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

Verified by: UCB, Inc., December 2009
First Received: August 11, 2006 | Last Updated: August 30, 2011 | Phase: Phase 3 | Start Date: August 2006
Overall Status: Completed | Estimated Enrollment: 158
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This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy...

Brief Summary

Official Title: “A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - 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 - XR in patients with epilepsy.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Keppra® XR
    • Keppra® extended release formulation -XR
  • Placebo Comparator: Placebo
    • placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
    • Time Frame: Treatment period (12 weeks)
      Safety Issue?: No
  • Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population
    • Time Frame: Treatment Period (12 weeks)
      Safety Issue?: No

Secondary Measures

  • POS Seizure Frequency Per Week Over Baseline and Treatment Period
    • Time Frame: Baseline Period (8 weeks) - Treatment Period (12 weeks)
      Safety Issue?: No
  • 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 According to Reduction) Over the Treatment Period of 12 Weeks
    • Time Frame: over the 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 Anti-Epileptic Drugs (AED).
  • 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 Investigator Information

Lead Investigator: UCB, Inc. Industry

Overall Clinical Trial Officials and Contacts

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

Related Publications

Citations Reporting Results

Peltola J, Coetzee C, Jiménez F, Litovchenko T, Ramaratnam S, Zaslavaskiy L, Lu ZS, Sykes DM; Levetiracetam XR N01235 Study Group. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2009 Mar;50(3):406-14.

Richy FF, Banerjee S, Brabant Y, Helmers S. Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques. Epilepsy Behav. 2009 Oct;16(2):240-5. Epub 2009 Aug 20.

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

Product Information

FDA Safety Alerts and Recalls

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00368069