Official Title: “A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.”

To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009/N01103 or by direct enrollment) open-label levetiracetam treatment, continue studying potential cognitive and behavioral effects in children, and continue collection of safety/efficacy data.

Study Type: Interventional

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

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam
  • Oral Solution and tablets 20mg to 80 mg/kg/day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• To obtain long-term descriptive safety and efficacy data in pediatric epileptic patients with partial onset seizures receiving long-term treatment with levetiracetam at individualized doses.
  • Time Frame: 48 weeks
    
• Efficacy assessed by measuring the percentage change of Partial Type 1 seizure frequency per week over time from baseline during the treatment period
  • Time Frame: 48 weeks
    

Secondary Measures

• Total and partial seizure frequency per week over time. Change from baseline of partial and total seizure frequency per week over time.
  • Time Frame: 48 weeks
    
• Responder rates, maximum seizure-free interval and continuously seizure-free
  • Time Frame: 48 weeks
    

Inclusion Criteria:

• Pediatric patients with partial onset seizures, with or without participation in previous levetiracetam pediatric studies (N01009 or N01103) for whom levetiracetam treatment will be of possible benefit

Exclusion Criteria:

• Patients on a ketogenic diet
• Seizures too close together to accurately count
• Treatable seizure etiology
• Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Month

Maximum Age for this Clinical Trial: 16 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  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00152516

Study ID Number: N01148

ClinicalTrials.gov Identifier: NCT00152516

Health Authority: United States: Food and Drug Administration