Epilepsy
Conditions
Keywords
Newly Diagnosed Epilepsy, Levetiracetam, Keppra, Carbamazepine, Valproate
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.
Interventions
DRUGLevetiracetam
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
DRUGCarbamazepine Controlled Release (CBZ-CR)
Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
DRUGValproate Extended Release
Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety | Visit 1 to End of Study (approximately 52 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs | Visit 1 to Visit 4 (approximately 26 weeks) |
| The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs | 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 | 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 | Visit 1 to Visit 5 (approximately 52 weeks) |
| Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs | Visit 1 to Visit 4 (approximately 26 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 | Visit 1 to End of Study (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 | 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 | Visit 1 to Visit 5 (approximately 52 weeks) |
| Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs | 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 | Visit 1 to End of Study (approximately 52 weeks) |
| Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs | Visit 1 to Visit 5 (approximately 52 weeks) |
Countries
Australia, Austria, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Romania, Russia, Slovakia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Outcome results
None listed