Clinical trial NCT00152516: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy, Partial
Keywords: Partial Onset Seizures
levetiracetam
Epilepsy
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 255
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
timeFrame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Secondary outcomes:
measure: Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
timeFrame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
measure: Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
timeFrame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
measure: Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
timeFrame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
measure: Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
timeFrame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
measure: Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
timeFrame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
measure: Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
timeFrame: 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)
measure: Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
timeFrame: Subjects with up to 24 weeks of exposure
measure: Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
timeFrame: Subjects with greater than 24 weeks of exposure
measure: Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
timeFrame: Subjects with up to 24 weeks of exposure
measure: Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
timeFrame: Subjects with greater than 24 weeks of exposure
measure: Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
timeFrame: greater than or equal to 24 weeks, greater than or equal to 40 weeks
measure: Percent of Subjects With Each Seizure Type During the Evaluation Period
timeFrame: Evaluation period (48 weeks)
measure: Investigator Global Evaluation Scale
timeFrame: End of Evaluation period (week 48 or at point of early discontinuation)
measure: Parent/Guardian Global Evaluation Scale
timeFrame: End of Evaluation period (week 48 or at point of early discontinuation)
measure: Subject (>=8 Years Old) Global Evaluation Scale
timeFrame: End of Evaluation period (week 48 or at point of early discontinuation)
measure: 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)
timeFrame: Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
measure: 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)
timeFrame: Visit 5 (Week 24)
measure: 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)
timeFrame: Visit 7 (week 48)
measure: 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)
timeFrame: Visit 5 (week 24)
measure: 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)
timeFrame: Visit 7 (week 48)
Other outcomes:
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state: Kork
city: Berlin
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city: Moscow
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city: Capitol Park
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city: Johannesburg
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city: Bristol
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city: Cardiff
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city: London
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Study officials:
affiliation: +1 877 822 9493
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Pina-Garza JE, Schiemann-Delgado J, Yang H, Duncan B, Hadac J, Hunter SJ. Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: subpopulation analysis of a prospective, open-label extension study of up to 48 weeks. Clin Ther. 2010 Oct;32(11):1935-50. doi: 10.1016/j.clinthera.2010.09.017.