Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
NCT ID: NCT00175903
Last Updated: 2015-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1701 participants
INTERVENTIONAL
2005-02-28
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Levetiracetam
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Levetiracetam
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Older Antepileptic Drugs
Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.
Carbamazepine Controlled Release (CBZ-CR)
Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
Valproate Extended Release
Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
Interventions
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Levetiracetam
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Carbamazepine Controlled Release (CBZ-CR)
Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
Valproate Extended Release
Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
Eligibility Criteria
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Inclusion Criteria
* Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months
* Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
Exclusion Criteria
* Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial
* Pregnant or lactating women
* Presence of known pseudoseizures within the last year
* Uncountable seizures (clusters) or history of convulsive status epilepticus
* Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs
* History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years
* Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors
* Presence of a terminal illness or any medical condition that might interfere with the subject's trial participation
16 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
UCB Pharma
Locations
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Adelaide, , Australia
Bedford Park, , Australia
Brisbane, , Australia
Cairns, , Australia
Camperdown, , Australia
Chatswood, , Australia
Clayton, , Australia
Maroochydore, , Australia
Parkville, , Australia
Perth, , Australia
Randwick, , Australia
West Heidelberg, , Australia
Graz, , Austria
Innsbrick, , Austria
Klagenfurt, , Austria
Linz, , Austria
Steyr, , Austria
Vienna, , Austria
Bruges, , Belgium
Dendermonde, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Haine-Saint-Paul, , Belgium
Jette, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Ostend, , Belgium
Ottignies, , Belgium
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Litomyšl, , Czechia
Ostrava-Poruba, , Czechia
Zlín, , Czechia
Aalborg, , Denmark
Copenhagen, , Denmark
Holbæk, , Denmark
Holstebro, , Denmark
Hus (Helsinki), , Finland
Kuopio, , Finland
Tampere, , Finland
Blaye, , France
Bordeaux, , France
Brest, , France
Carcassonne, , France
Cherbourg, , France
Colmar, , France
Creil, , France
Dijon, , France
Freyming-Merlebach, , France
Grenoble, , France
La Seyne-sur-Mer, , France
Lille, , France
Lyon, , France
Marseille, , France
Mulhouse, , France
Nancy, , France
Nîmes, , France
Paris, , France
Rennes, , France
Roanne, , France
Saint-Brieuc, , France
Saint-Quentin, , France
Toulouse, , France
Valenciennes, , France
Vesoul, , France
Altenburg, , Germany
Arnsdorf, , Germany
Aschaffenburg, , Germany
Bamberg, , Germany
Berlin, , Germany
Bernau, , Germany
Bernburg, , Germany
Bielefeld, , Germany
Bonn, , Germany
Butzbach, , Germany
Celle, , Germany
Dillingen, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Erbach im Odenwald, , Germany
Essen, , Germany
Giessen, , Germany
Göttingen, , Germany
Halle, , Germany
Hamburg, , Germany
Hohenschönhausen, , Germany
Jena, , Germany
Königsbrück, , Germany
Leipzig, , Germany
Lengerich, , Germany
Liegau-Augustusbad, , Germany
Mittweida, , Germany
Münster, , Germany
Neukirchen-Vluyn, , Germany
Neumünster, , Germany
Oldenburg, , Germany
Potsdam, , Germany
Quickborn, , Germany
