Official Title: “A Double-Blind, Placebo-Controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation LEV XR Once Daily as Add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures.”

This is a safety and efficacy study of Keppra® extended release formulation in patients with epilepsy.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

• Drug: Keppra® (Levetiracetam) extended release formulation - XR

Primary Measures

• partial onset seizure frequency reduction

Secondary Measures

• Total seizure frequency reduction
• Responder rate
• The categorical response to treatment (< -25%, -25% to < 25%, 25% to < 50%, 50% to < 75%, 75% to < 100% and 100%)

Inclusion Criteria:

• Patients with a confirmed diagnosis of refractory epilepsy Patients must be receiving 1 - 3 concomitant AEDs.
• Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method.

Exclusion Criteria:

• Seizures occurring in clusters
• Status epilepticus within 3 months of Visit 1.
• History of non-epileptic seizures.
• Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients.
• Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Sarah Lu, MD, PhD Study Director UCB  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00368069

Study ID Number: N01235

ClinicalTrials.gov Identifier: NCT00368069

Health Authority: Russia: Pharmacological Committee, Ministry of Health