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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,701
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
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)
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)
The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs
Time frame: Visit 1 to Visit 4 (approximately 26 weeks)
The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs
Time frame: Visit 1 to Visit 5 (approximately 52 weeks)
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)
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)
Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs
Time frame: Visit 1 to Visit 4 (approximately 26 weeks)
Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs
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Adelaide, Australia
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Bedford Park, Australia
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Brisbane, Australia
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Cairns, Australia
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Camperdown, Australia
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Chatswood, Australia
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Clayton, Australia
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Maroochydore, Australia
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Parkville, Australia
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Perth, Australia
...and 219 more locations
Time frame: Visit 1 to Visit 5 (approximately 52 weeks)
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)
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)
Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs
Time frame: Visit 1 to End of Study (approximately 52 weeks)
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)