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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Levetiracetam
Carbamazepine Controlled Release (CBZ-CR)
Valproate Extended Release
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Newly Diagnosed Epilepsy, Levetiracetam, Keppra, Carbamazepine, Valproate

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Levetiracetam

Older Antepileptic Drugs

Arm Description

Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.

Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2005
Last Updated
March 12, 2015
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00175903
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Newly Diagnosed Epilepsy, Levetiracetam, Keppra, Carbamazepine, Valproate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1701 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Experimental
Arm Description
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Arm Title
Older Antepileptic Drugs
Arm Type
Active Comparator
Arm Description
Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Intervention Description
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Carbamazepine Controlled Release (CBZ-CR)
Intervention Description
Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Valproate Extended Release
Intervention Description
Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
Primary Outcome Measure Information:
Title
Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety
Time Frame
Visit 1 to End of Study (approximately 52 weeks)
Secondary Outcome Measure Information:
Title
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
Time Frame
Visit 1 to End of Study (approximately 52 weeks)
Title
The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs
Time Frame
Visit 1 to Visit 4 (approximately 26 weeks)
Title
The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs
Time Frame
Visit 1 to Visit 5 (approximately 52 weeks)
Title
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
Time Frame
Visit 1 to Visit 4 (approximately 26 weeks)
Title
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
Time Frame
Visit 1 to Visit 5 (approximately 52 weeks)
Title
Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs
Time Frame
Visit 1 to Visit 4 (approximately 26 weeks)
Title
Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs
Time Frame
Visit 1 to Visit 5 (approximately 52 weeks)
Title
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
Time Frame
Visit 1 to Visit 4 (approximately 26 weeks)
Title
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 Frame
Visit 1 to Visit 5 (approximately 52 weeks)
Title
Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs
Time Frame
Visit 1 to End of Study (approximately 52 weeks)
Title
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
Time Frame
Visit 1 to End of Study (approximately 52 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
City
Adelaide
Country
Australia
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Bedford Park
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Australia
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Brisbane
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Australia
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Cairns
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Australia
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Camperdown
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Australia
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Chatswood
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Australia
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Clayton
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Australia
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Maroochydore
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Australia
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Parkville
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Australia
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Perth
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Australia
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Randwick
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Australia
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West Heidelberg
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Australia
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Graz
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Austria
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Innsbrick
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Austria
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Klagenfurt
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Austria
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Linz
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Austria
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Steyr
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Austria
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Vienna
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Austria
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Brugge
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Belgium
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Dendermonde
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Haine St Paul
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Belgium
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Jette
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Oostende
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Belgium
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Ottignies
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Belgium
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Bulgaria
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Litomysl
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Czech Republic
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Ostrava-Poruba
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Czech Republic
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Zlin
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Czech Republic
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Aalborg
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Denmark
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Copenhagen
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Denmark
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Holbaek
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Denmark
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Holstebro
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Denmark
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Hus (Helsinki)
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Finland
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Kuopio
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Finland
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Tampere
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Finland
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Blaye
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France
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Bordeaux
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France
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Brest
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France
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Carcassonne
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France
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Cherbourg
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France
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Colmar
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France
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Creil
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France
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Dijon
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France
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Freyming Merlebach
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France
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Grenoble Cedex 9
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France
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La Seyne Sur Mer
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France
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Lille
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France
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Lyon
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France
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Marseille
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France
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Mulhouse
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France
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Nancy
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France
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Nimes
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France
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Paris
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France
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Rennes
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France
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Roanne
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France
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Saint Brieuc
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France
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Saint Quentin
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France
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Toulouse Cedex 04
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France
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Valenciennes
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France
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Vesoul
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France
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Altenburg
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Germany
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Arnsdorf
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Germany
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Aschaffenburg
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Germany
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Bamberg
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Germany
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Berlin - Hohenschonhausen
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Germany
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Berlin
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Germany
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Bernau
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Germany
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Bernburg
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Germany
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Bielefeld
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Germany
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Bonn
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Germany
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Butzbach
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Germany
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Celle
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Germany
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Dillingen
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Germany
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Dresden
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Germany
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Dusseldorf
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Germany
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Erbach
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Germany
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Essen
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Germany
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Giessen
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Germany
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Gottingen
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Germany
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Halle/Saale
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Germany
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Halle
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Germany
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Hamburg
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Germany
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Jena
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Germany
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Konigsbruck
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Germany
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Leipzig
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Germany
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Lengerich
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Germany
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Liegau-Augustusbad
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Germany
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Mittweida
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Germany
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Munster
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Germany
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Neukirchen-Vluyn
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Germany
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Neumunster
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Germany
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Oldenburg
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Germany
