Clinical trial NCT00175903: Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
Official title: A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Newly Diagnosed Epilepsy
Levetiracetam
Keppra
Carbamazepine
Valproate
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 1701
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of epilepsy (all types of seizures) was made during the past year
* 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:

* Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial
* 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

Primary outcomes:
measure: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety
timeFrame: Visit 1 to End of Study (approximately 52 weeks)
Secondary outcomes:
measure: 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
timeFrame: Visit 1 to End of Study (approximately 52 weeks)
measure: The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs
timeFrame: Visit 1 to Visit 4 (approximately 26 weeks)
measure: The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs
timeFrame: Visit 1 to Visit 5 (approximately 52 weeks)
measure: 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
timeFrame: Visit 1 to Visit 4 (approximately 26 weeks)
measure: 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
timeFrame: Visit 1 to Visit 5 (approximately 52 weeks)
measure: Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs
timeFrame: Visit 1 to Visit 4 (approximately 26 weeks)
measure: Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs
timeFrame: Visit 1 to Visit 5 (approximately 52 weeks)
measure: 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
timeFrame: Visit 1 to Visit 4 (approximately 26 weeks)
measure: 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
timeFrame: Visit 1 to Visit 5 (approximately 52 weeks)
measure: Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs
timeFrame: Visit 1 to End of Study (approximately 52 weeks)
measure: 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
timeFrame: Visit 1 to End of Study (approximately 52 weeks)
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Bedford Park
country: Australia
city: Brisbane
country: Australia
city: Cairns
country: Australia
city: Camperdown
country: Australia
city: Chatswood
country: Australia
city: Clayton
country: Australia
city: Maroochydore
country: Australia
city: Parkville
country: Australia
city: Perth
country: Australia
city: Randwick
country: Australia
city: West Heidelberg
country: Australia
city: Graz
country: Austria
city: Innsbrick
country: Austria
city: Klagenfurt
country: Austria
city: Linz
country: Austria
city: Steyr
country: Austria
city: Vienna
country: Austria
city: Brugge
country: Belgium
city: Dendermonde
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Haine St Paul
country: Belgium
city: Jette
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Oostende
country: Belgium
city: Ottignies
country: Belgium
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Litomysl
country: Czech Republic
city: Ostrava-Poruba
country: Czech Republic
city: Zlin
country: Czech Republic
city: Aalborg
country: Denmark
city: Copenhagen
country: Denmark
city: Holbaek
country: Denmark
city: Holstebro
country: Denmark
city: Hus (Helsinki)
country: Finland
city: Kuopio
country: Finland
city: Tampere
country: Finland
city: Blaye
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Carcassonne
country: France
city: Cherbourg
country: France
city: Colmar
country: France
city: Creil
country: France
city: Dijon
country: France
city: Freyming Merlebach
country: France
city: Grenoble Cedex 9
country: France
city: La Seyne Sur Mer
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Mulhouse
country: France
city: Nancy
country: France
city: Nimes
country: France
city: Paris
country: France
city: Rennes
country: France
city: Roanne
country: France
city: Saint Brieuc
country: France
city: Saint Quentin
country: France
city: Toulouse Cedex 04
country: France
city: Valenciennes
country: France
city: Vesoul
country: France
city: Altenburg
country: Germany
city: Arnsdorf
country: Germany
city: Aschaffenburg
country: Germany
city: Bamberg
country: Germany
city: Berlin - Hohenschonhausen
country: Germany
city: Berlin
country: Germany
city: Bernau
country: Germany
city: Bernburg
country: Germany
city: Bielefeld
country: Germany
city: Bonn
country: Germany
city: Butzbach
country: Germany
city: Celle
country: Germany
