruiting
Policlinico Umberto I
Ancona, 60020
LEANDRO PROVINCIALI
- Recruiting
Ospedale A. Perrino
Brindisi, 72100
BRUNO PASSARELLA
- Not yet recruiting
Ospedale Cannizzaro
Catania, 95126
ERMINIO COSTANZO
- Not yet recruiting
USL 2 Ospedale B.G. Villa
Città della Pieve, PG, 06062
STEFANO RICCI
- Not yet recruiting
Ospedale S. Croce E Carle
Cuneo, CN, 12100
ENZO GRASSO
- Recruiting
Ospedale Civile San Giovanni Battista di Foligno
Foligno, PG
Pierluigi BRUSTENGHI
- Recruiting
Ospedale S. Martino
Genova, GE, 16132
GIOVANNI REGESTA
- Recruiting
Ospedale San Martino
Genova
carlo GANDOLFO
- Recruiting
Ospedale Civile Imperia ASL 1
Imperia, 18100
Carlo SERRATI
- Recruiting
Ospedale A. Cardarelli-
Naples, 80131
MAURO PAGLIUCA, Dr.
- Not yet recruiting
Ospedale Cardarelli
Naples, 80131
VINCENZO ROSSI
- Not yet recruiting
Ospedale S. Giacomo
Novi Ligure, AL, 15057
MARCO AGUGGIA
- Not yet recruiting
Ospedale Civico
Palermo, 90100
ERALDO NATALE'
- Not yet recruiting
Istituto Neurologico C. Mondino
Pavia, PV, 27100
Anna Cavallini, doctor
Anna Cavallini, doctor
- Recruiting
Osp. Guglielmo da saliceto
Piacenza, 29100
DONATA GUIDETTI
- Recruiting
Ospedale Di Portogruaro
Portogruaro, VE, 30026
SEBASTIANO D'ANNA
- Recruiting
Arcispedale S. Maria Nuova
Reggio Emilia, 42100
Romana RIZZI
- Recruiting
Istituto Clinico Humanitas
Rozzano, MI, 20089
GIUSEPPE MICIELI
- Not yet recruiting
Ospedale Santa Maria della Misericordia
Sant'Andrea Delle Fratte, PG, 06131
ANNA CANTISANI
- Recruiting
Ospedale SS. Annunziata - Ospedale Civile
Taranto
saverio INTERNO'
- Recruiting
Ospedale Molinette-Università di Torino
Torino
Dario GIOBBE
- Recruiting
Azienda Ospedaliera Universitaria Trieste
Trieste, 34149
FABIO CHIODO GRANDI
- Recruiting
Ospedale Civile
Vibo Valentia, VV, 89900
domenico consoli, doctor
- Recruiting
Ospedale Guzzardi
Vittoria, RG, 97019
FRANCESCO IEMOLO
About this study
Official title: Multicenter, Comparative, Randomized, Open Trial to Evaluate Efficacy and Safety of Levetiracetam Versus Carbamazepine in Post Stroke Late Onset Crisis
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.
Read the 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.
- Conditions
- Epileptic Seizures, Stroke
- Being tested
- Levetiracetam, Carbamazepine
- Keywords
- post stroke epileptic late onset seizures
- Medical subject headings
- Seizures, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
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
CarbamazepineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| LEV | Experimental | Levetiracetam Receives: Drug: Levetiracetam |
| CAR | Active comparator | Carbamazepina Receives: Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients free from post stroke recurrent crisis
Measured: one year
Secondary outcomes (6)
To compare retention time of LEV vs CBZ since first intake throughout treatment period
Measured: one year
To compare time to second seizure in both treatments.
