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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001339-41 | EudraCT Number |
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Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily. |
|
| Older Antepileptic Drugs | Active Comparator | Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety | Visit 1 to End of Study (approximately 52 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| The time to withdrawal comparing Levetiracetam versus the older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release | Visit 1 to End of Study (approximately 52 weeks) | |
| The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | Australia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27552848 | Derived | 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. | |
| 22933814 |
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| Carbamazepine Controlled Release (CBZ-CR) | Drug | Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily. |
|
| Valproate Extended Release | Drug | Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily. |
|
| Visit 1 to Visit 4 (approximately 26 weeks) |
| The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs | Visit 1 to Visit 5 (approximately 52 weeks) |
| The retention rate after 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release | Visit 1 to Visit 4 (approximately 26 weeks) |
| The retention rate after 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release | Visit 1 to Visit 5 (approximately 52 weeks) |
| Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs | Visit 1 to Visit 4 (approximately 26 weeks) |
| Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs | Visit 1 to Visit 5 (approximately 52 weeks) |
| Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release | Visit 1 to Visit 4 (approximately 26 weeks) |
| Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release | Visit 1 to Visit 5 (approximately 52 weeks) |
| Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs | Visit 1 to End of Study (approximately 52 weeks) |
| Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release | Visit 1 to End of Study (approximately 52 weeks) |
| 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 |
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| Klagenfurt | Austria |
| Linz | Austria |
| Steyr | Austria |
| Vienna | Austria |
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| Edegem | Belgium |
| Ghent | Belgium |
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| Ostrava-Poruba | Czechia |
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| 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 |
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| Lyon | France |
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| Nancy | France |
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| Rennes | France |
| Roanne | France |
| Saint-Brieuc | France |
| Saint-Quentin | France |
| Toulouse | France |
| Valenciennes | France |
| Vesoul | France |
| Altenburg | Germany |
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| Aschaffenburg | Germany |
| Bamberg | Germany |
| Berlin | Germany |
| Bernau | Germany |
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| Butzbach | Germany |
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| Düsseldorf | Germany |
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| Göttingen | Germany |
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| Hamburg | Germany |
| Hohenschönhausen | Germany |
| Jena | Germany |
| Königsbrück | Germany |
| Leipzig | Germany |
| Lengerich | Germany |
| Liegau-Augustusbad | Germany |
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| 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 |
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| Thessaloniki | Greece |
| Thessalonikis | Greece |
| Budapest | Hungary |
| Debrecen | Hungary |
| Pécs | Hungary |
| Dublin | Ireland |
| Ancona | Italy |
| Asti | Italy |
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| Busto Arsizio | Italy |
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| Torino | Italy |
| Udine | Italy |
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| 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 |
| 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. |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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