Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures

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 subjects with partial onset seizures.

Intervention(s) in this Clinical Trial

• Drug: Keppra XR (Levetiracetam XR)
  • 500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Keppra XR (Levetiracetam XR)
  • 1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)

Primary Measures

• Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
  • Time Frame: Duration of the Treatment Period (6 months-2 years)
    Safety Issue?: No
• Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
  • Time Frame: Duration of the Treatment Period (6 months-2 years)
    Safety Issue?: No
• Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period
  • Time Frame: Duration of the Treatment Period (6 months-2 years)
    Safety Issue?: No

Secondary Measures

• Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
  • Time Frame: Study entry through 6 months
    Safety Issue?: No
• Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
  • Time Frame: Study entry through 12 months
    Safety Issue?: No

Inclusion Criteria:

• Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period

Exclusion Criteria:

• Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]
• 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 Investigator: UCB, Inc. Industry

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 February 12, 2012

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

FDA Safety Alerts and Recalls

Product Information