Clinical Trial: Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Double-blind, Randomized, Parallel Group, Positive-controlled Trial Comparing the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) to Carbamazepine (400 to 1200 mg

Brief Summary: A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized tonic-clonic seizures.

Detailed Summary:
Sponsor: UCB Pharma

Current Primary Outcome: To demonstrate that levetiracetam monotherapy is not inferior to carbamazepine by measuring the proportion of subjects with 6-month seizure freedom in subjects newly diagnosed as suffering from epilepsy.

Original Primary Outcome: Same as current

Current Secondary Outcome: Proportion of subjects with one year seizure freedom; time to first seizure; safety.

Original Secondary Outcome: Same as current

Information By: UCB Pharma

Dates:
Date Received: September 6, 2005
Date Started: June 2002
Date Completion:
Last Updated: November 25, 2013
Last Verified: July 2010