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Potsdam
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Germany
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Quickborn
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Germany
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Regenburg
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Germany
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Schalmstadt-Treysa
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Germany
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Siegen
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Germany
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Wermsdorf
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Germany
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Aklion
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Greece
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Alexandroupolis
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Greece
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Athens
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Greece
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Patras
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Greece
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Greece
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Greece
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Budapest
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Hungary
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Debrecen
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Hungary
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Hungary
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Dublin 9
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Ireland
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Dublin
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Ireland
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Italy
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Asti
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Italy
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Bari
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Italy
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Busto Arsizio
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Italy
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Casarano
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Italy
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Catania
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Italy
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Cremona
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Italy
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Eboli
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Italy
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Faenza
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Italy
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Ferrara
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Italy
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Firenze
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Italy
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Foggia
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Italy
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Forli
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Italy
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Garbagnate
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Italy
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Grosseto
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Italy
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Milano
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Italy
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Napoli
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Italy
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Padova
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Italy
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Perugia
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Italy
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Pescara
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Italy
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Pisa
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Italy
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Potenza
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Italy
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Prato
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Italy
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Ragusa
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Siena
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Italy
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Taranto
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Italy
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Torino
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Italy
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Udine
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Italy
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Verona
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Italy
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Vimercate
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Italy
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Vittoria
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Italy
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Eindhoven
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Netherlands
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Heerenvegen
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Netherlands
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Leeuwarden
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Netherlands
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Maastricht
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Netherlands
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Nijmegen
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Netherlands
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Tilburg
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Netherlands
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Drammen
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Norway
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Fredrikstad
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Norway
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Lillehammer
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Norway
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Molde
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Norway
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Nordbyhagen
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Norway
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Sandvika
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Norway
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Stavanger
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Norway
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Tonsberg
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Norway
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Tromso
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Norway
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Trondheim
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Norway
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Bydgoszcz
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Poland
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Czestochowa
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Poland
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Gdansk
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Poland
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Kielce
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Olstyn
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Poland
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Poznan
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Poland
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Warszawa
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Poland
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Zgierz
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Poland
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Krasnoyasrk
Country
Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Russian Federation
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Bratislava
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Slovakia
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Dolni Kubin
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Slovakia
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Dubnica Nad Vahom
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Slovakia
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Martin
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Slovakia
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Zilina
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Slovakia
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Badalona
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Spain
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Barakaldo Vizcaya
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Spain
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Barcelona
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Spain
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Castellon
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Spain
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Elda
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Spain
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Girona
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Spain
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Leganes (Madrid)
Country
Spain
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Madrid
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Spain
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Mostoles
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Spain
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Murcia
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Spain
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Santa Cruz De Tenerife
Country
Spain
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Sevilla
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Spain
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Terrassa
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Spain
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Valencia
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Spain
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Vigo
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Spain
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Karlstad
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Sweden
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Linkoping
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Sweden
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Motala
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Sweden
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Stockholm
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Sweden
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Varberg
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Sweden
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Bern
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Switzerland
City
Biel
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Switzerland
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Geneve
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Switzerland
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Lausanne
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Switzerland
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St. Gallen
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Switzerland
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Zurich
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Switzerland
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Adana
Country
Turkey
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Ankara
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Turkey
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Bursa
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Ashford
Country
United Kingdom
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Bangor
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United Kingdom
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Bristol
Country
United Kingdom
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Cardiff
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United Kingdom
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Dundee
Country
United Kingdom
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Leeds
Country
United Kingdom
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Liverpool
Country
United Kingdom
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London
Country
United Kingdom
City
Plymouth
Country
United Kingdom
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Southampton
Country
United Kingdom
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Stoke on Trent
Country
United Kingdom
City
Sunderland
Country
United Kingdom
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Swindon
Country
United Kingdom
City
Truro
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27552848
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.
Results Reference
derived
PubMed Identifier
22933814
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.
Results Reference
derived

Learn more about this trial

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

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