city: Dillingen
country: Germany
city: Dresden
country: Germany
city: Dusseldorf
country: Germany
city: Erbach
country: Germany
city: Essen
country: Germany
city: Giessen
country: Germany
city: Gottingen
country: Germany
city: Halle/Saale
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Jena
country: Germany
city: Konigsbruck
country: Germany
city: Leipzig
country: Germany
city: Lengerich
country: Germany
city: Liegau-Augustusbad
country: Germany
city: Mittweida
country: Germany
city: Munster
country: Germany
city: Neukirchen-Vluyn
country: Germany
city: Neumunster
country: Germany
city: Oldenburg
country: Germany
city: Potsdam
country: Germany
city: Quickborn
country: Germany
city: Regenburg
country: Germany
city: Schalmstadt-Treysa
country: Germany
city: Siegen
country: Germany
city: Wermsdorf
country: Germany
city: Aklion
country: Greece
city: Alexandroupolis
country: Greece
city: Athens
country: Greece
city: Patras
country: Greece
city: Thessalonikis
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Dublin 9
country: Ireland
city: Dublin
country: Ireland
city: Ancona
country: Italy
city: Asti
country: Italy
city: Bari
country: Italy
city: Busto Arsizio
country: Italy
city: Casarano
country: Italy
city: Catania
country: Italy
city: Cremona
country: Italy
city: Eboli
country: Italy
city: Faenza
country: Italy
city: Ferrara
country: Italy
city: Firenze
country: Italy
city: Foggia
country: Italy
city: Forli
country: Italy
city: Garbagnate
country: Italy
city: Grosseto
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Perugia
country: Italy
city: Pescara
country: Italy
city: Pisa
country: Italy
city: Potenza
country: Italy
city: Prato
country: Italy
city: Ragusa
country: Italy
city: Reggio Emilia
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Taranto
country: Italy
city: Torino
country: Italy
city: Udine
country: Italy
city: Verona
country: Italy
city: Vimercate
country: Italy
city: Vittoria
country: Italy
city: Eindhoven
country: Netherlands
city: Heerenvegen
country: Netherlands
city: Leeuwarden
country: Netherlands
city: Maastricht
country: Netherlands
city: Nijmegen
country: Netherlands
city: Tilburg
country: Netherlands
city: Drammen
country: Norway
city: Fredrikstad
country: Norway
city: Lillehammer
country: Norway
city: Molde
country: Norway
city: Nordbyhagen
country: Norway
city: Sandvika
country: Norway
city: Stavanger
country: Norway
city: Tonsberg
country: Norway
city: Tromso
country: Norway
city: Trondheim
country: Norway
city: Bydgoszcz
country: Poland
city: Czestochowa
country: Poland
city: Gdansk
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Olstyn
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Zgierz
country: Poland
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
city: Krasnoyasrk
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Bratislava
country: Slovakia
city: Dolni Kubin
country: Slovakia
city: Dubnica Nad Vahom
country: Slovakia
city: Martin
country: Slovakia
city: Zilina
country: Slovakia
city: Badalona
country: Spain
city: Barakaldo Vizcaya
country: Spain
city: Barcelona
country: Spain
city: Castellon
country: Spain
city: Elda
country: Spain
city: Girona
country: Spain
city: Leganes (Madrid)
country: Spain
city: Madrid
country: Spain
city: Mostoles
country: Spain
city: Murcia
country: Spain
city: Santa Cruz De Tenerife
country: Spain
city: Sevilla
country: Spain
city: Terrassa
country: Spain
city: Valencia
country: Spain
city: Vigo
country: Spain
city: Karlstad
country: Sweden
city: Linkoping
country: Sweden
city: Motala
country: Sweden
city: Stockholm
country: Sweden
city: Varberg
country: Sweden
city: Bern
country: Switzerland
city: Biel
country: Switzerland
city: Geneve
country: Switzerland
city: Lausanne
country: Switzerland
city: St. Gallen
country: Switzerland
city: Zurich
country: Switzerland
city: Adana
country: Turkey
city: Ankara
country: Turkey
city: Bursa
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Ashford
country: United Kingdom
city: Bangor
country: United Kingdom
city: Bristol
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Dundee
country: United Kingdom
city: Leeds
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Southampton
country: United Kingdom
city: Stoke on Trent
country: United Kingdom
city: Sunderland
country: United Kingdom
city: Swindon
country: United Kingdom
city: Truro
country: United Kingdom
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.