Conversion to Monotherapy Study With Keppra XR for Partial Seizures

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.

Intervention(s) in this Clinical Trial

• Drug: Keppra XR
  • Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks
• Drug: Keppra XR
  • Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Keppra XR 1000 mg/day
  • 1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily)
• Experimental: Keppra XR 2000 mg/day
  • 2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily)

Primary Measures

• The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
  • Time Frame: 112 days
    Safety Issue?: No

Secondary Measures

• The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
  • Time Frame: 112 days
    Safety Issue?: No
• The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
  • Time Frame: 112 days
    Safety Issue?: No
• The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
  • Time Frame: 112 days
    Safety Issue?: No

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 Investigator: UCB, Inc. Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

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

Product Information

FDA Safety Alerts and Recalls