Regenburg, , Germany
Schalmstadt-Treysa, , Germany
Siegen, , Germany
Wermsdorf, , Germany
Aklion, , Greece
Alexandroupoli, , Greece
Athens, , Greece
Pátrai, , Greece
Thessaloniki, , Greece
Thessalonikis, , Greece
Budapest, , Hungary
Debrecen, , Hungary
Pécs, , Hungary
Dublin, , Ireland
Ancona, , Italy
Asti, , Italy
Bari, , Italy
Busto Arsizio, , Italy
Casarano, , Italy
Catania, , Italy
Cremona, , Italy
Eboli, , Italy
Faenza, , Italy
Ferrara, , Italy
Florence, , Italy
Foggia, , Italy
Forlì, , Italy
Garbagnate, , Italy
Grosseto, , Italy
Milan, , Italy
Napoli, , Italy
Padua, , Italy
Perugia, , Italy
Pescara, , Italy
Pisa, , Italy
Potenza, , Italy
Prato, , Italy
Ragusa, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Siena, , Italy
Taranto, , Italy
Torino, , Italy
Udine, , Italy
Verona, , Italy
Vimercate, , Italy
Vittoria, , Italy
Eindhoven, , Netherlands
Heerenvegen, , Netherlands
Leeuwarden, , Netherlands
Maastricht, , Netherlands
Nijmegen, , Netherlands
Tilburg, , Netherlands
Drammen, , Norway
Fredrikstad, , Norway
Lillehammer, , Norway
Molde, , Norway
Nordbyhagen, , Norway
Sandvika, , Norway
Stavanger, , Norway
Tromsø, , Norway
Trondheim, , Norway
Tønsberg, , Norway
Bydgoszcz, , Poland
Częstochowa, , Poland
Gdansk, , Poland
Kielce, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Olsztyn, , Poland
Poznan, , Poland
Warsaw, , Poland
Zgierz, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Krasnoyasrk, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Bratislava, , Slovakia
Dolný Kubín, , Slovakia
Dubnica nad Váhom, , Slovakia
Martin, , Slovakia
Žilina, , Slovakia
Badalona, , Spain
Barakaldo Vizcaya, , Spain
Barcelona, , Spain
Castellon, , Spain
Elda, , Spain
Girona, , Spain
Leganes (Madrid), , Spain
Madrid, , Spain
Móstoles, , Spain
Murcia, , Spain
Santa Cruz de Tenerife, , Spain
Seville, , Spain
Terrassa, , Spain
Valencia, , Spain
Vigo, , Spain
Karlstad, , Sweden
Linköping, , Sweden
Motala, , Sweden
Stockholm, , Sweden
Varberg, , Sweden
Bern, , Switzerland
Biel, , Switzerland
Geneva, , Switzerland
Lausanne, , Switzerland
Sankt Gallen, , Switzerland
Zurich, , Switzerland
Adana, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Bursa, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Ashford, , United Kingdom
Bangor, , United Kingdom
Bristol, , United Kingdom
Cardiff, , United Kingdom
Dundee, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Plymouth, , United Kingdom
Southampton, , United Kingdom
Stoke-on-Trent, , United Kingdom
Sunderland, , United Kingdom
Swindon, , United Kingdom
Truro, , United Kingdom
Countries
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References
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Pohlmann-Eden B, Marson AG, Noack-Rink M, Ramirez F, Tofighy A, Werhahn KJ, Wild I, Trinka E. Comparative effectiveness of levetiracetam, valproate and carbamazepine among elderly patients with newly diagnosed epilepsy: subgroup analysis of the randomized, unblinded KOMET study. BMC Neurol. 2016 Aug 23;16(1):149. doi: 10.1186/s12883-016-0663-7.
Trinka E, Marson AG, Van Paesschen W, Kalviainen R, Marovac J, Duncan B, Buyle S, Hallstrom Y, Hon P, Muscas GC, Newton M, Meencke HJ, Smith PE, Pohlmann-Eden B; KOMET Study Group. KOMET: an unblinded, randomised, two parallel-group, stratified trial comparing the effectiveness of levetiracetam with controlled-release carbamazepine and extended-release sodium valproate as monotherapy in patients with newly diagnosed epilepsy. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1138-47. doi: 10.1136/jnnp-2011-300376. Epub 2012 Aug 29.
Other Identifiers
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2004-001339-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01175
Identifier Type: -
Identifier Source: org_study_id
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