Official Title: “A Multi-Center, Double-Blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures”

The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Historical Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam XR
  • 500mg tablets, 2 x 500mg (1000mg)once daily for 18 weeks
• Drug: Levetiracetam XR
  • 500mg tablets, 4 x 500mg (2000mg)once daily for 18 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 1000mg/day Levetiracetam XR
• Experimental: 2
  • 2000mg/day Levetiracetam XR

Primary Measures

• The primary efficacy endpoint is the cummulative exit rate at 112 days after the beginning of the previous AED tapering phase.
  • Time Frame: 112 days
    

Secondary Measures

• The cumulative rate of exit events, which include discontinuation due to exit criteria, withdrawal due to AE and withdrawal due to lack of efficacy, at 112 days after the beginning of previous AED tapering period.
  • Time Frame: 112 days
    
• The cumulative rate of exit events due to any reasons at 112 days after the beginning of previous AED tapering period.
  • Time Frame: 112 days
    

Inclusion Criteria:

• Male or female subjects 12 to 75 years of age.
• Subjects must have inadequately controlled partial onset epilepsy.
• Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s)

Exclusion Criteria:

• A history of status epilepticus in the 6 months preceding randomization.
• Significant medical, psychiatric or neurological illness.
• Intake of benzodiazepines on more than an occasional basis
• History of previous treatment with levetiracetam or sensitivity to levetiracetam.

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 Study Director +1 877 822 9493  

Overall Contact: UCB Clinical Trial Call Center +1 877 822 9493 

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00419094

Study ID Number: N01280

ClinicalTrials.gov Identifier: NCT00419094

Health Authority: United States: Food and Drug Administration