Official Title: “An Open-Label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-Onset Seizures”

To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in patients with partial onset seizures.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Study Primary Completion Date: June 2010

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam XR
  • 500mg tablets 1000 - 3000mg/day flexible dosing duration of the trial

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 1000 - 3000 mg/day Keppra XR (Levetiracetam XR)

Primary Measures

• The primary endpoint is the evaluation of the long-term safety of Keppra XR in patients with partial onset seizures.
  • Time Frame: 2 - 3 years
    

Inclusion Criteria:

• Subjects who were randomized into study N01280 and completed the 2-week up titration period

Exclusion Criteria:

• Subjects who did not meet the inclusion/exclusion criteria for N01280.
• Subjects who were discontinued prior to the end of titration period.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00419393

Study ID Number: N01281

ClinicalTrials.gov Identifier: NCT00419393

Health Authority: United States: Food and Drug Administration