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: March 7, 2008

Verified by: UCB, March 2008

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

Overall Status: Completed

Estimated Enrollment: 130

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, Placebo Control, Parallel Assignment

Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

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

Outcome Measures for this Clinical Trial

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%)

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

Sarah Lu, MD, PhD Study Director UCB  

Additional Information

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

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