Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
Open label, multicenter, international, randomized, parallel group, phase IIIb study comparing the efficacy and safety of levetiracetam to two standard antiepileptic drugs (CBZ and VPA) in patients with newly diagnosed epilepsy in a clinical practice setting.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- TIME TO WITHDRAWAL OF STUDY MEDICATION AS A COMBINED MEASURE OF EFFICACY AND SAFETY
- EFFICACY:RETENTION RATE; SEIZURE FREEDOM AT 6 AND 12 MONTHS; TIME TO FIRST SEIZURE.
|Study Start Date:||February 2005|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175903
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|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|