A Phase 3 interventional study of Levetiracetam and Placebo in Epilepsy, Partial, sponsored by UCB Pharma. Completed at 88 sites in 15 countries. Open to participants aged 1 Month to 4 Years. Per ClinicalTrials.gov, last updated 2020-10-01.
Sponsored by UCB Pharma · Phase 3, Interventional, and Treatment
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.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's enrollment of 116 is above the median of 64 across 610 interventional studies indexed under Seizures.
Browse Seizures studies →UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
Other: Placebo
10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
Drug: Levetiracetam
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.
Also known as: Keppra
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).
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)
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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