Measured: 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
Measured: one year
evaluate EEG changes as compared with baseline with that obtained at the end of treatment period
Measured: one year
To compare seizure frequency in levetiracetam and carbamazepine groups throughout treatment period
Measured: one year
To evaluate the safety of levetiracetam versus carbamazepine throughout the treatment period
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Epileptic SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scienze Neurologiche Ospedaliere
- Sponsor type
- University, hospital or other
- Investigators
- domenico consoli, doctor, Principal investigator, Ospedale Civile Vibo Valentia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542802
- Sponsor's protocol ID
- EpIc 1151
- Acronym
- EpIc
- Status last verified
- May 2008
- First submitted
- 11 Oct 2007
- Last updated
- 30 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Silverman IE, Restrepo L, Mathews GC. Poststroke seizures. Arch Neurol. 2002 Feb;59(2):195-201. doi: 10.1001/archneur.59.2.195.
PubMed 11843689Stephen LJ, Brodie MJ. Epilepsy in elderly people. Lancet. 2000 Apr 22;355(9213):1441-6. doi: 10.1016/S0140-6736(00)02149-8.
PubMed 10791538Inzitari 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.
PubMed 10938196Hauser 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.
PubMed 8504780Bladin 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.
PubMed 11074794Rhoney 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.
PubMed 10908901Olafsson 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.
PubMed 10999560Berger 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.
PubMed 3412583Sung CY, Chu NS. Epileptic seizures in thrombotic stroke. J Neurol. 1990 Jun;237(3):166-70. doi: 10.1007/BF00314589.
PubMed 2370564- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Comparative, Randomized, Open Trial to Evaluate Efficacy and Safety of Levetiracetam Versus Carbamazepine in Post Stroke Late Onset Crisis
- ClinicalTrials.gov ID
- NCT00542802
- Acronym / sponsor ID
- EpIc / EpIc 1151
- Conditions
- Epileptic Seizures, Stroke
- Keywords
- post stroke epileptic late onset seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Scienze Neurologiche OspedaliereUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 12 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEV | Experimental | Drug: LevetiracetamLevetiracetam |
| CAR | Active comparator | Drug: CarbamazepineCarbamazepina |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevetiracetamLevetiracetam 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 | Drug | LEV |
| CarbamazepineCarbamazepina 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 | Drug | CAR |
Primary outcome
number of patients free from post stroke recurrent crisis
Time frame: one year
6 secondary outcomes
To compare retention time of LEV vs CBZ since first intake throughout treatment period
Time frame: one year
To compare time to second seizure in both treatments.
Time frame: 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
Time frame: one year
evaluate EEG changes as compared with baseline with that obtained at the end of treatment period
Time frame: one year
To compare seizure frequency in levetiracetam and carbamazepine groups throughout treatment period
Time frame: one year
To evaluate the safety of levetiracetam versus carbamazepine throughout the treatment period
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2008.
- Background: PubMed 11843689Silverman IE, Restrepo L, Mathews GC. Poststroke seizures. Arch Neurol. 2002 Feb;59(2):195-201. doi: 10.1001/archneur.59.2.195.
- Background: PubMed 10791538Stephen LJ, Brodie MJ. Epilepsy in elderly people. Lancet. 2000 Apr 22;355(9213):1441-6. doi: 10.1016/S0140-6736(00)02149-8.
- Background: PubMed 10938196Inzitari 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.
- Background: PubMed 8504780Hauser 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.
- Background: PubMed 11074794Bladin 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.
- Background: PubMed 10908901Rhoney 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.
- Background: PubMed 10999560Olafsson 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.
- Background: PubMed 3412583Berger 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.
- Background: PubMed 2370564Sung CY, Chu NS. Epileptic seizures in thrombotic stroke. J Neurol. 1990 Jun;237(3):166-70. doi: 10.1007/BF00314589.
- Background- 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
- Background- 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
- Background- 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Domenico Consoli, Doctor contact
domenico consoli, doctor principal investigator
Ospedale Civile Vibo Valentia
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam and Carbamazepine in people with Epileptic Seizures and Stroke, run by Scienze Neurologiche Ospedaliere at 24 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Domenico Consoli, Doctor (domco@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients free from post stroke recurrent crisis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00542802, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2008.