A Study to Look at the Efficacy and Safety of Keppra® Extended Release

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

Date First Received: August 11, 2006

Last Updated: February 26, 2009

Verified by: UCB, February 2009

Clinical Trial Phase: Phase 3 | Start Date: August 2006

Overall Status: Completed

Estimated Enrollment: 158

Brief Summary

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.”

Condition Keyword(s):

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Sponsor Information

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

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

Additional Information

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

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