To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
116
Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.
Placebo solution, which is indistinguishable from the Levetiracetam oral solution.
Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)
Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for partial onset seizures divided by the total number of subjects. If a subject had \< 24 hours of usable Evaluation video-EEG time (including zero time available) and withdrawal from the study with reasons linked to lack or loss of efficacy, the subject was counted as a non-responder.
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Responder rate for total seizures (all types) as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)
Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for all seizure types divided by the total number of subjects. Subjects who withdrew or dropped out before the first 24 hours Evaluation video-EEG with reasons linked to lack of efficacy were considered as non-responders. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Percent reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement.
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Percent reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).
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Unnamed facility
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Los Angeles, California, United States
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Gainesville, Florida, United States
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Loxahatchee Groves, Florida, United States
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Miami, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
...and 76 more locations
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Absolute reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement.
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Absolute reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Percent reduction in Average Daily Frequency (ADF) of electro-clinical partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG for children 1 month to less than 6 months old
A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. For children 1 month to less than 6 months old, partial onset seizure counts were based on electroclinical seizures plus electrographic seizures.
Time frame: 48-hours in Evaluation Period and 48-hours in Selection Period
Percentage of drop-outs for any reasons during the study
Time frame: During the study (up to 20 days)
Percentage of drop-outs due to lack of efficacy during the study
Time frame: During the study (up to 20 days)
Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy
Time frame: During the study (up to 20 days)
Time to Exit (TTE) during the Evaluation Period
For early termination subjects in the Evaluation period the TTE is the time to discontinuing the study for any reason. TTE was defined as the day of study discontinuation - the day of randomization + 1. For completed subjects, the TTE was censored on Day 6.
Time frame: During Evaluation Period (Day 1 to Day 6)