Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: LEVETIRACETAM (UCB) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
SONJA BUYLE, MD, Study Director, Affiliation: UCB
Summary
Open label, multicenter, international, randomized, parallel group, phase IIIb study
comparing the efficacy and safety of levetiracetam to two standard antiepileptic drugs (CBZ
and VPA) in patients with newly diagnosed epilepsy in a clinical practice setting.
Clinical Details
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 design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: TIME TO WITHDRAWAL OF STUDY MEDICATION AS A COMBINED MEASURE OF EFFICACY AND SAFETY
Secondary outcome: EFFICACY:RETENTION RATE; SEIZURE FREEDOM AT 6 AND 12 MONTHS; TIME TO FIRST SEIZURE.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Cairns, Australia
Chatswood, Australia
Adelaide, Australia
Perth, Australia
Brisbane, Australia
Camperdown, Australia
West Heidelberg, Australia
Clayton, Australia
Maroochydore, Australia
Parkville, Australia
Randwick, Australia
Bedford Park, Australia
Linz, Austria
Klagenfurt, Austria
Vienna, Austria
Graz, Austria
Steyr, Austria
Innsbrick, Austria
Haine St Paul, Belgium
Oostende, Belgium
Edegem, Belgium
Ottignies, Belgium
Kortrijk, Belgium
Jette, Belgium
Dendermonde, Belgium
Gent, Belgium
Brugge, Belgium
Leuven, Belgium
Varna, Bulgaria
Sofia, Bulgaria
Plovdiv, Bulgaria
Ostrava-Poruba, Czech Republic
Litomysl, Czech Republic
Zlin, Czech Republic
Holstebro, Denmark
Aalborg, Denmark
Holbaek, Denmark
Copenhagen, Denmark
Kuopio, Finland
Hus (Helsinki), Finland
Tampere, Finland
Valenciennes, France
Mulhouse, France
Saint Quentin, France
Cherbourg, France
Lyon, France
Vesoul, France
Paris, France
Rennes, France
Creil, France
Brest, France
Dijon, France
Bordeaux, France
Freyming Merlebach, France
Lille, France
Saint Brieuc, France
Roanne, France
La Seyne Sur Mer, France
Grenoble Cedex 9, France
Nancy, France
Toulouse Cedex 04, France
Colmar, France
Nimes, France
Blaye, France
Carcassonne, France
Marseille, France
Neukirchen-Vluyn, Germany
Altenburg, Germany
Leipzig, Germany
Aschaffenburg, Germany
Hamburg, Germany
Potsdam, Germany
Berlin, Germany
Bonn, Germany
Dillingen, Germany
Bernburg, Germany
Munster, Germany
Berlin - Hohenschonhausen, Germany
Regenburg, Germany
Neumunster, Germany
Celle, Germany
Halle/Saale, Germany
Lengerich, Germany
Essen, Germany
Quickborn, Germany
Wermsdorf, Germany
Butzbach, Germany
Bamberg, Germany
Konigsbruck, Germany
Halle, Germany
Liegau-Augustusbad, Germany
Schalmstadt-Treysa, Germany
Oldenburg, Germany
Siegen, Germany
Bielefeld, Germany
Dusseldorf, Germany
Erbach, Germany
Arnsdorf, Germany
Dresden, Germany
Bernau, Germany
Gottingen, Germany
Mittweida, Germany
Giessen, Germany
Jena, Germany
Athens, Greece
Thessalonikis, Greece
Thessaloniki, Greece
Alexandroupolis, Greece
Aklion, Greece
Patras, Greece
Budapest, Hungary
Pecs, Hungary
Debrecen, Hungary
Dublin 9, Ireland
Dublin, Ireland
Grosseto, Italy
Torino, Italy
Udine, Italy
Cremona, Italy
Ragusa, Italy
Prato, Italy
Milano, Italy
Catania, Italy
Vimercate, Italy
Perugia, Italy
Napoli, Italy
Forli, Italy
Roma, Italy
Eboli, Italy
Pisa, Italy
Bari, Italy
Vittoria, Italy
Ferrara, Italy
Verona, Italy
Firenze, Italy
Pescara, Italy
Potenza, Italy
Faenza, Italy
Garbagnate, Italy
Busto Arsizio, Italy
Ancona, Italy
Reggio Emilia, Italy
Siena, Italy
Padova, Italy
Foggia, Italy
Casarano, Italy
Taranto, Italy
Asti, Italy
Tilburg, Netherlands
Maastricht, Netherlands
Leeuwarden, Netherlands
Nijmegen, Netherlands
Heerenvegen, Netherlands
Eindhoven, Netherlands
Tromso, Norway
Stavanger, Norway
Tonsberg, Norway
Drammen, Norway
Molde, Norway
Fredrikstad, Norway
Sandvika, Norway
Nordbyhagen, Norway
Lillehammer, Norway
Trondheim, Norway
Kielce, Poland
Zgierz, Poland
Czestochowa, Poland
Lodz, Poland
Warszawa, Poland
Poznan, Poland
Gdansk, Poland
Bydgoszcz, Poland
Krakow, Poland
Lublin, Poland
Olstyn, Poland
Bucuresti, Romania
Cluj-Napoca, Romania
Craiova, Romania
Moscow, Russian Federation
St. Petersburg, Russian Federation
Krasnoyasrk, Russian Federation
Dolni Kubin, Slovakia
Martin, Slovakia
Dubnica Nad Vahom, Slovakia
Bratislava, Slovakia
Zilina, Slovakia
Murcia, Spain
Leganes (Madrid), Spain
Badalona, Spain
Madrid, Spain
Barcelona, Spain
Castellon, Spain
Elda, Spain
Santa Cruz De Tenerife, Spain
Barakaldo Vizcaya, Spain
Sevilla, Spain
Vigo, Spain
Terrassa, Spain
Girona, Spain
Valencia, Spain
Mostoles, Spain
Varberg, Sweden
Stockholm, Sweden
Motala, Sweden
Karlstad, Sweden
Linkoping, Sweden
Lausanne, Switzerland
Biel, Switzerland
Geneve, Switzerland
Zurich, Switzerland
Bern, Switzerland
St. Gallen, Switzerland
Izmir, Turkey
Ankara, Turkey
Bursa, Turkey
Adana, Turkey
Istanbul, Turkey
Stoke on Trent, United Kingdom
Bangor, United Kingdom
Southampton, United Kingdom
London, United Kingdom
Ashford, United Kingdom
Truro, United Kingdom
Sunderland, United Kingdom
Plymouth, United Kingdom
Bristol, United Kingdom
Cardiff, United Kingdom
Dundee, United Kingdom
Swindon, United Kingdom
Liverpool, United Kingdom
Leeds, United Kingdom
Additional Information
Starting date: February 2005
Ending date: October 2007
Last updated: June 17, 2008
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