Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures

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(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.

Intervention(s) in this Clinical Trial

• Drug: levetiracetam (LEV)
  • Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Levetiracetam

Primary Measures

• Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
  • Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
    Safety Issue?: No

Secondary Measures

• Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
  • Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
    Safety Issue?: No
• Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
  • Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
    Safety Issue?: No
• Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
  • Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
    Safety Issue?: No
• Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
  • Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
    Safety Issue?: No
• Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
  • Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
    Safety Issue?: No
• Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
  • Time Frame: Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)
    Safety Issue?: No
• Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
  • Time Frame: Subjects with up to 24 weeks of exposure
    Safety Issue?: No
• Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
  • Time Frame: Subjects with greater than 24 weeks of exposure
    Safety Issue?: No
• Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
  • Time Frame: Subjects with up to 24 weeks of exposure
    Safety Issue?: No
• Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
  • Time Frame: Subjects with greater than 24 weeks of exposure
    Safety Issue?: No
• Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
  • Time Frame: greater than or equal to 24 weeks, greater than or equal to 40 weeks
    Safety Issue?: No
• Percent of Subjects With Each Seizure Type During the Evaluation Period
  • Time Frame: Evaluation period (48 weeks)
    Safety Issue?: No
• Investigator Global Evaluation Scale
  • Time Frame: End of Evaluation period (week 48 or at point of early discontinuation)
    Safety Issue?: No
• Parent/Guardian Global Evaluation Scale
  • Time Frame: End of Evaluation period (week 48 or at point of early discontinuation)
    Safety Issue?: No
• Subject (>=8 Years Old) Global Evaluation Scale
  • Time Frame: End of Evaluation period (week 48 or at point of early discontinuation)
    Safety Issue?: No
• Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)
  • Time Frame: Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
    Safety Issue?: Yes
• Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)
  • Time Frame: Visit 5 (Week 24)
    Safety Issue?: Yes
• Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)
  • Time Frame: Visit 7 (week 48)
    Safety Issue?: Yes
• Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)
  • Time Frame: Visit 5 (week 24)
    Safety Issue?: Yes
• Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)
  • Time Frame: Visit 7 (week 48)
    Safety Issue?: Yes

Inclusion Criteria:

• Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or N01103) or direct enrollment, for whom levetiracetam treatment will be of possible benefit

Exclusion Criteria:

• Patients on a ketogenic diet
• Seizures too close together to accurately count
• Pseudoseizures
• Status epilepticus 1 month prior Visit 1
• 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 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/NCT00152516

Study ID Number: N01148

ClinicalTrials.gov Identifier: NCT00152516

Health Authority: United States: Food and Drug Administration

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