NCT00175903

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,701 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Levetiracetam	Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
DRUG	Carbamazepine Controlled Release (CBZ-CR)	Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
DRUG	Valproate Extended Release	Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2005-09-15
• Last updated: 2015-03-17

Locations

229 sites across 24 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