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.

• Conditions: Monotherapy in subjects suffering from newly diagnosed epilepsy; MedDRA version: 6.1Level: HLGTClassification code 10039911

• Registration Number: EUCTR2004-001339-41-IT
• Lead Sponsor: CB PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-25
• Last Update Posted: 8 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ;Secondary Objective: ;Primary end point(s):