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Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Levetiracetam (Drug); Carbamazepine Controlled Release (CBZ-CR) (Drug); Valproate Extended Release (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UCB Pharma

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: UCB Pharma

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.

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety

Secondary outcome:

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

The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs

The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs

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

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

Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs

Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs

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

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

Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs

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

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

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

Brugge, Belgium

Dendermonde, Belgium

Edegem, Belgium

Gent, Belgium

Haine St Paul, Belgium

Jette, Belgium

Kortrijk, Belgium

Leuven, Belgium

Oostende, Belgium

Ottignies, Belgium

Plovdiv, Bulgaria

Sofia, Bulgaria

Varna, Bulgaria

Litomysl, Czech Republic

Ostrava-Poruba, Czech Republic

Zlin, Czech Republic

Aalborg, Denmark

Copenhagen, Denmark

Holbaek, 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 Cedex 9, France

La Seyne Sur Mer, France

Lille, France

Lyon, France

Marseille, France

Mulhouse, France

Nancy, France

Nimes, France

Paris, France

Rennes, France

Roanne, France

Saint Brieuc, France

Saint Quentin, France

Toulouse Cedex 04, France

Valenciennes, France

Vesoul, France

Altenburg, Germany

Arnsdorf, Germany

Aschaffenburg, Germany

Bamberg, Germany

Berlin - Hohenschonhausen, Germany

Berlin, Germany

Bernau, Germany

Bernburg, Germany

Bielefeld, Germany

Bonn, Germany

Butzbach, Germany

Celle, Germany

Dillingen, Germany

Dresden, Germany

Dusseldorf, Germany

Erbach, Germany

Essen, Germany

Giessen, Germany

Gottingen, Germany

Halle/Saale, Germany

Halle, Germany

Hamburg, Germany

Jena, Germany

Konigsbruck, Germany

Leipzig, Germany

Lengerich, Germany

Liegau-Augustusbad, Germany

Mittweida, Germany

Munster, Germany

Neukirchen-Vluyn, Germany

Neumunster, Germany

Oldenburg, Germany

Potsdam, Germany

Quickborn, Germany

Regenburg, Germany

Schalmstadt-Treysa, Germany

Siegen, Germany

Wermsdorf, Germany

Aklion, Greece

Alexandroupolis, Greece

Athens, Greece

Patras, Greece

Thessalonikis, Greece

Thessaloniki, Greece

Budapest, Hungary

Debrecen, Hungary

Pecs, Hungary

Dublin 9, Ireland

Dublin, Ireland

Ancona, Italy

Asti, Italy

Bari, Italy

Busto Arsizio, Italy

Casarano, Italy

Catania, Italy

Cremona, Italy

Eboli, Italy

Faenza, Italy

Ferrara, Italy

Firenze, Italy

Foggia, Italy

Forli, Italy

Garbagnate, Italy

Grosseto, Italy

Milano, Italy

Napoli, Italy

Padova, 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

Tonsberg, Norway

Tromso, Norway

Trondheim, Norway

Bydgoszcz, Poland

Czestochowa, Poland

Gdansk, Poland

Kielce, Poland

Krakow, Poland

Lodz, Poland

Lublin, Poland

Olstyn, Poland

Poznan, Poland

Warszawa, Poland

Zgierz, Poland

Bucuresti, Romania

Cluj-Napoca, Romania

Craiova, Romania

Krasnoyasrk, Russian Federation

Moscow, Russian Federation

St. Petersburg, Russian Federation

Bratislava, Slovakia

Dolni Kubin, Slovakia

Dubnica Nad Vahom, Slovakia

Martin, Slovakia

Zilina, Slovakia

Badalona, Spain

Barakaldo Vizcaya, Spain

Barcelona, Spain

Castellon, Spain

Elda, Spain

Girona, Spain

Leganes (Madrid), Spain

Madrid, Spain

Mostoles, Spain

Murcia, Spain

Santa Cruz De Tenerife, Spain

Sevilla, Spain

Terrassa, Spain

Valencia, Spain

Vigo, Spain

Karlstad, Sweden

Linkoping, Sweden

Motala, Sweden

Stockholm, Sweden

Varberg, Sweden

Bern, Switzerland

Biel, Switzerland

Geneve, Switzerland

Lausanne, Switzerland

St. Gallen, Switzerland

Zurich, Switzerland

Adana, Turkey

Ankara, Turkey

Bursa, Turkey

Istanbul, Turkey

Izmir, Turkey

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

Additional Information

Clinical Study Summary on UCB.com

Starting date: February 2005
Last updated: March 12, 2015

Page last updated: August 23, 2015

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