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 (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam extended release formulation - XR
  • 500mg extended release oral tablet, 2 tablets once daily
• Other: Placebo
  • oral tablets, 2 tablets once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Levetiracetam
  • Levetiracetam extended release formulation (XR)
• Placebo Comparator: Placebo
  • placebo

Primary Measures

• partial onset seizure (POS) frequency per week
  • Time Frame: Treatment period (12 weeks)
    Safety Issue?: No

Secondary Measures

• All (Type I+II+III) seizures frequency per week
  • Time Frame: Treatment period (12 weeks)
    Safety Issue?: No
• 50% response in weekly POS frequency
  • Time Frame: Treatment period (12 weeks)
    Safety Issue?: No
• response in weekly POS frequency categorized into 6 categories < -25%; - 25% to <25%; 25% to <50%; 50% to <75%; 75% to <100%; 100%
  • Time Frame: Treatment period (12 weeks)
    Safety Issue?: No

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

UCB Clinical Trial Call Center Study Director +1 877 822 9493 (UCB)  

Information obtained from ClinicalTrials.gov on July 02, 2009

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