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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00175903




Registration number
NCT00175903
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
17/03/2015

Titles & IDs
Public title
Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
Scientific 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.
Secondary ID [1] 0 0
2004-001339-41
Secondary ID [2] 0 0
N01175
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Levetiracetam
Treatment: Drugs - Carbamazepine Controlled Release (CBZ-CR)
Treatment: Drugs - Valproate Extended Release

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

Active comparator: Older Antepileptic Drugs - Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.


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

Treatment: Drugs: Carbamazepine Controlled Release (CBZ-CR)
Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.

Treatment: Drugs: Valproate Extended Release
Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety
Timepoint [1] 0 0
Visit 1 to End of Study (approximately 52 weeks)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Visit 1 to End of Study (approximately 52 weeks)
Secondary outcome [2] 0 0
The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs
Timepoint [2] 0 0
Visit 1 to Visit 4 (approximately 26 weeks)
Secondary outcome [3] 0 0
The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs
Timepoint [3] 0 0
Visit 1 to Visit 5 (approximately 52 weeks)
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Visit 1 to Visit 4 (approximately 26 weeks)
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Visit 1 to Visit 5 (approximately 52 weeks)
Secondary outcome [6] 0 0
Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs
Timepoint [6] 0 0
Visit 1 to Visit 4 (approximately 26 weeks)
Secondary outcome [7] 0 0
Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs
Timepoint [7] 0 0
Visit 1 to Visit 5 (approximately 52 weeks)
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Visit 1 to Visit 4 (approximately 26 weeks)
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Visit 1 to Visit 5 (approximately 52 weeks)
Secondary outcome [10] 0 0
Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs
Timepoint [10] 0 0
Visit 1 to End of Study (approximately 52 weeks)
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Visit 1 to End of Study (approximately 52 weeks)

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2007
Sample size
Target
Accrual to date
Final
1701
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Bedford Park
Recruitment hospital [3] 0 0
- Brisbane
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- Cairns
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- Camperdown
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- Chatswood
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- Clayton
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- Maroochydore
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- Parkville
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- Perth
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- Randwick
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- West Heidelberg
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- Parkville
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- Perth
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- Randwick
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- West Heidelberg
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Graz
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Turkey
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Bursa
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Istanbul
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Izmir
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Ashford
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Bangor
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Bristol
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Cardiff
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Dundee
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Leeds
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Liverpool
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London
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Plymouth
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Southampton
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Stoke on Trent
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Sunderland
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Swindon
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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UCB Pharma
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Ethics approval
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Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00175903
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
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UCB Clinical Trial Call Center
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UCB Pharma
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00175903